NAMIC Stopcocks Recalled Due to Potential Sterile Barrier Breach
Medline Industries is recalling NAMIC Stopcocks due to potential sterile barrier breaches from microscopic pinholes in sterile pouches, which could allow non-sterile conditions.
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 is an FDA Class II recall of medical devices used in sterile medical applications. While no illnesses or injuries have been reported, the potential for sterile barrier breach from manufacturing defects in these devices creates a risk of harm in healthcare settings where contamination could lead to serious infections.
Plain-English summary
Medline Industries Inc is recalling NAMIC Stopcocks in multiple models and pressure ratings (200 psi, 400 psi, and 1050 psi). The affected products include three-way stopcocks, four-way stopcocks, and one-way stopcocks with various configurations, all labeled as prescription-only and sterile.
The stopcocks are being recalled because microscopic pinholes in the sterile pouches could potentially compromise the sterile barrier, resulting in non-sterile conditions. These are medical devices used in healthcare settings where sterility is critical to patient safety.
Affected products have been distributed worldwide, including the United States and to Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore, South Africa, South Korea, Thailand, and United Kingdom. The recalled units have expiration dates ranging from December 31, 2023 through July 12, 2024, with specific lot numbers identified by the manufacturer.
Users of affected stopcocks should immediately stop using the recalled products and contact Medline Industries or their healthcare provider for guidance on replacement or return of the affected units.
The recalled product
- Product
- NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, S
- Manufacturer
- Medline Industries Inc
- Affected units
- 816,420
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)
- 0000004540
- 0000004748
- 0000004762
- 0000005986
- 0000006006
- 0000008507
- 0000008561
- 0000010311
- 0000011009
- 0000011021
- 0000012601
- 0000012667
- 0000013628
- 0000013629
- 0000014168
- 0000015265
- 0000015855
- 0000016237
- 0000017369
- (2) REF 70015003 - Lot numbers 0000002035
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medline Industries Inc 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 2 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Vascular CDS Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27