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

39376–39400 of 40356

SevereFDA (Devices)·Z-0284-2013·2012-11-21
Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling 26 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
Product
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0282-2013·2012-11-21
Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling 466 Sarns Modular Perfusion System 8000 units due to arterial and cardioplegia monitor malfunctions, including power issues and inaccurate pressure alarms.
Product
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2013·2012-11-21
Dako PT Link Waterbath Recalled for Electrical Shock Hazard
Dako North America Inc. is recalling 136 PT Link Waterbath units due to a potential electrical shock hazard if the heater pad becomes wet.
Product
PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0280-2013·2012-11-21
Terumo Recalls Sarns Modular Perfusion System 8000 Due to Monitor Malfunctions
Terumo CVS is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
Product
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0279-2013·2012-11-21
Terumo HX2 Temperature Management System Recalled for Board Defect
Terumo is recalling 15 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.
Product
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0296-2013·2012-11-21
Zimmer Recalls ATS 3000 Tourniquets Due to Counterfeit Chip Failures
Zimmer is voluntarily removing 204 ATS 3000 Automatic Tourniquet Systems worldwide after complaints of failures caused by counterfeit chips.
Product
ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0286-2013·2012-11-21
Stryker Recalls Peri-Acetabular Prosthesis Femoral Extension Components
Stryker Howmedica Osteonics is recalling 301 units of Peri-Acetabular Prosthesis V40 Femoral Extension Components due to insufficient taper torsional strength when used with forged CoCr stems.
Product
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0288-2013·2012-11-21
Trivascular Recalls Fill Polymer Kits Due to Potential Stopcock Leaks
Trivascular is recalling 41 units of Fill Polymer Kits in European distributor inventory due to potential stopcock cracks that may cause leaks.
Product
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0294-2013·2012-11-21
MOOG Recalls EnteraLite Infinity Enteral Feeding Pumps Due to Voltage Defect
MOOG Medical Devices Group is voluntarily recalling specific EnteraLite Infinity enteral feeding pumps because a PCB defect may cause the device to shut down.
Product
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0281-2013·2012-11-21
Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
Product
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0278-2013·2012-11-21
Terumo HX2 Temperature Management System Recalled for Board Defects
Terumo is recalling 19 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.
Product
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0283-2013·2012-11-21
Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling 312 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
Product
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0276-2013·2012-11-21
Progressive Medical Recalls Endoscopic Dissectors with Broken Sterile Seals
Progressive Medical Inc. is recalling 70 boxes of PMI Endoscopic Dissectors because some sterile packages had broken seals, potentially compromising sterility.
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. Exclusively Distributed in the U.S. Market by: Progressive…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0277-2013·2012-11-21
Synthes External Fixation Clamp Recalled for Incorrect MR Safety Labeling
Synthes USA HQ, Inc. is recalling 8 units of External Fixation System Tube to Tube Clamps because the provided insert incorrectly states the product is MR safe, while the device is actually MR Conditional.
Product
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0295-2013·2012-11-21
Gulf South Medical Supply Recalls Vinyl Exam Gloves Shipped Before Customs Clearance
Gulf South Medical Supply is recalling Select Medical Products Vinyl Powder-Free Exam Gloves because they were shipped before U.S. Customs cleared them for sale.
Product
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0289-2013·2012-11-21
Horiba Medical Recalls ABX PENTRA Creatinine 120 CP Reagent
Horiba Medical is recalling ABX PENTRA Creatinine 120 CP reagent because a calibration alarm prevents the assay from being used.
Product
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0273-2013·2012-11-14
Sorin S5 Perfusion System Recalled for Motor Controller Fault
Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.
Product
S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0270-2013·2012-11-14
Primus Medical Recalls Prime Bed TL500 Hospital Beds Due to Frame Collapse Risk
Primus Medical LLC is recalling 342 Prime Bed TL500 hospital beds because retaining washers and clevis pins may fail, causing the bed frame to collapse.
Product
AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0266-2013·2012-11-14
Stryker Recalls Hoffman LRF Telescopic Struts Due to Breakage
Stryker Howmedica Osteonics Corp. is recalling 165 Hoffman LRF Telescopic Struts because three complaints reported the devices breaking during load-bearing use in patients weighing over 250 lbs.
Product
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0272-2013·2012-11-14
Sorin S5 Perfusion System Recalled for Motor Controller Fault
Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.
Product
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0271-2013·2012-11-14
Sorin S5 Perfusion System Recalled for Motor Controller Faults
Sorin Group USA is recalling S5 Perfusion Systems due to motor controller faults that may cause unintended pump stoppage during surgery.
Product
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0274-2013·2012-11-14
Sorin S5 Perfusion System Recalled for Motor Controller Faults
Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that could cause unintended pump stoppage during surgery.
Product
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0275-2013·2012-11-14
Sorin C5 Perfusion System Recalled for Motor Controller Fault
Sorin Group USA recalled two Sorin C5 Perfusion Systems due to a motor controller fault that could cause pump stoppage during surgery.
Product
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2013·2012-11-14
Sendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error
Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.
Product
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0268-2013·2012-11-14
Kerr Recalls AlgiNot Dental Impression Material Due to Curing Defect
Kerr Corporation is recalling AlgiNot dental impression material because it may cure harder than expected, potentially causing tooth fractures in patients with loose teeth.
Product
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a…
Category
Medical Device
Distribution
Distributed nationwide

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39376–39400 of 40356