FDA Medical devices recall ·
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC… recall
- Recall number
- Z-0783-2025
- Date
- (initiated November 21, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 943 units
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; 6) DIEP FLAP, REF DYNJ66867A; 7) KIT FREE FLAP MOSES, REF DYNJ905366A; 8) FREE FLAP, REF DYNJ905634B; 9) ROBOTIC THORACIC, REF DYNJ907817; 10) TRANSPHENOIDAL, REF DYNJ908165; 11) METREX, REF DYNJ910072; 12) DIEP FLAP, REF DYNJ910120A.
Why was it recalled?
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) REF DYNJ0991320J, UDI/DI 10193489686661 (EA) 40193489686662 (CS), Lot Numbers: 19EKB321, 19GKD099, 19JKA065, 19LKB378, 20DKA223, 20EKA239, 20FKB859, 20GKA150, 20HKB438, 21ALA327; 2) REF DYNJ21927R, UDI/DI 10195327104733 (EA) 40195327104734 (CS), Lot Numbers: 23JBK732; 3) REF DYNJ40406A, UDI/DI 10889942215904 (EA) 40889942215905 (CS), Lot Numbers: 23HBD879; 4) REF DYNJ51818F, UDI/DI 10889942741601 (EA) 40889942741602 (CS), Lot Numbers: 19BBA689, 19CBD918; 5) REF DYNJ58648F, UDI/DI 10193489884449 (EA) 40193489884440 (CS), Lot Numbers: 21EMF317; 6) REF DYNJ66867A, UDI/DI 10193489986235 (EA) 40193489986236 (CS), Lot Numbers: 22ABE990, 22FBV019, 22KBK097, 22NBE822, 23DBG870, 23EBR848, 23FBA588, 23HBX771, 23IBW237, 23KBC127, 23KBT141; 7) REF DYNJ905366A, UDI/DI 10193489759372 (EA) 40193489759373 (CS), Lot Numbers: 19LBL885, 20BBJ487, 20CBF683, 20FBC462, 20HBN061, 21CBU514, 21DBO189, 21EBI475, 21EBN240, 21FBT699, 21FBT700, 21FBT702, 21KBN245; 8) REF DYNJ905634B, UDI/DI 10193489633924 (EA) 40193489633925 (CS), Lot Numbers: 19EBD435, 19EBL594, 19FBG295, 19GBR466, 19GBS384, 20FBS328, 21EBM629, 21FBP379, 21FBT340, 22GMH714, 23CMF811, 23DMA128, 23JMD524, 24AMJ344, 24BME042, 24DMB281, 24EMI831, 24FMC477; 9) REF DYNJ907817, UDI/DI 10193489887167 (EA) 40193489887168 (CS), Lot Numbers: 21EBC333; 10) REF DYNJ908165, UDI/DI 10193489992014 (EA) 40193489992015 (CS), Lot Numbers: 22CLA236, 22CLA782, 22FLA058, 22JBI497, 23BBD054, 23BBF440, 23BBG445, 23BBL712, 23FBA102, 23IBO315, 23KBH043, 23KBH
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0783-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.