FDA Device recall Z-0723-2025
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X by Medline Industries Northfield, citing surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0723-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-06 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UNIVERSAL NEURO PACK, SKU DYNJ84496A; 12) SPINE PACK LF, SKU DYNJ85830; 13) AHT SPINE PACK, SKU DYNJ903566D; 14) LAMINECTOMY SPINAL FUSION PACK, SKU DYNJ909364A; 15) DIEP, SKU DYNJ909472; 16) AMBULATORY SINUS, SKU DYNJ910292; 17) AMBULATORY SINUS, SKU DYNJ910292A
Reason
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Identifiers
| code_info | UDI-DI: CDS982719X, 10198459064531 (each), 40198459064532 (case), Lot Numbers: 24IBE288; UDI-DI: DYNJ21927Q, 1088994288…UDI-DI: CDS982719X, 10198459064531 (each), 40198459064532 (case), Lot Numbers: 24IBE288; UDI-DI: DYNJ21927Q, 10889942885534 (each), 40889942885535 (case), Lot Numbers: 21LBB957 21KBA966 21IBN569 21GBO771 20KBB297 20JBB045 20IBI973 20HBU423 20HBC730 20EBU633; UDI-DI: DYNJ21927S, 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24GBQ357 24GBK331 24FBF951 24CBV435 24BBN342 24ABW268; UDI-DI: DYNJ61607A, 10193489665734 (each), 40193489665735 (case), Lot Numbers: 22FLB055 22FLA458; UDI-DI: DYNJ66419C, 10198459059353 (each), 40198459059354 (case), Lot Numbers: 24IBG439; UDI-DI: DYNJ69907, 10193489995558 (each), 40193489995559 (case), Lot Numbers: 22EMA026; UDI-DI: DYNJ69907A, 10195327163976 (each), 40195327163977 (case), Lot Numbers: 22FMB386; UDI-DI: DYNJ81934B, 10198459122910 (each), 40198459122911 (case), Lot Numbers: 24IBG522; UDI-DI: DYNJ82007A, 10195327635466 (each), 40195327635467 (case), Lot Numbers: 24IME319 24HMI978 24HMI081 24CMA496; UDI-DI: DYNJ82011A, 10195327635480 (ea |
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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-0723-2025%22
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