FDA Device recall Z-1093-2023
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH V…
- 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. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH V… 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-1093-2023 |
| 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. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF
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. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IM…a. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IMD263; b. LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/GTIN: 10195327008697, Lot Number: 22JME637; c. TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/GTIN: 10193489651263, Lot Number: 22JBM626,22JBK303; d. CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/GTIN: 10195327164607, Lot Number: 22JBM359; e. LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/GTIN: 10193489413113, Lot Number: 22HBU206,22HBU964; f. GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/GTIN: 10195327143985, Lot Number: 22IBA054; g. MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/GTIN: 10193489899924, Lot Number: 22JBN433,22IBE548; h. MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 4019 |
|---|
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-1093-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.