Forceps Blue — Class II medical device recall Z-1035-2019
Ongoing recall by ConvaTec, Inc, reported 2019-03-27, distributed nationwide. An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
| Recall number | Z-1035-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2019-01-09 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IL, IS, IT, KE, KR, KW, LB, NL, NO, NZ, PL, QA, SE, SG, SK, TR, VN, ZA |
| Quantity | 24,822,068 devices |
| Reason classes | sterility |
| Lot numbers | 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969 |
| Model numbers | 417389 |
Product
Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.
Reason for recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
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-1035-2019. 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.