Sterile Custom Packs to be used in surgical procedures — Class II medical device recall Z-2170-2020
Terminated recall by American Contract Systems, reported 2020-06-10, distributed nationwide. The surgical gowns were manufactured in a facility that is not registered by the FDA.
| Recall number | Z-2170-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems, Zelienople, PA, United States |
| Recall initiated | 2020-04-13 |
| Classified | 2020-05-29 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2020-11-25 |
| Distributed | Nationwide (US) |
| Quantity | 2,868 kits |
| Lot numbers | 639191, 642191, 643191, 650191, 654191, 656191, 670191, 671191, 675191, 71891, 723191, 789191, 997201 |
| Expiration dates | 2020-07-30, 2020-10-04, 2020-10-09, 2020-11-21, 2020-11-25, 2020-11-26, 2020-12-10, 2020-12-12, 2020-12-16, 2020-12-23, 2020-12-24, 2020-12-27, 2021-01-03 |
Product
Sterile Custom Packs to be used in surgical procedures.
Reason for recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
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-2170-2020. 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.