{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Dover", "address_1": "200 W Ohio Ave", "reason_for_recall": "Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.", "address_2": "", "product_quantity": "8,231 devices total", "code_info": "Lot No. Item No. 60400040400, Lot No. 62510548 (Serial Numbers: 2213JAAA, 2213JAAB, 2213JAAC, 2213JAAD, 2213JAAE, 2213JAAF, 2213JAAG, 2213JAAH, 2213JAAJ, 2213JAAK, 2213JAAL, 2213JAAM, 2213JAAN, 2213JAAP, 2213JAAQ, 2213JAAR, 2213JAAS, 2213JAAT, 2213JAAU, 2213JAAW, 2213JABA, 2213JABB, 2213JABC, 2213JABD, 2213JABE, 2213JABF, 2213JABG, 2213JABH); Lot No. 62534445 (Serial Numbers: 2213JABJ, 2213JABK, 2213JABL, 2213JABM, 2213JABN, 2213JABP, 2213JABQ, 2213JABR, 2213JABS, 2213JABT, 2213JABU, 2213JABW, 2213JACA, 2213JACB, 2213JACC, 2213JACD, 2213JACE, 2213JACF, 2213JACG, 2213JACH); Lot No. 62631977 (Serial Numbers: 2214BAAA, 2214BAAB, 2214BAAC, 2214BAAD, 2214BAAE, 2214BAAF, 2214BAAG, 2214BAAH, 2214BAAJ, 2214BAAK, 2214BAAL, 2214BAAM, 2214BAAN, 2214BAAP, 2214BAAQ, 2214BAAR, 2214BAAS, 2214BAAT, 2214BAAU, 2214BAAW); Lot No. 62625059 (Serial Numbers: 2214BABA, 2214BABB, 2214BABC, 2214BABD, 2214BABE, 2214BABF, 2214BABG, 2214BABH, 2214BABJ, 2214BABK, 2214BABL, 2214BABM, 2214BABN, 2214BABP, 2214BABQ, 2214BABR, 2214BABS, 2214BABT, 2214BABU, 2214BABW); Lot No. 62635789 (Serial Numbers: 2214CAAA, 2214CAAB, 2214CAAC, 2214CAAD, 2214CAAE, 2214CAAF, 2214CAAG, 2214CAAH, 2214CAAJ, 2214CAAK, 2214CAAL, 2214CAAM, 2214CAAV, 2214CAAP, 2214CAAQ, 2214CAAR, 2214CAAS, 2214CAAT, 2214CAAU, 2214CAAW); Lot No. 62642067 (Serial Numbers: 2214DAAA, 2214DAAB, 2214DAAC, 2214DAAD, 2214DAAE, 2214DAAF, 2214DAAG, 2214DAAH, 2214DAAJ, 2214DAAK, 2214DAAL, 2214DAAM, 2214DAAN, 2214DAAP, 2214DAAQ, 2214DAAR, 2214DAAS, 2214DAAT, 2214DAAU, 2214DAAW); Lot No. 62642068 (Serial Numbers: 2214EAAA, 2214EAAB, 2214EAAC, 2214EAAD, 2014EAAE, 2214EAAF, 2214EAAG, 2214EAAH, 2214EAAJ, 2214EAAK, 2214EAAL, 2214EAAM, 2214EAAN, 2214EAAP, 2214EAAQ, 2214EAAR, 2214EAAS, 2214EAAT, 2214EAAU, 2214EAAW); Lot No. 62675190 (Serial Numbers: 2214DABA); Lot No. 62732714 (Serial Numbers: 2214FAAA, 2214FAAB, 2214FAAC, 2214FAAD); Lot No. 62727347 (Serial Numbers: 2214FAAE, 2214FAAF, 2214FAAG, 2214FAAH); Lot No. 62727348 (Serial Numbers: 2214FAAJ, 2214FAAK, 2214FAAL); Lot No. 62745916 (Serial Numbers: 2214FAAM, 2214FAAN); Lot No. 62723747 (Serial Numbers: 2214FAAP, 2214FAAQ, 2214FAAR, 2214FAAS, 2214FAAT, 2214FAAU, 2214FAAW, 2214FABA, 2214FABB, 2214FABC, 2214FABD, 2214FABE, 2214FABF, 2214FABG, 2214FABH, 2214FABJ, 2214FABK, 2214FABL, 2214FABM, 2214FABN); Lot No. 62723748 (Serial Numbers: 2214FABP, 2214FABQ, 2214FABR, 2214FABS, 2214FABT, 2214FABU, 2214FABW, 2214FACA, 2214FACB, 2214FACC, 2214FACD, 2214FACE, 2214FACF, 2214FACG, 2214FACH, 2214FACJ, 2214FACK, 2214FACL, 2214FACM, 2214FACN); Lot No. 62758708 (Serial Numbers: 2214GAAA, 2214GAAB, 2214GAAC, 2214GAAD); Lot No. 62758711 (Serial Numbers: 2214GAAE); Lot No. 62760907 (Serial Numbers: 2214GAAF, 2214GAAG); Lot No. 63773338 (Serial Numbers: 2214GAAH, 2214GAAJ, 2214GAAK, 2214GAAL); Lot No. 62773820 (Serial Numbers: 2214GAAM, 2214GAAN); Lot No. 62773463 (Serial Numbers: 2214GAAP); Lot No. 62773471 (Serial Numbers: 2214GAAQ, 2214GAAR, 2214GAAS); Lot No. 62773478 (Serial Numbers: 2214GAAT, 2214GAAU, 2214GAAW, 2214GABA); Lot No. 62773485 (Serial Numbers: 2214GABB, 2214GABC); Lot No. 62748403 (Serial Numbers: 2214GABD, 2214GABE, 2214GABF, 2214GABG, 2214GABH, 2214GABJ, 2214GABK, 2214GABL, 2214GABM, 2214GABN, 2214GABP, 2214GABQ, 2214GABR, 2214GABS, 2214GABT, 2214GABU, 2214GABW, 2214GACA, 2214GACB, 2214GACC); Lot No. 62779664 (Serial Numbers: 2214GACD, 2214GACE); Lot No. 62797832 (Serial Numbers: 2214HAAA, 2214HAAB, 2214HAAC); Lot No. 62797833 (Serial Numbers: 2214HAAD, 2214HAAE, 2214HAAF, 2214HAAG, 2214HAAH); Lot No. 62799449 (Serial Numbers: 2214HAAJ, 2214HAAK, 2214HAAL, 2214HAAM, 2214HAAN, 2214HAAP, 2214HAAQ, 2214HAAR, 2214HAAS, 2214HAAT, 2214HAAU, 2214HAAW, 2214HABA, 2214HABB, 2214HABC, 2214HABD, 2214HABE, 2214HABF, 2214HABG, 2214HABH); Lot No. 62799475 (Serial Numbers: 2214HABJ, 2214HABK, 2214HABL, 2214HABM, 2214HABN, 2214HABP, 2214HABQ, 2214HABR, 2214HABS, 2214HABT, 2214HABU, 2214HABW, 2214HACA, 2214HACB, 2214HACC, 2214HACD, 2214HACE, 2214HACF, 2214HACG, 2214HACH); Lot No. 62824836 (Serial Numbers: 2214IAAA, 2214IAAB, 2214IAAC, 2214IAAD); Lot No. 62838042 (Serial Numbers: 2214IAAE, 2214IAAF, 2214IAAG, 2214IAAH); Lot No. 62812885 (Serial Numbers: 2214IAAJ, 2214IAAK, 2214IAAL, 2214IAAM, 2214IAAN, 2214IAAP, 2214IAAQ, 2214IAAR, 2214IAAS, 2214IAAT, 2214IAAU, 2214IAAW, 2214IABA, 2214IABB, 2214IABC, 2214IABD, 2214IABE, 2214IABF, 2214IABG, 2214IABH); Lot No. 62812853 (Serial Numbers: 2214IABJ, 2214IABK, 2214IABL, 2214IABM, 2214IABN, 2214IABP, 2214IABQ, 2214IABR, 2214IABS, 2214IABT, 2214IABU, 2214IABW, 2214IACA, 2214IACB, 2214IACC, 2214IACD, 2214IACE, 2214IACF, 2214IACG, 2214IACH); Lot No. 62846159 (Serial Numbers: 2214JAAA, 2214JAAB, 2214JAAC); Lot No. 62844916 (Serial Numbers: 2214JAAD); Lot No. 62869981 (Serial Numbers: 2214KAAE, 2214KAAF, 2214KAAG, 2214KAAH, 2214KAAJ); Lot No. 62871639 (Serial Numbers: 2214JAAE, 2214JAAF, 2214JAAG, 2214JAAH); Lot No. 62870928 (Serial Numbers: 2214KAAK, 2214KAAL, 2214KAAM, 2214KAAN, 2214KAAP, 2214KAAQ, 2214KAAR, 2214KAAS, 2214KAAT, 2214KAAU, 2214KAAW, 2214KABA, 2214KABB, 2214KABC, 2214KABD, 2214KABE, 2214KABF, 2214KABG, 2214KABH, 2214KABJ); Lot No. 62877932 (Serial Numbers: 221411110001, 221411110002, 221411110003, 221411110004, 221411110005, 221411110006, 221411110007, 221411110008, 221411110009, 221411110010); Lot No. 62885586 (Serial Numbers: 221411120001, 221411120002, 221411120003, 221411120004, 221411120005); Lot No. 62885587 (Serial Numbers: 221411120006, 221411120007, 221411120008, 221411120009, 221411120010, 221411120011, 221411120012, 221411120013, 221411120014, 221411120015); Lot No. 62895898 (Serial Numbers: 221411200001, 221411200002, 221411200003, 221411200004, 221411200005, 221411200006, 221411200007, 221411200008, 221411200009, 221411200010); Lot No. 62905257 (Serial Numbers: 221411240001); Lot No. 62904091 (Serial Numbers: 221411250001, 221411250002, 221411250003, 221411250004, 221411250005, 221411250006, 221411250007, 221411250008, 221411250009, 221411250010, 221411250011, 221411250012, 221411250013, 221411250014, 221411250015, 221411250016, 221411250017, 221411250018, 221411250019, 221411250020); Lot No. 62904093 (Serial Numbers: 221412010001, 221412010002, 221412010003, 221412010004, 221412010005, 221412010006, 221412010007, 221412010008, 221412010009, 221412010010, 221412010011, 221412010012, 221412010013, 221412010014, 221412010015, 221412010016, 221412010017, 221412010018, 221412010019, 221412010020); Lot No. 62879139 (Serial Numbers: 221412040001, 221412040002, 221412040003, 221412040004, 221412040005); Lot No. 62905838 (Serial Numbers: 221412080001, 221412080002, 221412080003, 221412080004, 221412080005); Lot No. 62895896 (Serial Numbers: 221412120001, 221412120002, 221412120003, 221412120004, 221412120005); Lot No. 62904123 (Serial Numbers: 221412150001, 221412150002, 221412150003, 221412150004, 221412150005, 221412150006, 221412150007, 221412150008, 221412150009, 221412150010, 221412150011, 221412150012, 221412150013, 221412150014, 221412150015, 221412150016, 221412150017, 221412150018, 221412150019, 221412150020); Lot No. 62932244 (Serial Numbers: 221412180001, 221412180002, 221412180003, 221412180004, 221412180005, 221412180006, 221412180007, 221412180008, 221412180009, 221412180010, 221412180011, 221412180012, 221412180013, 221412180014, 221412180015, 221412180016, 221412180017, 221412180018, 221412180019, 221412180020); Lot No. 62935217 (Serial Numbers: 221412190001, 221412190002, 221412190003, 221412190004, 221412190005); Lot No. 62937693 (Serial Numbers: 221501050001, 221501050002, 221501050003, 221501050004, 221501050005); Lot No. 62945082 (Serial Numbers: 221501080001, 221501080002, 221501080003, 221501080004, 221501080005); Lot No. 62945086 (Serial Numbers: 201501080006, 201501080007, 201501080008); Lot No. 62932650 (Serial Numbers: 221503090001, 221503090002, 221503090003, 221503090004, 221503090005, 221503090006, 221503090007, 221503090008, 221503090009, 221503090010, 221503090011, 221503090012, 221503090013, 221503090014, 221503090015, 221503090016, 221503090017, 221503090018, 221503090019, 22150309002); Lot No. 62961804 (Serial Numbers: 221503120001, 221503120002, 221503120003, 221503120004, 221503120005, 221503120006, 221503120007, 221503120008, 221503120009, 221503120010, 221503120011, 221503120012, 221503120013, 221503120014, 221503120015, 221503120016, 221503120017, 221503120018, 221503120019, 221503120020); Lot No. 62976480 (Serial Numbers: 221503190001, 221503190002, 221503190003, 221503190004, 221503190005, 221503190006, 221503190007, 221503190008, 221503190009, 221503190010, 221503190011, 221503190012, 221503190013, 221503190014, 221503190015, 221503190016, 221503190017, 221503190018, 221503190019, 221503190020); Lot No. 62976481 (Serial Numbers: 221503250001, 221503250002, 221503250003, 221503250004, 221503250005, 221503250006, 221503250007, 221503250008, 221503250009, 221503250010, 221503250011, 221503250012, 221503250013, 221503250014, 221503250015, 221503250016, 221503250017, 221503250018, 221503250019, 221503250020); Lot No. 63026460 (Serial Numbers: 221503270001, 221503270002, 221503270003, 221503270004, 221503270005); Lot No. 63007852 (Serial Numbers: 221504080001, 221504080002, 221504080003, 221504080004, 221504080005, 221504080006, 221504080007, 221504080008, 221504080009, 221504080010, 221504080011, 221504080012, 221504080013, 221504080014, 221504080015, 221504080016, 221504080017, 221504080018, 221504080019, 221504080020 Lot No. 63042181 (Serial Numbers: 221504140001, 221504140002, 221504140003, 221504140004, 221504140005); Lot No. 63042182 (Serial Numbers: 221504140006, 221504140007, 221504140008, 221504140009, 221504140010); Lot No. 63007853 (Serial Numbers: 221504140011, 221504140012, 221504140013, 221504140014, 221504140015, 221504140016, 221504140017, 221504140018, 221504140019, 221504140020, 221504140021, 221504140022, 221504140023, 221504140024, 221504140025, 221504140026, 221504140027, 221504140028, 221504140029, 221504140030); Lot No. 63042179 (Serial Numbers: 221504160001, 221504160002, 221504160003); Lot No. 63042184 (Serial Numbers: 221504220001, 221504220002, 221504220003, 221504220004, 221504220005); Lot No. 63037252 (Serial Numbers: 221504250001, 221504250002, 221504250003, 221504250004, 221504250005, 221504250006, 221504250007, 221504250008, 221504250009, 221504250010, 221504250011, 221504250012, 221504250013, 221504250014, 221504250015, 221504250016, 221504250017, 221504250018, 221504250019, 221504250020); Lot No. 63042180 (Serial Numbers: 221504280001, 221504280002, 221504280003, 221504280004, 221504280005, 221504280006, 221504280007, 221504280008, 221504280009, 221504280010, 221504280011, 221504280012, 221504280013, 221504280014, 221504280015, 221504280016, 221504280017, 221504280018, 221504280019, 221504280020); Lot No. 63042183 (Serial Numbers: 221505110001, 221505110002, 221505110003, 221505110004, 221505110005); Lot No. 63037254 (Serial Numbers: 221505120001, 221505120002, 221505120003, 221505120004, 221505120005, 221505120006, 221505120007, 221505120008, 221505120009, 221505120010, 221505120011, 221505120012, 221505120013, 221505120014, 221505120015, 221505120016, 221505120017, 221505120018, 221505120019, 221505120020); Lot No. 63092209 (Serial Numbers: 221506030001, 221506030002, 221506030003); Lot No. 63092210 (Serial Numbers: 221506050001, 221506050002, 221506050003, 221506050004, 221506050005); Lot No. 63072301 (Serial Numbers: 221506100001, 221506100002, 221506100003, 221506100004, 221506100005, 221506100006, 221506100007, 221506100008, 221506100009, 221506100010, 221506100011, 221506100012, 221506100013, 221506100014, 221506100015, 221506100016, 221506100017, 221506100018, 221506100019, 221506100020); Lot No. 63103587 (Serial Numbers: 221506130001, 221506130002, 221506130003, 221506130004, 221506130005, 221506130006, 221506130007, 221506130008, 221506130009, 221506130010, 221506130011, 221506130012, 221506130013, 221506130014, 221506130015); Lot No. 63072324 (Serial Numbers: 221506170001, 221506170002, 221506170003, 221506170004, 221506170005, 221506170006, 221506170007, 221506170008, 221506170009, 221506170010, 221506170011, 221506170012, 221506170013, 221506170014, 221506170015, 221506170016, 221506170017, 221506170018, 221506170019, 221506170020); Lot No. 63103164 (Serial Numbers: 221506170021, 221506170022, 221506170023); Lot No. 63072352 (Serial Numbers: 221506200001, 221506200002, 221506200003, 221506200004, 221506200005, 221506200006, 221506200007, 221506200008, 221506200009, 221506200010, 221506200011, 221506200012, 221506200013, 221506200014, 221506200015, 221506200016, 221506200017, 221506200018, 221506200019, 221506200020); Lot No. 63096468 (Serial Numbers: 221507150001, 221507150002, 221507150003, 221507150004, 221507150005, 221507150006, 221507150007, 221507150008, 221507150009, 221507150010, 221507150011, 221507150012, 221507150013, 221507150014, 221507150015, 221507150016, 221507150017, 221507150018, 221507150019, 221507150020); Lot No. 63109655 (Serial Numbers: 221507160001, 221507160002, 221507160003); Lot No. 63103590 (Serial Numbers: 221507210001, 221507210002, 221507210003, 221507210004, 221507210005, 221507210006, 221507210007, 221507210008, 221507210009, 221507210010, 221507210011, 221507210012, 221507210013, 221507210014, 221507210015); Lot No. 63109651 (Serial Numbers: 221507280001, 221507280002, 221507280003, 221507280004, 221507280005, 221507280006, 221507280007, 221507280008, 221507280009, 221507280010); Lot No. 63116357 (Serial Numbers: 221507290001, 221507290002, 221507290003, 221507290004, 221507290005, 221507290006, 221507290007, 221507290008, 221507290009, 221507290010, 221507290011, 221507290012, 221507290013, 221507290014, 221507290015, 221507290016, 221507290017, 221507290018, 221507290019, 221507290020); Lot No. 63123305 (Serial Numbers: 221508040001, 221508040002, 221508040003, 221508040004, 221508040005, 221508040006, 221508040007, 221508040008, 221508040009, 221508040010, 221508040011, 221508040012, 221508040013, 221508040014, 221508040015, 221508040016, 221508040017, 221508040018, 221508040019, 221508040020); Lot No. 63138553 (Serial Numbers: 221508260001, 221508260002, 221508260003, 221508260004, 221508260005, 221508260006, 221508260007, 221508260008, 221508260009, 221508260010, 221508260011, 221508260012, 221508260013, 221508260014, 221508260015, 221508260016, 221508260017, 221508260018, 221508260019, 221508260020); Lot No. 63138631 (Serial Numbers: 221509090001, 221509090002, 221509090003, 221509090004, 221509090005, 221509090006, 221509090007, 221509090008, 221509090009, 221509090010, 221509090011, 221509090012, 221509090013, 221509090014, 221509090015, 221509090016, 221509090017, 221509090018, 221509090019, 221509090020); Lot No. 63171089 (Serial Numbers: 221509240001, 221509240002, 221509240003, 221509240004, 221509240005, 221509240006, 221509240007, 221509240008, 221509240009, 221509240010, 221509240011, 221509240012, 221509240013, 221509240014, 221509240015, 221509240016, 221509240017, 221509240018, 221509240019, 221509240020); Lot No. 63202480 (Serial Numbers: 221510120001, 221510120002, 221510120003, 221510120004, 221510120005); Lot No. 63202478 (Serial Numbers: 221510220001, 221510220002, 221510220003, 221510220004, 221510220005, 221510220006, 221510220007, 221510220008, 221510220009, 221510220010, 221510220011, 221510220012, 221510220013, 221510220014, 221510220015, 221510220016, 221510220017, 221510220018, 221510220019, 221510220020); Lot No. 63234563 (Serial Numbers: 221511230001, 221511230002, 221511230003, 221511230004, 221511230005); Lot No. 63234565 (Serial Numbers: 221512020001, 221512020002, 221512020003, 221512020004, 221512020005); Lot No. 63212407 (Serial Numbers: 221512070001, 221512070002, 221512070003, 221512070004, 221512070005, 221512070006, 221512070007, 221512070008, 221512070009, 221512070010, 221512070011, 221512070012, 221512070013, 221512070014, 221512070015, 221512070016, 221512070017, 221512070018, 221512070019, 221512070020); Lot No. 63245752 (Serial Numbers: 221512160001, 221512160002, 221512160003, 221512160004, 221512160005, 221512160006, 221512160007); Lot No. 63253256 (Serial Numbers: 221512180001, 221512180002, 221512180003, 221512180004, 221512180005); Lot No. 63247425 (Serial Numbers: 221601060001, 221601060002, 221601060003, 221601060004, 221601060005, 221601060006, 221601060007, 221601060008, 221601060009, 221601060010, 221601060011, 221601060012, 221601060013, 221601060014, 221601060015, 221601060016, 221601060017, 221601060018, 221601060019, 221601060020); Lot No. 63526287 (Serial Numbers: 221612140001, 221612140002, 221612140003, 221612140004, 221612140005, 221612140006, 221612140007, 221612140008, 221612140009, 221612140010, 221612140011, 221612140012, 221612140013, 221612140014, 221612140015, 221612140016, 221612140017, 221612140018, 221612140019, 221612140020); Lot No. 63531691 (Serial Numbers: 221612150001, 221612150002, 221612150003, 221612150004, 221612150005, 221612150006, 221612150007); Lot No. 63526321 (Serial Numbers: 221612170001, 221612170002, 221612170003, 221612170004, 221612170005, 221612170006, 221612170007, 221612170008, 221612170009, 221612170010, 221612170011, 221612170012, 221612170013, 221612170014, 221612170015, 221612170016, 221612170017, 221612170018, 221612170019, 221612170020); Lot No. 63261584 (Serial Numbers: 221601070001, 221601070002, 221601070003, 221601070004, 221601070005); Lot No. 63264374 (Serial Numbers: 221601110001, 221601110002, 221601110003, 221601110004, 221601110005, 221601110006, 221601110007, 221601110008, 221601110009, 221601110010, 221601110011, 221601110012, 221601110013, 221601110014, 221601110015, 221601110016, 221601110017, 221601110018, 221601110019, 221601110020); Lot No. 63265280 (Serial Numbers: 221601140001, 221601140002, 221601140003, 221601140004, 221601140005, 221601140006, 221601140007); Lot No. 63257987 (Serial Numbers: 221601180001, 221601180002, 221601180003, 221601180004, 221601180005, 221601180006, 221601180007, 221601180008, 221601180009, 221601180010, 221601180011, 221601180012, 221601180013, 221601180014, 221601180015, 221601180016, 221601180017, 221601180018, 221601180019, 221601180020); Lot No. 63271202 (Serial Numbers: 221601220001, 221601220002, 221601220003, 221601220004, 221601220005); Lot No. 63258039 (Serial Numbers: 221602060001, 221602060002, 221602060003, 221602060004, 221602060005, 221602060006, 221602060007, 221602060008, 221602060009, 221602060010, 221602060011, 221602060012, 221602060013, 221602060014, 221602060015, 221602060016, 221602060017, 221602060018, 221602060019, 221602060020); Lot No. 63278388 (Serial Numbers: 221602150001, 221602150002, 221602150003, 221602150004, 221602150005, 221602150006, 221602150007, 221602150008, 221602150009, 221602150010, 221602150011, 221602150012, 221602150013, 221602150014, 221602150015, 221602150016, 221602150017, 221602150018, 221602150019, 221602150020); Lot No. 63278436 (Serial Numbers: 221602240001, 221602240002, 221602240003, 221602240004, 221602240005, 221602240006, 221602240007, 221602240008, 221602240009, 221602240010, 221602240011, 221602240012, 221602240013, 221602240014, 221602240015, 221602240016, 221602240017, 221602240018, 221602240019, 221602240020); Lot No. 63314121 (Serial Numbers: 221603090001, 221603090002, 221603090003); Lot No. 63314118 (Serial Numbers: 221603110001, 221603110002, 221603110003); Lot No. 63324625 (Serial Numbers: 221603220001, 221603220002, 221603220003); Lot No. 63336959 (Serial Numbers: 221603300001, 221603300002, 221603300003, 221603300004, 221603300005, 221603300006, 221603300007, 221603300008, 221603300009, 221603300010); Lot No. 63314042 (Serial Numbers: 221603300011, 221603300012, 221603300013, 221603300014, 221603300015, 221603300016, 221603300017, 221603300018, 221603300019, 221603300020, 221603300021, 221603300022, 221603300023, 221603300024, 221603300025, 221603300026, 221603300027, 221603300028, 221603300029, 221603300030); Lot No. 63341344 (Serial Numbers: 221604040001, 221604040002, 221604040003, 221604040004, 221604040005); Lot No. 63341346 (Serial Numbers: 221604050001, 221604050002, 221604050003, 221604050004, 221604050005, 221604050006, 221604050007, 221604050008, 221604050009, 221604050010); Lot No. 63314117 (Serial Numbers: 221604220001, 221604220002, 221604220003, 221604220004, 221604220005, 221604220006, 221604220007, 221604220008, 221604220009, 221604220010, 221604220011, 221604220012, 221604220013, 221604220014, 221604220015, 221604220016, 221604220017, 221604220018, 221604220019, 221604220020); Lot No. 63352349 (Serial Numbers: 221604250001, 221604250002, 221604250003); Lot No. 63339440 (Serial Numbers: 221605020001, 221605020002, 221605020003, 221605020004, 221605020005, 221605020006, 221605020007, 221605020008, 221605020009, 221605020010, 221605020011, 221605020012, 221605020013, 221605020014, 221605020015, 221605020016, 221605020017, 221605020018, 221605020019, 221605020020); Lot No. 63343366 (Serial Numbers: 221605060001, 221605060002, 221605060003, 221605060004, 221605060005, 221605060006, 221605060007, 221605060008, 221605060009, 221605060010, 221605060011, 221605060012, 221605060013, 221605060014, 221605060015, 221605060016, 221605060017, 221605060018, 221605060019, 221605060020, 221605060021, 221605060022); Lot No. 63352347 (Serial Numbers: 221605110001, 221605110002, 221605110003, 221605110004, 221605110005); Lot No. 63339497 (Serial Numbers: 221605120001, 221605120002, 221605120003, 221605120004, 221605120005, 221605120006, 221605120007, 221605120008, 221605120009, 221605120010, 221605120011, 221605120012, 221605120013, 221605120014, 221605120015, 221605120016, 221605120017, 221605120018, 221605120019, 221605120020); Lot No. 63378855 (Serial Numbers: 221606020001, 221606020002, 221606020003); Lot No. 63369605 (Serial Numbers: 221606110001, 221606110002, 221606110003, 221606110004, 221606110005, 221606110006, 221606110007, 221606110008, 221606110009, 221606110010, 221606110011, 221606110012, 221606110013, 221606110014, 221606110015, 221606110016, 221606110017, 221606110018, 221606110019, 221606110020); Lot No. 63403010 (Serial Numbers: 221606110021, 221606110022, 221606110023); Lot No. 63403012 (Serial Numbers: 221606150001, 221606150002, 221606150003, 221606150004, 221606150005, 221606150006, 221606150007, 221606150008); Lot No. 63403026 (Serial Numbers: 221606210001, 221606210002, 221606210003, 221606210004, 221606210005, 221606210006, 221606210007, 221606210008, 221606210009, 221606210010, 221606210011, 221606210012, 221606210013, 221606210014, 221606210015, 221606210016, 221606210017, 221606210018, 221606210019, 221606210020); Lot No. 63403009 (Serial Numbers: 221606220001, 221606220002, 221606220003); Lot No. 63403024 (Serial Numbers: 221606230001, 221606230002, 221606230003, 221606230004, 221606230005, 221606230006, 221606230007, 221606230008, 221606230009, 221606230010, 221606230011, 221606230012, 221606230013, 221606230014, 221606230015, 221606230016, 221606230017, 221606230018, 221606230019, 221606230020); Lot No. 63403025 (Serial Numbers: 221606240001, 221606240002, 221606240003, 221606240004, 221606240005, 221606240006, 221606240007, 221606240008, 221606240009, 221606240010); Lot No. 63403017 (Serial Numbers: 221606240011, 221606240012, 221606240013, 221606240014, 221606240015); Lot No. 63394148 (Serial Numbers: 221606290001, 221606290002, 221606290003, 221606290004, 221606290005, 221606290006, 221606290007, 221606290008, 221606290009, 221606290010, 221606290011, 221606290012, 221606290013, 221606290014, 221606290015, 221606290016, 221606290017, 221606290018, 221606290019, 221606290020); Lot No. 63410582 (Serial Numbers: 221607050001, 221607050002, 221607050003, 221607050004, 221607050005, 221607050006, 221607050007, 221607050008, 221607050009, 221607050010, 221607050011, 221607050012, 221607050013, 221607050014, 221607050015); Lot No. 63422767 (Serial Numbers: 221607080001, 221607080002, 221607080003, 221607080004, 221607080005, 221607080006, 221607080007, 221607080008, 221607080009, 221607080010, 221607080011, 221607080012, 221607080013, 221607080014, 221607080015, 221607080016, 221607080017, 221607080018, 221607080019, 221607080020); Lot No. 63410583 (Serial Numbers: 221607210001, 221607210002, 221607210003, 221607210004, 221607210005, 221607210006, 221607210007, 221607210008, 221607210009, 221607210010); Lot No. 63410585 (Serial Numbers: 221607220001, 221607220002, 221607220003, 221607220004, 221607220005, 221607220006, 221607220007, 221607220008, 221607220009, 221607220010); Lot No. 63394176 (Serial Numbers: 221607260001, 221607260002, 221607260003, 221607260004, 221607260005, 221607260006, 221607260007, 221607260008, 221607260009, 221607260010, 221607260011, 221607260012, 221607260013, 221607260014, 221607260015, 221607260016, 221607260017, 221607260018, 221607260019, 221607260020); Lot No. 63430499 (Serial Numbers: 221608080001, 221608080002, 221608080003, 221608080004, 221608080005, 221608080006, 221608080007, 221608080008, 221608080009, 221608080010, 221608080011, 221608080012, 221608080013, 221608080014, 221608080015, 221608080016, 221608080017, 221608080018, 221608080019, 221608080020); Lot No. 63437710 (Serial Numbers: 221608120001, 221608120002, 221608120003, 221608120004, 221608120005); Lot No. 63436338 (Serial Numbers: 221608160001, 221608160002, 221608160003, 221608160004, 221608160005); Lot No. 63445193 (Serial Numbers: 221608170001, 221608170002, 221608170003, 221608170004, 221608170005, 221608170006, 221608170007, 221608170008, 221608170009, 221608170010, 221608170011, 221608170012, 221608170013, 221608170014, 221608170015, 221608170016, 221608170017, 221608170018, 221608170019, 221608170020); Lot No. 63430540 (Serial Numbers: 221608190001, 221608190002, 221608190003, 221608190004, 221608190005, 221608190006, 221608190007, 221608190008, 221608190009, 221608190010, 221608190011, 221608190012, 221608190013, 221608190014, 221608190015, 221608190016, 221608190017, 221608190018, 221608190019, 221608190020); Lot No. 63445194 (Serial Numbers: 221608230001, 221608230002, 221608230003, 221608230004, 221608230005, 221608230006, 221608230007, 221608230008, 221608230009, 221608230010, 221608230011, 221608230012, 221608230013, 221608230014, 221608230015, 221608230016, 221608230017, 221608230018, 221608230019, 221608230020); Lot No. 63455066 (Serial Numbers: 221609010001, 221609010002, 221609010003, 221609010004, 221609010005, 221609010006, 221609010007, 221609010008, 221609010009, 221609010010, 221609010011, 221609010012, 221609010013, 221609010014, 221609010015, 221609010016, 221609010017, 221609010018, 221609010019, 221609010020); Lot No. 63474281 (Serial Numbers: 221609080001, 221609080002, 221609080003, 221609080004, 221609080005, 221609080006, 221609080007, 221609080008, 221609080009, 221609080010, 221609080011, 221609080012, 221609080013, 221609080014, 221609080015, 221609080016, 221609080017, 221609080018, 221609080019, 221609080020); Lot No. 63474283 (Serial Numbers: 221609080021, 221609080022, 221609080023, 221609080024, 221609080025, 221609080026); Lot No. 63474284 (Serial Numbers: 221609150001, 221609150002, 221609150003, 221609150004, 221609150005, 221609150006, 221609150007, 221609150008); Lot No. 63474287 (Serial Numbers: 221609210001, 221609210002, 221609210003, 221609210004, 221609210005, 221609210006, 221609210007, 221609210008, 221609210009, 221609210010); Lot No. 63474285 (Serial Numbers: 221610010001, 221610010002, 221610010003, 221610010004, 221610010005, 221610010006, 221610010007, 221610010008, 221610010009, 221610010010, 221610010011, 221610010012, 221610010013, 221610010014, 221610010015); Lot No. 63455098 (Serial Numbers: 221610050001, 221610050002, 221610050003, 221610050004, 221610050005, 221610050006, 221610050007, 221610050008, 221610050009, 221610050010, 221610050011, 221610050012, 221610050013, 221610050014, 221610050015, 221610050016, 221610050017, 221610050018, 221610050019, 221610050020); Lot No. 63474282 (Serial Numbers: 221610110001, 221610110002, 221610110003, 221610110004, 221610110005, 221610110006, 221610110007, 221610110008, 221610110009, 221610110010, 221610110011, 221610110012, 221610110013, 221610110014, 221610110015, 221610110016, 221610110017, 221610110018, 221610110019, 221610110020); Lot No. 63484747 (Serial Numbers: 221610140001, 221610140002, 221610140003, 221610140004, 221610140005); Lot No. 63482404 (Serial Numbers: 221610180001, 221610180002, 221610180003, 221610180004, 221610180005, 221610180006, 221610180007, 221610180008, 221610180009, 221610180010, 221610180011, 221610180012, 221610180013, 221610180014, 221610180015, 221610180016, 221610180017, 221610180018, 221610180019, 221610180020); Lot No. 63482405 (Serial Numbers: 221610200001, 221610200002, 221610200003, 221610200004, 221610200005, 221610200006, 221610200007, 221610200008, 221610200009, 221610200010, 221610200011, 221610200012, 221610200013, 221610200014, 221610200015, 221610200016, 221610200017, 221610200018, 221610200019, 221610200020); Lot No. 63482408 (Serial Numbers: 221611210001, 221611210002, 221611210003, 221611210004, 221611210005, 221611210006, 221611210007, 221611210008, 221611210009, 221611210010, 221611210011,221611210012, 221611210013, 221611210014, 221611210015, 221611210016, 221611210017, 221611210018, 221611210019, 221611210020); Lot No. 63501470 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501471 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501459 (Serial Numbers: 221611280001, 221611280002, 221611280003, 221611280004, 221611280005, 221611280006, 221611280007, 221611280008, 221611280009, 221611280010, 221611280011, 221611280012, 221611280013, 221611280014, 221611280015, 221611280016, 221611280017, 221611280018, 221611280019, 221611280020); Lot No. 63501486 (Serial Numbers: 221612020001, 221612020002, 221612020003, 221612020004, 221612020005, 221612020006, 221612020007, 221612020008, 221612020009, 221612020010, 221612020011, 221612020012, 221612020013, 221612020014, 221612020015, 221612020016, 221612020017, 221612020018, 221612020019, 221612020020); Lot No. 63501469 (Serial Numbers: 221612030001, 221612030002, 221612030003, 221612030004, 221612030005, 221612030006, 221612030007, 221612030008, 221612030009, 221612030010, 221612030011, 221612030012, 221612030013, 221612030014, 221612030015, 221612030016, 221612030017, 221612030018); Lot No. 63531693 (Serial Numbers: 221612050001, 221612050002, 221612050003, 221612050004, 221612050005); Lot No. 63501509 (Serial Numbers: 221612070001, 221612070002, 221612070003, 221612070004, 221612070005, 221612070006, 221612070007, 221612070008, 221612070009, 221612070010, 221612070011, 221612070012, 221612070013, 221612070014, 221612070015, 221612070016, 221612070017, 221612070018, 221612070019, 221612070020); Lot No. 63501547 (Serial Numbers: 221612100001, 221612100002, 221612100003, 221612100004, 221612100005, 221612100006, 221612100007, 221612100008, 221612100009, 221612100010, 221612100011, 221612100012, 221612100013, 221612100014, 221612100015, 221612100016, 221612100017, 221612100018, 221612100019, 221612100020); Lot No. 63501493 (Serial Numbers: 221612130001, 221612130002, 221612130003, 221612130004, 221612130005, 221612130006, 221612130007, 221612130008)", "center_classification_date": "20180214", "distribution_pattern": "Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..", "state": "OH", "product_description": "A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.", "report_date": "20180221", "classification": "Class II", "openfda": {}, "recalling_firm": "Zimmer Surgical Inc", "recall_number": "Z-0613-2018", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "78759", "termination_date": "20190801", "more_code_info": "", "recall_initiation_date": "20170727", "postal_code": "44622-9642", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }