FDA Medical devices recall ·
See DocMan recall
- Recall number
- Z-0790-2025
- 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
- 205360 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 CDS780162AA, UDI/DI 10193489262049 (EA) 40193489262040 (CS), Lot Numbers: 20BBO888, 20BBQ352, 20FBR735; 2) REF CDS780162AB, UDI/DI 10193489338447 (EA) 40193489338448 (CS), Lot Numbers: 20GBF853; 3) REF CDS780162AC, UDI/DI 10193489383911 (EA) 40193489383912 (CS), Lot Numbers: 20HBE537, 20IBB263, 20JBB811, 20KBA268, 20LBM232, 21ABA833; 4) REF CDS780162AD, UDI/DI 10193489498950 (EA) 40193489498951 (CS), Lot Numbers: 21ABU170, 21BBQ045, 21DBD059, 21DBS617, 21GBS609, 21HBB525; 5) REF CDS780162X, UDI/DI 10889942840281 (EA) 40889942840282 (CS), Lot Numbers: 19ABX591, 19BBM085, 19CBM932, 19EBF768, 19EBU016, 19EBY613, 19FBI652, 19GBV765; 6) REF CDS780162Y, UDI/DI 10193489694079 (EA) 40193489694070 (CS), Lot Numbers: 19HBC545, 19HBD425, 19JBG849, 19LBO181, 19RBB546, 19VBH579; 7) REF CDS780208F, UDI/DI 10193489494211 (EA) 40193489494212 (CS), Lot Numbers: 21FBD429, 22ABH903, 22BBQ627, 22DBL468, 22EBM543, 22HBH464, 22IBN540, 22KBM775, 23ABM574, 23ABU440; 8) REF CDS981327N, UDI/DI 10889942959273 (EA) 40889942959274 (CS), Lot Numbers: 19ABN030, 19DBH383, 19EBJ379, 19GBI961, 19HBU954, 19JBK986, 19LBW564, 20CBH905, 20EBS213, 20GBU395; 9) REF CDS981327O, UDI/DI 10193489396782 (EA) 40193489396783 (CS), Lot Numbers: 20JBO709, 20LBM343, 20LBM792, 21CBE183, 21DBJ732; 10) REF CDS981327P, UDI/DI 10193489930825 (EA) 40193489930826 (CS), Lot Numbers: 21KBO532, 22ABE609; 11) REF CDS981327Q, UDI/DI 10195327080365 (EA) 40195327080366 (CS), Lot Numbers: 22BMC351, 22BMG728, 22FMF883, 22FMH830, 22GM
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-0790-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.