FDA Medical devices recall ·
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK… recall
- Recall number
- Z-1370-2025
- Date
- (initiated February 13, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,118 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Why was it recalled?
Potential breach in pouch packaging which could lead to loss of sterility.
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
Item No. CDS985210G, CDS985210G, CDS985210G, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ87398, DYNJ87398, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908744C, DYNJ908744C, DYNJ908744C, DYNJ910326B; UDI (case): 40195327553310, 40195327516193, 40198459034405, 40195327636297, 40195327636280, 40198459075002; UDI (each): 10195327553319, 10195327516192, 10198459034404, 10195327636296, 10195327636289, 10198459075001; Lot No. (Shelf Life) 24LBK011(04/30/2026), 24JBR548(02/28/2026), 24IBN166(02/28/2026), 24KMF425(06/30/2026), 24JMI243(06/30/2026), 24IMI316(05/31/2026), 24HMH127(04/30/2026), 24JBW476(02/28/2026), 24HBK163(02/28/2026), 24KBA490(02/28/2026), 24JBM980(02/28/2026), 24JBB973(02/28/2026), 24IBQ750(03/31/2026), 24JBM981(02/28/2026), 24JBH713(02/28/2026), 24HBJ792(02/28/2026), 24KBQ357(12/31/2025).
Distribution
US Nationwide distribution.
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-1370-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.