FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline shoulder arthroscopy and extremity kits recalled for loose syringe connection risk
OTHERNationwide distribution
Stop using affected Medline medical kits
Medline has recalled certain shoulder arthroscopy and extremity medical convenience kits because the syringe adapter may unwind during use. This could cause the syringe to loosen or disconnect from the manifold, potentially disrupting a medical procedure. No injuries have been reported.
- Check if you have Medline SKU # DYNJ30880M (Lot 25LMJ532) or SKU # DYNJ64295A (Lot 24KMI274)
- Stop using these kits immediately
- Contact Medline or your supplier to return or dispose of the recalled kits
- Report any use of these kits to your healthcare facility or Medline
Hazard
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Sold states
Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).
Affected count
82 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1730-2026More Medline Industries, LP recalls
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline medical procedure kits recalled for pain medication quality issues
- FDA-Device2026-07-29Medline urology robotic procedure packs recalled for defective Bard Silastic Foley Catheters
- FDA-Device2026-07-29Medline medical convenience kits recalled for potential Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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