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

26751–26775 of 27681

HighFDA (Devices)·Z-0837-2013·2013-02-27
International Technidyne Recalls Pro Time 3 Cuvettes for Inaccurate PT/INR Results
International Technidyne Corp. is recalling specific lots of Pro Time 3 Cuvettes because they may produce lower than expected Prothrombin Time/INR results.
Product
Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0832-2013·2013-02-27
CareFusion Recalls SmartSite Gravity Blood Sets Due to Connection Separation
CareFusion is recalling 5,050 units of SmartSite Gravity Blood Sets because the drip chamber and tubing may separate, potentially delaying treatment.
Product
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0842-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Packaging Integrity Issues
Codman & Shurtleff is recalling 867 NeuroPath guiding catheters because packaging defects may compromise sterility. The devices were distributed worldwide.
Product
NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0861-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling 141 units of NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0826-2013·2013-02-27
ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Pouch Seals
ConMed is recalling Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.
Product
ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0863-2013·2013-02-27
Codman Neuropath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0858-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0869-2013·2013-02-27
Integra MAYFIELD Composite Base Units Recalled for Potential Breakage
Integra LifeSciences is recalling 96 MAYFIELD Composite Series Base Units because they may break during use, posing a risk to patients during surgical procedures.
Product
MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical…
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0871-2013·2013-02-27
Philips HeartStart XL+ Defibrillators Recalled for Potential Lockout
Philips is recalling 3,785 HeartStart XL+ defibrillators because they may become locked out of clinical use.
Product
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2013·2013-02-27
Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns
Codman & Shurtleff is recalling 1,548 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0866-2013·2013-02-27
Merit Medical Systems Recalls Biliary Locking Drainage Catheters Due to Breakage
Merit Medical Systems is recalling 387 Resolve Biliary Locking Drainage Catheters because a consumer reported the device broke into several pieces during use.
Product
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0749-2013·2013-02-20
GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings
GE Healthcare is recalling 276 Giraffe and Panda Bag and Mask Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.
Product
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Category
Medical Device
Distribution
31 states
SevereFDA (Devices)·Z-0763-2013·2013-02-20
St. Jude Medical Recalls TorqVue FX Delivery Systems Due to Fracture Risk
St. Jude Medical is recalling 635 TorqVue FX Delivery Systems because the core wire could fracture during use.
Product
St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0795-2013·2013-02-20
Lumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections
Lumenis Limited is recalling VersaCut Tissue Morcellator devices to correct labeling following three reported air embolism events caused by incorrect tubing hook-up.
Product
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0748-2013·2013-02-20
GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings
GE Healthcare is recalling 276 Giraffe and Panda T-Piece Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.
Product
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-0806-2013·2013-02-20
Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives
Remel Inc is recalling specific lots of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.
Product
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0824-2013·2013-02-20
Philips SureSigns VS2+ Vital Signs Monitor Recall for Screen Lockup
Philips Healthcare is recalling 3,248 SureSigns VS2+ monitors because the screen may lock up and stop monitoring patients.
Product
Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0818-2013·2013-02-20
Richmar Foam Electrodes Recalled for Terminal Separation Defect
NAImco Inc dba Richmar Inc is recalling foam electrodes where the socket terminal may pull away from the lead wire. The defect poses a risk of electrical shock or injury.
Product
Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2&quot; x 2&quot; Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2&quot; Round Electrode, Foam, AG, All Serial…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0805-2013·2013-02-20
Aesculap Miethke Shunt System Recalled Due to Deflector Movement Issue
Aesculap, Inc. is recalling 11 units of the Miethke Shunt System because the deflector may not move freely on the ventricular catheter.
Product
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0799-2013·2013-02-20
Fresenius Liberty Cycler Set Recalled for Leak and Contamination Risk
Fresenius Medical Care is recalling 5,590 Liberty Cycler Sets due to a small risk of leaks that could contaminate dialysate and cause peritonitis.
Product
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0801-2013·2013-02-20
Remel Lyophilized Growth Supplement Recalled for Microbial Contamination
Remel Inc is recalling 10 units of a lyophilized growth supplement for Legionella testing due to potential low-level microbial contamination.
Product
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0821-2013·2013-02-20
Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings
Viterion TeleHealth Monitors are being recalled because they do not transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.
Product
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0803-2013·2013-02-20
Breg Cold Therapy Units Recalled for Potential Sterility Compromise
Breg Inc is recalling Cold Therapy Combination Units with Sterile Polar Pads because packaging damage may have compromised sterility assurance.
Product
BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0807-2013·2013-02-20
Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives
Remel Inc is recalling 50 units of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.
Product
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0815-2013·2013-02-20
Richmar Cloth Electrodes Recalled for Terminal Separation Defect
NAImco Inc dba Richmar Inc is recalling specific cloth electrodes because the socket terminal may pull away from the lead wire. The defect could cause electrical stimulation issues.
Product
Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2&quot; x 2&quot; Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N…
Category
Medical Device
Distribution
2 states

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26751–26775 of 27681