SHARP MEDICAL PRODUCTS — Class II medical device recall Z-1366-2021
Terminated recall by Sharp Medical Products, reported 2021-04-14, distributed in AZ, FL, MI, OH, TX, WI. Non-conformity (holes/punctures or deep creases) in the sterile barrier.
| Recall number | Z-1366-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sharp Medical Products, Scottsdale, AZ, United States |
| Recall initiated | 2021-02-08 |
| Classified | 2021-04-06 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2023-02-17 |
| Distributed | AZ, FL, MI, OH, TX, WI |
| Reason classes | sterility |
| Lot numbers | 0818-009 |
| Model numbers | 100-36-01 |
Product
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Reason for recall
Non-conformity (holes/punctures or deep creases) 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-1366-2021. 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.