FDA Device recall Z-0647-2025
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J by Medline Industries Northfield, citing medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0647-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D
Reason
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Identifiers
| code_info | 1) REF CDS985431J, UDI/DI 10195327336110 (each) 40195327336111 (case), Lot Numbers: 23BBG608; 2) REF CDS985431K, UDI…1) REF CDS985431J, UDI/DI 10195327336110 (each) 40195327336111 (case), Lot Numbers: 23BBG608; 2) REF CDS985431K, UDI/DI 10195327451295 (each) 40195327451296 (case), Lot Numbers: 23JBF512, 23IBQ647; 3) REF CDS985431L, UDI/DI 10195327527273 (each) 40195327527274 (case), Lot Numbers: 24ABA205, 24ABW239, 24ABV349, 24CBR704, 24EBP485; 4) REF DYNJ44153G, UDI/DI 10195327412623 (each) 40195327412624 (case), Lot Numbers: 23KBB932; 5) REF DYNJ60924C, UDI/DI 10195327470333 (each) 40195327470334 (case), Lot Numbers: 23JBF913; 6) REF DYNJVB1280C, UDI/DI 10195327173951 (each) 40195327173952 (case), Lot Numbers: 23ELB178, 23CLA196, 23BLA668, 23BLA272; 7) REF DYNJVB1280D, UDI/DI 10195327482114 (each) 40195327482115 (case), Lot Numbers: 24CLA257, 23LLA915, 24CLA715, 24BLA712; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0647-2025%22
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