Medline Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline recalls surgical patties and strips from specific kit lots due to higher-than-expected endotoxin levels. The 318 kits were distributed in the United States and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of sterile surgical devices with endotoxin contamination. No illnesses or injuries reported. Per the rubric, this represents a risk-of-harm product without reported injury, warranting High (3) severity.
Plain-English summary
Medline Industries is recalling 318 units of medical procedure convenience kits containing sterile Codman Surgical Patties and Strips. The affected products are labeled MVFF/FIBU #54-RF (SKU DYNJ21927R) and DIEP FLAP (SKU DYNJ910120A), with specific lot numbers including 23IBF547, 23GBT501, 23FBU360, 23EBU929, 23EBL624, 23EBA114, 23CBN730, 23ABF393, 22JBK203, 22IBN858, 22HBO301, 22GBC794, 22CBI774, and 24HMK254.
The raw materials used to manufacture these sterile surgical patties and strips contained higher-than-expected levels of endotoxin, which resulted in out-of-specification endotoxin in the finished goods.
The affected kits were distributed to healthcare facilities in the United States and Canada. Healthcare providers who have received these products should discontinue use and contact Medline Industries for instructions regarding return or replacement of affected items. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 318
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: DYNJ21927R
- 10195327104733(each)
- 40195327104734(case)
- UDI-DI: DYNJ910120A
- 10195327689872 (each)
- 40195327689873 (case)
- Lot Numbers: 24HMK254
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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