NAMIC Angiographic Manifolds Recalled for Potential Sterile Barrier Compromise
Medline Industries recalled 816,420 NAMIC Angiographic Manifolds due to potential microscopic pinholes in sterile pouches that could compromise device sterility. No injuries reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a potential sterile barrier compromise (microscopic pinholes in sterile pouches) of medical devices used in invasive vascular procedures. While no illnesses or injuries have been reported, the hazard is theoretical but represents a risk-of-harm product, meeting the High severity criterion.
Plain-English summary
Medline Industries has recalled 816,420 NAMIC Angiographic Manifolds (13 product variants) due to a potential sterile barrier breach. Microscopic pinholes within the sterile pouches could allow non-sterile conditions, compromising device sterility before use. The affected devices include 13 product variants with reference numbers 64038301, 64038303, 70037200, 70037202, 70037301, 70037303, 70038200, 70038202, 70038301, 70038303, 70039202, 70039301, and 70039303, with expiration dates from December 31, 2023 to June 30, 2024.
The recalled manifolds were distributed nationwide in the US and internationally to 15 additional countries including Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore, South Africa, South Korea, Thailand, and the United Kingdom. These are prescription-only, sterile devices used in angiographic procedures by healthcare facilities.
Healthcare providers should immediately discontinue use of affected manifolds and verify lot numbers against the FDA recall notice. Contact Medline Industries for replacement and disposal guidance. No patient injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold,
- Manufacturer
- Medline Industries Inc
- Hazard
- sterile-barrier-breach
- contamination-risk
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 (20)
- 0000008482
- 0000016519
- UPN H965640383011 - Lot number 5642413
- (2) REF 64038303 - Lot numbers 0000010144
- 0000014189
- 0000016524
- UPN H965640383031 - Lot number 5642416
- (3) REF 70037200 - Lot numbers 0000002033
- 0000008570
- 0000016521
- UPN H965700372001 - Lot numbers 5649219
- 5659335
- (4) REF 70037202 - Lot numbers 0000014365
- 0000016522
- UPN H965700372021 - Lot numbers 5642417
- 5642565
- 5642566
- 5642567
- 5642568
- 5643626
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- ModerateMedline Lumbar Puncture Kit recalled for Lidocaine quality issues
FDA (Devices) · 2026-07-08
- ModerateMedela ENFit ExSet Enteral Extension Set Connector Compatibility Issue
FDA (Devices) · 2026-07-08
- ModerateCRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided 15-18mm 240cm Medical Device Sterile Pouch Breach
FDA (Devices) · 2026-07-08