FDA Medical devices recall ·
See DocMan recall
- Recall number
- Z-0782-2025
- 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
- 48655 units
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
See DocMan
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 CDS981185B, UDI/DI 10884389647141 (EA) 40884389647142 (CS), Lot Numbers: 19CDB151, 19DDD096, 19FDA612, 19IDA540, 19LDB150, 20BDA647, 20DDB481, 20IDA733, 20LDA459; 2) REF CDS983087G, UDI/DI 10193489237351 (EA) 40193489237352 (CS), Lot Numbers: 21LBS976; 3) REF CDS983302G, UDI/DI 10888277753181 (EA) 40888277753182 (CS), Lot Numbers: 19JDB741; 4) REF CDS983302I, UDI/DI 10193489425659 (EA) 40193489425650 (CS), Lot Numbers: 23FDA273, 23IDA781; 5) REF CDS983483G, UDI/DI 10889942946068 (EA) 40889942946069 (CS), Lot Numbers: 19CDB914, 19DDB938, 19GDB412, 19GDC427, 19JDA647, 19KDB084, 19LDC222, 20BDC250, 20EDB879, 20GDC001, 20JDA007, 20JDB542, 20LDB199; 6) REF CDS983483I, UDI/DI 10193489919585 (EA) 40193489919586 (CS), Lot Numbers: 21FDB817, 21HDA571, 21KDB608, 22BDA109; 7) REF CDS984313G, UDI/DI 10193489540437 (EA) 40193489540438 (CS), Lot Numbers: 19GBL203, 20EBC321, 20KBB606; 8) REF DYNJ0101278F, UDI/DI 10193489352351 (EA) 40193489352352 (CS), Lot Numbers: 20FDA999, 20HDA734, 20KDB838, 21ADC024, 21CDA355, 21EDA527, 21GDC529, 21IDA040, 21IDA786, 21JDB214, 21KDC443, 22ADC117, 22CDB133; 9) REF DYNJ0826316K, UDI/DI 10889942092642 (EA) 40889942092643 (CS), Lot Numbers: 19FKB533, 19EKD537; 10) REF DYNJ0826316L, UDI/DI 10193489413496 (EA) 40193489413497 (CS), Lot Numbers: 21IME029, 21IMC729, 20IKB206; 11) REF DYNJ0867411F, UDI/DI 10889942620579 (EA) 40889942620570 (CS), Lot Numbers: 19EDA018; 12) REF DYNJ10130D, UDI/DI 10193489432176 (EA) 40193489432177 (CS), Lot Numbers: 21BBC490,
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-0782-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.