Surgipro II Monofilament Polypropylene Sutures Product Description… — Class II medical device recall Z-1180-2023

Ongoing recall by Covidien, LP, reported 2023-03-08, distributed nationwide. Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases

Recall number	`Z-1180-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Covidien, LP, North Haven, CT, United States
Recall initiated	2022-12-02
Classified	2023-02-25
Reported by FDA	2023-03-08
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA
Quantity	322,152 units
Reason classes	sterility
UPC / GTIN / UDI-DI	`10884521037717`, `10884521037748`, `10884521038813`, `10884521038844`, `10884521038905`, `10884521038943`, `10884521039469`, `10884521039537`, `10884521039568`, `10884521039599`, `10884521640061`, `10884521640276`, `20884521037714`, `20884521037745`, `20884521037844`, `20884521037851`, `20884521038810`, `20884521038841`, `20884521038896`, `20884521038902`, `20884521038940`, `20884521039404`, `20884521039466`, `20884521039534`, `20884521039565` and 3 more
Lot numbers	`D0K3052Y`, `D0M1980Y`, `D0M1981Y`, `D0M2060Y`, `D0M2061Y`, `D1A0234Y`, `D1A0419Y`, `D1A0420Y`, `D1A0474Y`, `D1A0479Y`, `D1A0480Y`, `D1A0499Y`, `D1A0960Y`, `D1A1236Y`, `D1A1238Y`, `D1A1240Y`, `D1A1242Y`, `D1A1244Y`, `D1A1526Y`, `D1A1635Y`, `D1A1636Y`, `D1B0024Y`, `D1B0513Y`, `D1B0657Y`, `D1B1245Y`, `D1B1246Y`, `D1B1265Y`, `D1B1462Y`, `D1B1954Y`, `D1B2137Y`, `D1B2688Y`, `D1B2759Y`, `D1B2760Y`, `D1B2784Y`, `D1B2785Y`, `D1C0229Y`, `D1C0230Y`, `D1C0681Y`, `D1C1118Y`, `D1C1270Y` and 279 more
Model numbers	`4-0`, `90CM`, `D0K3052Y`, `D0M1980Y`, `D0M1981Y`, `D0M2060Y`, `D0M2061Y`, `D1A0234Y`, `D1A0419Y`, `D1A0420Y`, `D1A0474Y`, `D1A0479Y`, `D1A0480Y`, `D1A0499Y`, `D1A0960Y`, `D1A1236Y`, `D1A1238Y`, `D1A1240Y`, `D1A1242Y`, `D1A1244Y`, `D1A1526Y`, `D1A1635Y`, `D1A1636Y`, `D1B0024Y`, `D1B0513Y` and 300 more

Product

Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X SURGIPRO*II 7-0 60CM MV1758DA VP735X VP735X-12 SURGIPRO*II 7-0 60CM MV1758 DA VP735X12 VP-738-X SURGIPRO*II 8-0BLU 60CM CV351DA VP738X VP-744-X SURGIPRO*II 8-0 45CM MV1758DA VP744X VP-745-X SURGIPRO*II 8-0 60CM MV1758DA VP745X VP-747-X SURGIPRO*II 7-0 75CM MV1758DA VP747X VP-853 SURGIPRO* 2-0 BLU 120CM V26 DA VP853 VP-875-X SURGIPRO*II 7-0 75CM MV1759DA VP875X VP-900-X SURGIPRO*II 8-0 45CM MV1355DA VP900X VP-902-X SURGIPRO*II 8-0 60CM MV1355DA VP902X VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X SURGIPRO*II 7-0 60CM MV1758DA VP735X VP735X-12 SURGIPRO*II 7-0 60CM MV1758 DA VP735X12 VP-738-X SURGIPRO*II 8-0BLU 60CM CV351DA VP738X VP-744-X SURGIPRO*II 8-0 45CM MV1758DA VP744X VP-745-X SURGIPRO*II 8-0 60CM MV1758DA VP745X VP-747-X SURGIPRO*II 7-0 75CM MV1758DA VP747X VP-853 SURGIPRO* 2-0 BLU 120CM V26 DA VP853 VP-875-X SURGIPRO*II 7-0 75CM MV1759DA VP875X VP-900-X SURGIPRO*II 8-0 45CM MV1355DA VP900X VP-902-X SURGIPRO*II 8-0 60CM MV1355DA VP902X12 VP-904-X SURGIPRO*II 7-0 BLU 60CM MV1355 VP904X VPF-735-X SURGIPRO*II 7-0 60CM MVF1758DA VPF735X XX-3300 SURGIPRO* II 5-0 BLU 60CM CV1DA XX3300 XX-5224 SURGIPRO*II 5-0 BLU 90CM CV25DA XX5224

Reason for recall

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1180-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.