Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

39576–39600 of 40480

LowFDA (Devices)·Z-0192-2013·2012-11-14
Abbott Recalls Cliniqa Liquid QC Cardiac Marker Control for i-STAT
Abbott Point of Care is recalling specific lots of Cliniqa Liquid QC Cardiac Marker Control for i-STAT because results may be generated below the lower value assignment range.
Product
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0246-2013·2012-11-14
Zimmer NCB-PH Plate Label Correction for Reference and Lot Number Discrepancies
Zimmer, Inc. is correcting patient labels for NCB-PH Plates manufactured before March 2010 due to discrepancies in reference and lot numbers.
Product
NCB¿-PH Plate
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0248-2013·2012-11-14
Zimmer Kopf Adapter S Sterile Recalled for Label Discrepancies
Zimmer Inc. is correcting patient labels for Kopf Adapter S Sterile products manufactured before March 2010 due to reference and lot number discrepancies.
Product
Kopf Adapter S Sterile, Rx
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0243-2013·2012-11-14
Zimmer NCB Cancellous Screw Label Correction Recall
Zimmer Inc. is correcting patient labels for NCB cancellous screws due to discrepancies in reference and lot numbers.
Product
NCB¿ cancellous screw
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0244-2013·2012-11-14
Zimmer NCB Screw Label Correction for Reference and Lot Number Discrepancies
Zimmer Inc. is correcting patient labels for NCB screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
Product
NCB¿ screw ¿ 4.0 self-tapping
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0189-2013·2012-11-14
Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling specific lots of Boule Con-Diff Hematology Control vials due to a received complaint.
Product
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Category
Medical Device
Distribution
31 states
LowFDA (Devices)·Z-0194-2013·2012-11-14
Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials because customers reported inaccurate MCV and RDW% values.
Product
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0174-2013·2012-11-07
Ventlab Infant Resuscitator Recalled for Possible Volume Leakage
Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.
Product
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0172-2013·2012-11-07
Ventlab Stat-Check Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of Stat-Check Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
Product
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0171-2013·2012-11-07
Ventlab Pro-5000 Adult Resuscitator Recalled for Volume Leakage
Ventlab Corporation is recalling 14,602 Pro-5000 Series Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
Product
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0170-2013·2012-11-07
Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during bag compressions.
Product
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0177-2013·2012-11-07
Ventlab Premium Small Child Resuscitator Recalled for Valve Leakage
Ventlab Corporation is recalling 14,602 Premium Small Child Resuscitators due to possible volume leakage through the inlet valve during compressions.
Product
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0169-2013·2012-11-07
Elekta MOSAIQ Medical Record System Recalled for Treatment Data Error
Elekta, Inc. is recalling MOSAIQ electronic medical record systems because a user error led to a patient being seriously mistreated.
Product
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0180-2013·2012-11-07
Ventlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
Ventlab is recalling 14,602 AirFlow Infant Resuscitators because the inlet valve may leak air during compressions, potentially compromising respiratory support.
Product
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0178-2013·2012-11-07
Ventlab Premium Small Adult Resuscitator Recalled for Valve Leakage
Ventlab Corporation is recalling 14,602 Premium Small Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
Product
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0175-2013·2012-11-07
Ventlab AirFlow Resuscitator Recalled for Inlet Valve Leakage
Ventlab Corporation is recalling 14,602 AirFlow Resuscitators due to possible volume leakage through the inlet valve during bag compressions.
Product
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0124-2013·2012-11-07
HeartSine Samaritan 300/300P PAD Devices Recalled for Malfunction
Heartsine is recalling 81,982 Samaritan 300/300P PAD devices because they may turn on or off unexpectedly, potentially preventing therapy delivery during cardiac arrest.
Product
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0176-2013·2012-11-07
Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during use.
Product
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0181-2013·2012-11-07
Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of AirFlow Small Adult Resuscitators due to possible volume leakage through the inlet valve during compressions.
Product
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0179-2013·2012-11-07
Ventlab Infant Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling 14,602 infant resuscitators due to possible volume leakage through the inlet valve during bag compressions.
Product
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0173-2013·2012-11-07
Ventlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage
Ventlab Corporation is recalling V*Care Infant Resuscitators due to a possible volume leakage through the inlet valve during compressions.
Product
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0165-2013·2012-11-07
Oscor Recalls Myocardial Heart Wires Due to Spacing Defect
Oscor, Inc. is recalling specific models of myocardial heart wires because the spacing between the anchoring zig-zag and the electrode is out of specification.
Product
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0160-2013·2012-11-07
Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Connector Detachment Risk
Maquet Cardiovascular is recalling QUADROX oxygenators because the blood outlet connector may detach from the device during use.
Product
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0167-2013·2012-11-07
Sorin SCP Pump Control Panel Recalled for Circuit Board Malfunction
Sorin Group USA is recalling SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.
Product
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0159-2013·2012-11-07
Progressive Medical Recalls Endoscopic Dissector Due to Tip Unraveling Risk
Progressive Medical Inc is recalling 124 boxes of PMI Endoscopic Dissectors because the tip could come loose or unravel during use.
Product
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue…
Category
Medical Device
Distribution
Distributed nationwide

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39576–39600 of 40480