Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure
Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.
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 critical respiratory support device. Although no illnesses or injuries have been reported, the valve malfunction directly threatens oxygen delivery to mechanically ventilated patients, and the FDA's Class I designation reflects a reasonable probability of serious injury or death.
Plain-English summary
Mallinckrodt Manufacturing LLC is recalling approximately 13,602 One-Way Valves, model 22F x 22M, designed for use with ventilators. The recall involves Part #91346 (individual unit) and Part #50412 (5-pack), identified by specific lot codes and UDI codes.
The One-Way Valve may stick internally and prevent or reduce the flow of ventilated air or oxygen. This malfunction could compromise the delivery of respiratory support to patients requiring mechanical ventilation.
The affected devices have been distributed worldwide. Healthcare facilities and individuals using these valves should immediately verify whether they possess any of the affected lot codes or UDI numbers.
The recalled product
- Product
- Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
- Manufacturer
- Mallinckrodt Manufacturing LLC
- Affected units
- 13,602
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 (7)
- a) UDI/DI 10810055283460
- Lot Codes: 74L2001714
- 74L2001715
- 74L2001716
- 74M2001125
- 74B2100237
- b) UDI/DI 10810055283467
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Mallinckrodt Manufacturing LLC
See all →- ModerateMallinckrodt Recalls ArterX Surgical Sealant Due to Improper Labeling
FDA (Devices) · 2017-07-12
Same hazard · stuck valve
See all →- High
Other medical device recalls
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
Similar recalls
- HighTeleflex Medical One Way Valve Recall for Potential Disconnection
FDA (Devices) · 2018-04-25
- HighWilson Manifolds Recalls Peter Paul Nitrous Solenoid Valves
NHTSA · 2016-06-13
- HighHamilton Medical Recalls MR1 Ventilators Due to Oxygen Tubing Loosening Risk
FDA (Devices) · 2016-12-07
- HighGA Health Recalls ScopeValet Guardian Disposable Endoscope Valves Due to Defect
FDA (Devices) · 2020-12-30
- HighWatts Recalls 4,500 Gas Ball Shut-Off Valves Due to Leak Risk
CPSC · 2005-11-10
- ModerateMallinckrodt Evac Tracheal Tubes Recalled for Unsealed Packaging
FDA (Devices) · 2016-05-18