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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific Corporation: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

Agency Publication Date: March 4, 2021
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Affected Products

Product: Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.

Outer box GTIN: 08714729019251 Inner pouch GTIN: 08714729747680 Lot/Batch#: 24725319, 24782695, Outer box GTIN: 08714729019312 Inner pouch GTIN: 08714729747833 Lot/Batch#: 24842597, 24812577, Outer box GTIN: 08714729019336 Inner pouch GTIN: 08714729747857 Lot/Batch#: 24889757, 24719202, 24709536, 24773287, Outer box GTIN: 08714729019350 Inner pouch GTIN: 08714729747871 Lot/Batch#: 24782693, 24732964, 24889755, 24780939, Outer box GTIN: 08714729071068 Inner pouch GTIN: 08714729747970 Lot/Batch#: 24882357, 24782689, 24782687, 24729758, Outer box GTIN: 08714729019411 Inner pouch GTIN:08714729747932 Lot/Batch#: 24961643 Outer box GTIN:08714729501640 Inner pouch GTIN: 08714729747932 Lot/Batch#: 24961645, 24989260, 24844193, Outer box GTIN:08714729501657 Inner pouch GTIN:08714729747956 Lot/Batch#: 25010054, Outer box GTIN:08714729019459 Inner pouch GTIN:08714729747994 Lot/Batch#: 25016793.

Lot Numbers:
24725319
24842597
24889757
24782693
24882357
24961643
24961645
25010054
25016793
Product: Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.

Outer box GTIN: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639 Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628 Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104 Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403 Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995

Lot Numbers:
25053639
24948407
24770325
24679614
24772995
Product: Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.

Outer box GTIN: 08714729283904 Inner pouch GTIN: 08714729747598 Lot/Batch#: 24818278, 24906823, 25042455 Outer box GTIN: 08714729283928 Inner pouch GTIN: 08714729747611 Lot/Batch#: 24685766, 24817145, 24899710, 24739786, 25006735, 24861901 Outer box GTIN: 08714729158110 Inner pouch GTIN: 08714729748069 Lot/Batch#: 24685764, 24890051, 24824132 Outer box GTIN: 08714729268802 Inner pouch GTIN: 08714729748069 Lot/Batch#: 25023345 Outer box GTIN: 08714729158141 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24699718, 24939626, 24861739 Outer box GTIN: 08714729268819 Inner pouch GTIN: 08714729748083 Lot/Batch#: 24824134, 25006729, 24709534 Outer box GTIN: 08714729501664 Inner pouch GTIN: 08714729748083 Lot/Batch#: 25023203, 24697822, 24739587, 24942292, 24909214, 24824136 Outer box GTIN: 08714729158158 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24856636, 24927642, 24699218 Outer box GTIN: 08714729268826 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24835709, 24818605, 25023343 Outer box GTIN: 08714729501671 Inner pouch GTIN: 08714729748106 Lot/Batch#: 24909216, 24758832, 24872119, 24994171, 25048397, 2475126, 24929431, 24995438

Lot Numbers:
24818278
24685766
24685764
25023345
24699718
24824134
25023203
24856636
24835709
24909216

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87221
Status: Active
Manufacturer: Boston Scientific Corporation
Manufactured In: United States
Units Affected: 3 products (335,788 units total (Domestic: 222,882, Foreign: 112,906))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.