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

33726–33750 of 40325

HighFDA (Devices)·Z-0887-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0876-2015·2015-01-07
Bard Caliber Inflation Device Recalled for Pressure Limitations
Perouse Medical is recalling Bard Caliber inflation devices that may fail to reach required pressure, potentially delaying angioplasty procedures.
Product
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0898-2015·2015-01-07
Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure
Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge safety hypodermic needles because the needle is not captured in the safety sheath.
Product
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2015·2015-01-07
Atricure CryoICE Cryogenic Probe Recalled for Potential Sterility Compromise
Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.
Product
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2015·2015-01-07
Smiths Medical Needle Pro Edge Safety Device Recall for Uncaptured Needles
Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge Safety Devices because the needle is not captured in the safety sheath.
Product
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0894-2015·2015-01-07
ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0878-2015·2015-01-07
Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error
Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected units were distributed internationally.
Product
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0900-2015·2015-01-07
Zimmer Recalls Osteobond Bone Cement Due to Adhesive Transfer Defect
Zimmer, Inc. is recalling 40 units of Osteobond Bone Cement because samples failed to meet visual requirements for adhesive transfer between the Tyvek lid and cavity.
Product
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0877-2015·2015-01-07
Perouse Medical Recalls Synthes Inflation System Due to Pressure Limitations
Perouse Medical is recalling 2,184 units of the Synthes Inflation System because the device may fail to raise pressure above 10 atm, potentially delaying procedures.
Product
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0879-2015·2015-01-07
Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error
Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected devices were distributed internationally.
Product
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0868-2015·2014-12-31
Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0585-2015·2014-12-31
Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult Radiotranslucent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
Product
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0867-2015·2014-12-31
Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach during use, potentially compromising airway management.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0587-2015·2014-12-31
Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper device operation.
Product
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0584-2015·2014-12-31
Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult/Child Radiotransparent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
Product
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0865-2015·2014-12-31
Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment Risk
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0872-2015·2014-12-31
Invacare PerfectO2 Oxygen Concentrator Capacitor Recall for Fire Hazard
Invacare is recalling Dianz Capacitors used in PerfectO2 Oxygen Concentrators because they may rupture and cause a fire.
Product
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0869-2015·2014-12-31
Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0866-2015·2014-12-31
Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment
Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach from the tube during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0583-2015·2014-12-31
Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes that fail to connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
Product
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0848-2015·2014-12-31
Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
Ortho-Clinical Diagnostics is recalling specific VITROS TRIG slides due to a potential for biased test results. The recall affects 380 units in the US and 155 units internationally.
Product
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0586-2015·2014-12-31
Heart Sync Multi-function Defibrillation Electrodes Recalled for Incompatibility
Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper use.
Product
ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0802-2015·2014-12-31
GE Healthcare Pediatric Defibrillation Electrodes Recalled for Arcing Risk
Leonhard Lang GmbH is recalling GE Healthcare Pediatric Defibrillation Electrodes because arcing may cause malfunction, delaying or preventing life-saving therapy.
Product
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

33726–33750 of 40325