Medline brand — Class II medical device recall Z-0723-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-01, distributed nationwide. Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-th
| Recall number | Z-0723-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-11-06 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489665734, 10193489995558, 10195327163976, 10195327332143, 10195327368821, 10195327556471, 10195327560829, 10195327576233, 10195327618681, 10195327635466, 10195327635480, 10195327660420, 10198459011245, 10198459059353, 10198459064531, 10198459111723, 10198459122910, 10889942885534, 40193489665735, 40193489995559, 40195327163977, 40195327332144, 40195327368822, 40195327556472, 40195327560820 and 11 more |
| Lot numbers | 20EBU633, 20HBC730, 20HBU423, 20IBI973, 20JBB045, 20KBB297, 21GBO771, 21IBN569, 21KBA966, 21LBB957, 22EMA026, 22FLA458, 22FLB055, 22FMB386, 23GMA619, 23GME971, 23HLA314, 23KMD713, 23LMG055, 24ABO420, 24ABO451, 24ABW268, 24BBK513, 24BBK920, 24BBN342, 24BBO346, 24BMJ118, 24CBV435, 24CMA496, 24DBO636, 24EMD223, 24EMH357, 24FBF951, 24FBL017, 24FBN697, 24FMD601, 24GBK331, 24GBQ357, 24GBR460, 24GMA069 and 18 more |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0723-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.