FDA Device recall Z-1035-2019
Forceps Blue, disposable, sterile, 100 eaches per sales unit
- FDA Device
- Class II
- ongoing
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Forceps Blue, disposable, sterile, 100 eaches per sales unit by Convatec, citing an internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1035-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-09 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Convatec |
| Distribution | US |
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
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Identifiers
| code_info | Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231…Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1035-2019%22
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