FDA Device recall Z-1366-2021
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
- FDA Device
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult by Sharp Medical Products, citing non-conformity (holes/punctures or deep creases) in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1366-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-08 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sharp Medical Products |
| Distribution | AZ, FL, MI, OH, TX, WI |
Product
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Reason
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Identifiers
| code_info | Catalogue Number: 100-36-01 Lot Number: 0818-009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1366-2021%22
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