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

27226–27250 of 27722

SevereFDA (Devices)·Z-0014-2013·2012-10-17
Baxter Recalls Clearlink Buretrol Solution Sets Due to Valve Malfunction
Baxter Healthcare is recalling Clearlink Buretrol Solution Sets because the ball-valve feature may fail, allowing air to enter the tubing.
Product
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0018-2013·2012-10-17
Accutron Recalls Ultra PC Cabinet Mount Packages Due to Flowmeter Defect
Accutron is recalling 220 Ultra PC Cabinet Mount Packages because the flowmeter may function incorrectly when nitrous gas flows without oxygen.
Product
Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0051-2013·2012-10-17
Terumo Sarns Centrifugal System Control Module Recalled for Power Loss
Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.
Product
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0013-2013·2012-10-17
Baxter Buretrol Solution Set Recalled Due to Ball-Valve Malfunction
Baxter Healthcare is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing.
Product
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0027-2013·2012-10-17
OrthoHelix 3.8mm Cannulated Hex Drivers Recalled for Tip Breakage
Orthohelix Surgical Designs Inc is recalling 120 non-sterile 3.8mm cannulated hex drivers because the tips break while driving screws into patients.
Product
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0015-2013·2012-10-17
Baxter Recalls Clearlink System Buretrol Solution Sets Due to Valve Malfunction
Baxter Healthcare is recalling 488,504 units of Clearlink System Buretrol Solution Sets because the ball-valve feature may allow air to enter the tubing.
Product
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0053-2013·2012-10-17
Terumo Sarns Centrifugal System Control Module Recalled for Power Loss
Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.
Product
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0017-2013·2012-10-17
Accutron Recalls Flowmeter Assemblies for Incorrect Nitrous Gas Function
Accutron is recalling specific Flowmeter assemblies used in analgesia gas machines because they function incorrectly when nitrous gas flows without oxygen.
Product
Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0049-2013·2012-10-17
Terumo Sarns Centrifugal System Battery Backup Recall for Malfunctions
Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.
Product
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
43 states
SevereFDA (Devices)·Z-0012-2013·2012-10-17
Baxter Buretrol Solution Set Recalled for Potential Air Inflow
Baxter is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing at the completion of a dose.
Product
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0028-2013·2012-10-17
Remington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns
Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.
Product
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0026-2013·2012-10-17
OrthoHelix 3.2mm Cannulated Hex Driver Recall Due to Tip Breakage
Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.
Product
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0050-2013·2012-10-17
Terumo Sarns Centrifugal System Battery Backup Recall
Terumo CVS is recalling 289 Sarns Centrifugal System battery backups due to reported malfunctions that could cause unexpected loss of arterial flow.
Product
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
43 states
SevereFDA (Devices)·Z-0020-2013·2012-10-17
Accutron Newport Portable Analgesia Gas Machine Recalled for Flowmeter Defect
Accutron is recalling 220 Newport Portable Analgesia Gas Machines because the flowmeter functions incorrectly when nitrous gas flows without oxygen.
Product
Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0054-2013·2012-10-17
Kardium Recalls TORQ Sternal Closure Devices Due to Metal Part Risk
Kardium is recalling 480 units of the TORQ Sternal Closure Device because a metal part may dislodge during use.
Product
TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2013·2012-10-17
3M Recalls Steri-Vac Gas Sterilizers Due to Electrical Grounding Defect
3M is recalling Steri-Vac 5XL and 8XL gas sterilizers because the electrical grounding mechanism did not meet safety standards.
Product
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0023-2013·2012-10-17
BioMérieux PREVI Isola System Recall for False Negative Results
BioMérieux is recalling PREVI Isola Systems because they may fail to dispense specimens, leading to false negative microbiological test results.
Product
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0032-2013·2012-10-17
Winco Recalls Caremor Cliner Patient Recliners Due to Frame Defect
Winco Mfg. is recalling Caremor Cliner patient recliners because a back frame may not snap properly onto the chair frame.
Product
Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0046-2013·2012-10-17
Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results
Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.
Product
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2013·2012-10-17
Advanced Neuromodulation Systems Recalls Eon Mini Implantable Pulse Generators
Advanced Neuromodulation Systems is recalling 56 Eon Mini Implantable Pulse Generators manufactured in April 2012 due to a potential internal battery contact issue that could cause painful stimulation surges.
Product
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0038-2013·2012-10-17
Medtronic Premier Anterior Cervical Plate Screw Block Recall
Medtronic is recalling 247 units of the Premier Anterior Cervical Plate System Screw Block because gauge lines may be misaligned, potentially causing screws to be measured as 1 mm shorter than their actual length.
Product
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0021-2013·2012-10-17
Beckman Coulter Recalls UniCel DxH 800 Hematology Analyzers
Beckman Coulter is recalling UniCel DxH 800 hematology analyzers because drain ports may plug, causing biohazard exposure or incorrect test results.
Product
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0047-2013·2012-10-17
Beckman Coulter Recalls Access Folate Calibrators Due to Falsely Elevated Results
Beckman Coulter is recalling Access Folate Calibrators because they may produce falsely elevated results that could mask a folate deficiency.
Product
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0037-2013·2012-10-17
Medtronic Atlantis Anterior Cervical Plate Screw Module Recall
Medtronic is recalling Atlantis Anterior Cervical Plate System screw modules because gauge lines may be misplaced, leading to inaccurate screw length measurements.
Product
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0031-2013·2012-10-17
Winco Recalls Caremor Cliner Patient Recliner Chairs Due to Frame Defect
Winco Mfg. is recalling Caremor Cliner recliner chairs because a back frame failed to snap properly onto the chair frame.
Product
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding…
Category
Medical Device
Distribution
6 states

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27226–27250 of 27722