Medline Medical Convenience Kits with Namic Manifold recalled
Medline Industries is recalling medical convenience kits containing Namic Manifolds due to particulate matter found in the fluid path. The recall affects three kit models distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device used in critical catheterization procedures where particulate contamination in the fluid path poses significant risk of harm to patients, meeting the Severe threshold for Class I medical device recalls.
Plain-English summary
Medline Industries, LP is recalling Medline medical convenience kits containing Namic Manifolds. The recalled kits are labeled as: (1) ANGIOGRAPHY CATH LAB, Kit Number DYNJ23532C; (2) CATH LAB PACK, Kit Number DYNJ65185; and (3) ANGIO KIT, Kit Number VASC1057.
The recall was initiated because particulate matter has been identified within the fluid path of the Manifolds.
The recalled kits were distributed nationwide in the United States and internationally to Australia, Austria, Canada, Japan, Korea, the Netherlands, Singapore, and Slovakia. A total of 508 kits are affected.
Facilities using these kits should review their stock against the lot numbers and UDI codes provided by Medline. Healthcare providers should contact Medline for instructions regarding return or disposal of affected products.
The recalled product
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
- Manufacturer
- Medline Industries, LP
- Affected units
- 508
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Medline Kit Number/SKU DYNJ23532C: UDI/DI each 10193489460872
- UDI/DI case 40193489460873
- Lot Number: 25DMA809
- Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146
- UDI/DI case 40193489253147
- Lot Number: 23GBA252
- Lot Number: 23HBI873
- Lot Number: 23IBR043
- Lot Number: 23KBF277
- Lot Number: 24ABQ959
- Medline Kit Number/SKU VASC1057: UDI/DI each 10889942431922
- UDI/DI case 40889942431923
- Lot Number: 25KMF194.
Distribution
Part of a larger recall action
This product is one of 11 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
Same hazard · particulate contamination
See all →- CriticalCardiovascular Procedure Kits Recalled Due to Particulate in Fluid Path
FDA (Devices) · 2026-08-05
- HighLidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- SevereMedline Medical Convenience Kits with Namic Manifold Fluid Contamination
FDA (Devices) · 2026-05-20
- SevereMedline Cardiac Catheterization Kits Recalled for Particulate Contamination
FDA (Devices) · 2026-05-20
Similar recalls
- SevereHalyard convenience kits containing Medline Namic manifolds recalled due to particulates
FDA (Devices) · 2026-08-12
- CriticalHalyard Convenience Kits Recalled Due to Particulates in Manifolds
FDA (Devices) · 2026-08-12
- CriticalHalyard convenience kits recalled due to potential particulates in manifolds
FDA (Devices) · 2026-08-12
- HighMedline Namic Convenience Kits Pressure Monitoring Lines Recalled for Manufacturing Defect
FDA (Devices) · 2025-04-02
- HighMedline recalls surgical convenience kits due to potential contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 663 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02