FDA Device recall Z-1090-2023
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
- FDA Device
- Class II
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class II recall of Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY by Medline Industries Northfield, citing sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1090-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-17 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
Reason
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Identifiers
| code_info | a. PELVISCOPY PACK, Item Number: DYNJ82555, Case UDI/GTIN: 40195327198252, Unit UDI/GTIN: 10195327198251, Lot Number: 2…a. PELVISCOPY PACK, Item Number: DYNJ82555, Case UDI/GTIN: 40195327198252, Unit UDI/GTIN: 10195327198251, Lot Number: 22HBQ035; b. D-PELVISCOPY, Item Number: DYNJ900628I, Case UDI/GTIN: 40195327224142, Unit UDI/GTIN: 10195327224141, Lot Number: 22JDB340; |
|---|
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-1090-2023%22
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