FDA DevicesClass I
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor...
Published: April 15, 2026Recall ID: Z-1730-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
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.
Affected 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.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98598 |
| Address 1 | 3 Lakes Dr |
| Code info | 1. Medline SKU # DYNJ30880M, UDI/DI each 10198459446207, UDI/DI case 40198459446208, Lot Number: 25LMJ532; 2. Medline SKU # DYNJ64295A, UDI/DI each 10193489353853, UDI/DI case 40193489353854, Lot Number: 24KMI274. |
| Postal code | 60093-2753 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 82 kits |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260407 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide 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).