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 deaths or serious injuries are reported, 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

4976–5000 of 5115

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, w
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-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
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 (Drugs)·D-040-2013·2012-11-14
Merit Medical Systems Recalls Cytosol Ophthalmics Balanced Salt Solution Kits
Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.
Product
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Category
Medical Device
Distribution
4 states
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-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-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 f
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 sign
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, annotate,
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 i
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 ass
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 re
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 apn
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0149-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers all lot codes distributed worldwide.
Product
SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0153-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 39,362 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
Product
SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0152-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 25,393 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision.
Product
SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0144-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk
DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.
Product
SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0145-2013·2012-10-31
SpiraLok 5.0mm Anchors Recalled for Post-Operative Fracture Risk
DePuy Mitek is recalling 232 units of SpiraLok 5.0mm anchors due to post-operative fractures requiring patient revision surgery.
Product
SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0111-2013·2012-10-31
Ethicon Recalls EVICEL Fibrin Sealant Pressure Regulators Due to Embolism Reports
Ethicon is recalling EVICEL Fibrin Sealant pressure regulators after reports of air or gas embolism associated with the use of spray devices.
Product
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0143-2013·2012-10-31
SpiraLok 6.5mm Anchors Recalled Due to Post-Operative Fracture
DePuy Mitek is recalling 372 units of SpiraLok 6.5mm anchors because they fractured after surgery, requiring patient revision.
Product
SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0148-2013·2012-10-31
DePuy Mitek Recalls Seven SpiraLok 5.0 Anchors Due to Fracture
DePuy Mitek is recalling seven SpiraLok 5.0 anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0141-2013·2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 2,560 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.
Product
SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0147-2013·2012-10-31
DePuy Mitek Recalls SPIRALOK Bone Fixation Anchors Due to Fracture
DePuy Mitek is recalling 66 SPIRALOK bone fixation anchors because they can fracture after surgery, requiring patients to undergo revision surgery.
Product
Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide

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4976–5000 of 5115