FDA Device recall Z-1037-2022
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack by American Contract Systems, citing product was sterilized with a higher than specification EO concentration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1037-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-22 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Reason
Product was sterilized with a higher than specification EO concentration.
Identifiers
| code_info | 1) ACS Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; U…1) ACS Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T, Lot 966221, UDI: 00191072149954 |
|---|
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-1037-2022%22
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