{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "212926", "product_res_number": "Z-1513-2025", "event_date_initiated": "2025-03-07", "event_date_posted": "2025-04-03", "recall_status": "Open, Classified", "res_event_number": "96461", "product_code": "NEW", "k_numbers": [ "K183183" ], "product_description": "PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP", "code_info": "Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;", "firm_fei_number": "3005075853", "recalling_firm": "Ethicon Endo Surgery, LLC", "address_1": "475C - Suite 202 475C", "address_2": "Suite 202", "city": "Guaynabo", "postal_code": "00969", "country": "PR", "additional_info_contact": "Ethicon Resource Department\n1-877-384-4266", "reason_for_recall": "Identified curing issues with the silicone during the needles manufacturing process.", "root_cause_description": "Process control", "action": "On March 7, 2025, \"URGENT: MEDICAL DEVICE RECALL (REMOVAL)\"letters dated March 7, 2025, were sent to customers. ACTION REQUIRED\n1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records.\n2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. \n3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax 866-209-0985 or email ethicon8403@sedgwick.com to Sedgwick within three (3) business days. Please return the BRF even if you do not have product subject to this recall.\n4. Customers are required to immediately return all unused sutures subject to this recall that are in inventory no later than June 30, 2025, to Sedgwick. \n5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. \n6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick.\nIf you require any assistance with returning product, please contact Sedgwick at 866-737-4762 and reference Event # 8403.\n\nIf you have additional questions regarding this communication or want to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.", "product_quantity": "792 units", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.", "openfda": { "k_number": [ "K063680", "K080918", "K150553", "K192423", "K120827", "K191361", "K022666", "K030212", "K130191", "K080985", "K051609", "K212380", "K113004", "K100780", "K201139", "K061037", "K080680", "K030786", "K042285", "K031443", "K242571", "K232246", "K172602", "K141776", "K210871", "K242835", "K252644", "K251414", "K120284", "K240389", "K252171", "K190245", "K042075", "K261988", "K113744", "K150670", "K161737", "K162366", "K160705", "K133420", "K181582", "K013274", "K190264", "K081001", "K082097", "K143413", "K250107", "K160761", "K252047", "K250977", "K043298", "K192144", "K040004", "K073614", "K053380", "K100461", "K041048", "K123877", "K220549", "K123668", "K182873", "K071989", "K132268", "K031216", "K243897" ], "pma_number": [ "N18331" ], "registration_number": [ "", "3030733800", "3004845555", "3012494290", "3003828812", "1221601", "1054241", "3004944585", "3023274465", "3017936846", "3013403214", "2030624", "3006680097", "1000274611", "3015812758", "2528981", "3013557562", "3015138222", "3018052045", "1064584", "3016244792", "3014461810", "3014273254", "1721676", "1221934", "3016010820", "3003639970", "3008912461", "3016445763", "2650143", "3029901632", "3013376016", "3005953126", "2125050", "3010131137", "2648650", "3007895168", "3044819802", "3016904853", "3045855232", "3008868758", "3012421607", "3006638824", "3038138322", "3012502601", "3011689956", "3016560306", "1043214", "3002294946", "3027329031", "3010041511", "3006562124", "2183744", "3003267729", "2246552", "3010692967", "3004117249", "1018470", "3012438919", "3013187142", "3015289316", "3010462274", "3013354263", "3010864832", "3013589761", "3020983460", "2210968", "3014527910", "3014579161", "3007205024", "3043226252", "3014272734", "1055236", "3011137372", "1320468", "3013298431", "3017102971", "3014615644", "1614993", "3006981798", "3007791599", "3011555199", "3005972890", "9617547", "3004365956", "3013529787", "3008114965" ], "fei_number": [ "", "3030733800", "3004845555", "3012494290", "3003828812", "1221601", "3004944585", "3023274465", "3017936846", "3013403214", "3006680097", "1000274611", "3015812758", "2528981", "3013557562", "3005747797", "3015138222", "3018052045", "3016244792", "3014461810", "3014273254", "1721676", "1221934", "3016010820", "3003639970", "3008912461", "3016445763", "3029901632", "3013376016", "3005953126", "2125050", "3010131137", "2648650", "3007895168", "1000112877", "3044819802", "3016904853", "3045855232", "3008868758", "3012421607", "3003063934", "3006638824", "3038138322", "3012502601", "3011689956", "3016560306", "1043214", "3002294946", "3027329031", "3010041511", "3000206455", "3006562124", "2183744", "3003267729", "2246552", "3010692967", "3004117249", "1018470", "3012438919", "3013187142", "3015289316", "3010462274", "3013354263", "3013589761", "3020983460", "2210968", "3014527910", "3014579161", "3007205024", "3003272809", "3043226252", "3014272734", "1000112968", "2648209", "3010862763", "3013298431", "3017102971", "3014615644", "1614993", "3006981798", "3007791599", "3011555199", "3005972890", "3004365956", "3013529787", "3008114965", "3000206435" ], "device_name": "Suture, Surgical, Absorbable, Polydioxanone", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4840", "device_class": "2" } } ] }