Hazard

Valve Malfunction recalls

34 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 34
Critical: 0
Severe: 0
Most recent: 2025-02-12

Of the 34 valve malfunction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all valve malfunction recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–34 of 34

HighFDA (Devices)·Z-1915-2023·2023-06-21
Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure
Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2023·2023-06-21
Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2457-2021·2021-09-22
BD Syringe Set Needle-Free Connector Valves May Cause Therapy Delay
BD Syringe Set needle-free connector valves may experience difficulty flushing, flow issues, or occlusions that could delay patient therapy. About 16,700 units have been distributed worldwide.
Product
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2026-2021·2021-07-14
Siemens Atellica Analyzer Valves Recalled for Manufacturing Defect Risk
Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.
Product
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2027-2021·2021-07-14
Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect
Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.
Product
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0959-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 31 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2014·2014-07-02
SteriGear Recalls Urinary Drain Bags Due to Valve Malfunction
SteriGear is recalling 110,560 urinary drain bags because the valve can close and create negative pressure, potentially blocking urine flow.
Product
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2014·2013-11-20
DePuy Mitek FMS Outflow Tubing Recalled Due to Valve Malfunction
DePuy Mitek is recalling FMS Outflow Tubing because the pillow valve may not perform as intended, potentially leading to backflow of irrigation fluid and patient cross-contamination.
Product
DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2014·2013-11-20
DePuy Mitek FMS Intermediary Tubing Recalled Due to Valve Malfunction
DePuy Mitek is recalling FMS Intermediary Tubing with One-Way Valve because the pillow valve may not perform as intended, potentially leading to patient cross-contamination.
Product
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing int
Category
Medical Device
Distribution
Distributed nationwide