PS-500 Scope Warmer — Class II medical device recall Z-0732-2016
Terminated recall by JosNoe Medical, Inc., reported 2016-02-10, distributed nationwide. Damage to package seals potentially compromising sterility.
| Recall number | Z-0732-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | JosNoe Medical, Inc., Chelsea, MI, United States |
| Recall initiated | 2015-12-01 |
| Classified | 2016-01-30 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,008 boxes |
| Reason classes | sterility |
| Lot numbers | G154341 |
| Expiration dates | 2018-04-14 |
Product
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Reason for recall
Damage to package seals potentially compromising sterility.
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-0732-2016. 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.