FDA Medical devices recall ·
Medline brand, medical procedure convenience kits… recall
- Recall number
- Z-0724-2025
- Date
- (initiated November 6, 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
- 12,889 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; 6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D; 7) NEURO BUNDLE-LF, SKU DYNJ40095A; 8) NEURO BUNDLE-LF, SKU DYNJ40095B; 9) NEURO BUNDLE-LF, SKU DYNJ40095C; 10) NEURO BUNDLE-LF, SKU DYNJ40095D; 11) NEURO PACK-LF, SKU DYNJ42844D; 12) WMC VP SHUNT PACK-LF, SKU DYNJ50629J; 13) NEURO PACK, SKU DYNJ54255A; 14) NEURO CHRISTUS, SKU DYNJ61190A; 15) NEURO KIT, SKU DYNJ62854B; 16) NEURO KIT, SKU DYNJ62854C; 17) NEURO PACK NTX, SKU DYNJ66213D; 18) NEURO PACK, SKU DYNJ67628C; 19) BASIC NEURO CUSTOM, SKU DYNJ83387; 20) BASIC NEURO CUSTOM, SKU DYNJ83387A; 21) HALY NEURO PACK, SKU DYNJ87308; 22) FHWC NEURO, SKU DYNJ906131B; 23) CRANI, SKU DYNJ907865; 24) KIT NEURO LAFAYETTE, SKU DYNJ908615C; 25) GENERAL NEURO, SKU DYNJ909744
Why was it recalled?
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
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
UDI-DI: CDS780119T, 10888277762688 (each), 40888277762689 (case), Lot Numbers: 20EBU829; UDI-DI: CDS981327Q, 10195327080365 (each), 40195327080366 (case), Lot Numbers: 22FMH830 22FMF883; UDI-DI: DYNJ0311501I, 10889942265886 (each), 40889942265887 (case), Lot Numbers: 22DMF117; UDI-DI: DYNJ37741D, 10195327548940 (each), 40195327548941 (case), Lot Numbers: 24EMD032; UDI-DI: DYNJ39836C, 10193489510324 (each), 40193489510325 (case), Lot Numbers: 20JMB588 20GMD367 20EMB420 20CMC383 20CMA256; UDI-DI: DYNJ39836D, 10193489477177 (each), 40193489477178 (case), Lot Numbers: 22EMA431 22CMC948 22BMD597 22AMG597 21JMF846 21IMA074 21GMF465 21GMC844 21CME103 21CMD623 21BMC249; UDI-DI: DYNJ40095A, 10193489370690 (each), 40193489370691 (case), Lot Numbers: 21KME983 21JMB244 21JMB245 21HMA330 21EME688 21DME512 21CMA323 20LMD710 20HMB030; UDI-DI: DYNJ40095B, 10195327068325 (each), 40195327068326 (case), Lot Numbers: 22GMB406 22EMA845 22CME763; UDI-DI: DYNJ40095C, 10195327211028 (each), 40195327211029 (case), Lot Numbers: 22JMH236; UDI-DI: DYNJ40095D, 10195327281250 (each), 40195327281251 (case), Lot Numbers: 24HMC151 24GMA340 24DMK362 24CMH592 24BMF793 24AMF590 24AMD886 23LMB475 23KMD199 23IMF930 23HMG523 23HMB850 23GMI744 23GMH136 23FMD605 23EMC157 23CME914 23BMC902 22LME175; UDI-DI: DYNJ42844D, 10193489880564 (each), 40193489880565 (case), Lot Numbers: 22HBZ336; UDI-DI: DYNJ50629J, 10195327081324 (each), 40195327081325 (case), Lot Numbers: 22FBF021; UDI-DI: DYNJ54255A, 10889942765256 (each),
Distribution
US Nationwide. 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-0724-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.