FDA Device recall Z-1180-2023
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGI…
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGI… by Covidien, citing sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1180-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-02 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
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
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Identifiers
| code_info | GTIN: GTIN 20884521039534 20884521038902 20884521039596 20884521038810 10884521038813 20884521039565 10884521039568 208…GTIN: GTIN 20884521039534 20884521038902 20884521039596 20884521038810 10884521038813 20884521039565 10884521039568 20884521039466 10884521039469 10884521640061 20884521038940 10884521038943 20884521038841 20884521038896 10884521039599 10884521038905 10884521037717 20884521037714 10884521037748 20884521037745 10884521640276 20884521039404 20884521037844 20884521037851 20884521758558 20884521758664 10884521039537 10884521038844 Model Number Lot # VP421X D2C1147Y VP435X D2C1148Y D2D0080Y D2D0081Y D2D1507Y D2E1343Y VP541X D2E0506Y D2E0507Y VP542X D2E0749Y D2E0750Y VP735X D0M2060Y D0M2061Y D1A0234Y D1A0419Y D1A0420Y D1A0474Y D1A0479Y D1A0480Y D1A0499Y D1A0960Y D1A1636Y D1B0024Y D1B0513Y D1B1462Y D1B2759Y D1B2760Y D1B2784Y D1B2785Y D1G2405Y D1G2406Y D1H1658Y D1H1945Y D1H1971Y D1H2033Y D1H2104Y D1H2105Y D1H2106Y D1H2107Y D1J0372Y D1J0374Y D1J0375Y D1J0376Y D1J0591Y D1J1260Y D1J1679Y D1J1923Y D1J1928Y D1J1929Y D1J2885Y D1K2644Y D1L0457Y D1L3332 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1180-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.