{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "186810", "product_res_number": "Z-1490-2021", "event_date_initiated": "2021-04-15", "event_date_created": "2021-04-23", "recall_status": "Open, Classified", "res_event_number": "87709", "product_code": "KOH", "product_description": "Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure.\n\nMaterial No. M0068318210", "code_info": "All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221  GTIN 08714729848097", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Rebecca Kinkead Rubio\n508-683-4000", "reason_for_recall": "Potential for pinholes (sterile barrier breach)\non the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection", "root_cause_description": "Packaging process control", "action": "Boston Scientific issued Urgent Medical Device Product Removal on 4/15/21 via FedX. Letter states reason for recall, health risk and action to take; Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal.\nThis removal affects only the UPNs and batches listed below and in Attachment 1. No other UPNs or batches are impacted by this removal. Please cease further distribution or use of any remaining product affected by this removal immediately. \nIf you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions and indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning.\nBSC is notifying regulatory authorities of this removal as required.\nPlease read carefully through the removal instructions included with this notification. Your local Sales Representative can answer any questions that you may have regarding this notification.", "product_quantity": "4,549 WW", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan,\nBelgium, Lebanon, Mauritius, Mexico, Morocco, Namibia,\nNetherlands, New Zealand, Norway, Panama, Poland, Portugal,\nPuerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain,\nSweden, Switzerland, Taiwan.", "openfda": { "k_number": [ "K921732", "K780460", "K790851", "K891049", "K800834", "K812204", "K891351", "K781767", "K840308", "K921730", "K823792", "K000212", "K891035", "K863610", "K892693" ], "registration_number": [ "3008496560", "3009703496", "3007648354", "9710524", "3008843439", "3010041511", "2246552", "3005067367", "3043007473", "8010099", "1450908", "3005595283", "9611274", "2434839", "9611112", "3004519921", "3006210673", "1421879", "8030607", "9610612", "3002807314", "8040233", "3009340886", "1836161", "8010298", "1225580", "3011137372", "3007137643", "5906", "3009513193", "3013503739", "3003877407", "1056350", "3006554912", "9611273", "3003431869", "3015173212", "8043496", "3032747418", "2020550", "1416666", "3005440795", "8010257", "3014902417", "2916714", "3005092287", "3009865268", "1216677", "1422634", "9612074", "3010202439", "3005099803", "8043769", "3013846070", "8040278", "3013055490", "3008388245", "3014342096", "3008770252", "3014195785", "3004859928", "9615857", "1222773", "9610617", "1923569", "1926681", "2124215", "8040884", "8010370", "3007031059", "9680718", "3006546082", "3008403546", "2084346", "9680515", "3005813597", "9613083", "3045058049", "3007123908", "2125050", "2023739", "9616250", "3003644849", "3005273623" ], "fei_number": [ "3008496560", "3007475226", "3009703496", "3007648354", "3008843439", "5870", "3010041511", "3003448211", "2246552", "3043007473", "1450908", "3005969827", "3005595283", "3002808360", "2434839", "3006210673", "4417", "3004216008", "1000124817", "3002808043", "3002807314", "3009340886", "3002808268", "3002807072", "3002806315", "3000280067", "3546", "3007137643", "5906", "3009513193", "3005747797", "3013503739", "3003877407", "3006554912", "3003499455", "4498", "3005846326", "3003431869", "3015173212", "3003944071", "3008782585", "3032747418", "2020550", "3006509795", "1416666", "3005440795", "1000179044", "3002409980", "3374", "3002806486", "3002750084", "3014902417", "2916714", "3005092287", "3009865268", "1000514656", "1216677", "3005099803", "3012349753", "3013846070", "3013055490", "3008388245", "3014342096", "3008770252", "1000120768", "3003772581", "3014195785", "3004859928", "1000115048", "1923569", "1926681", "2124215", "3007031059", "1000140363", "3006546082", "3008403546", "3002807988", "3005813597", "3045058049", "2125050", "2023739", "3007123908", "3003644849", "3005273623" ], "device_name": "Instrument, Manual, General Obstetric-Gynecologic", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.4520", "device_class": "1" } } ] }