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

39726–39750 of 40480

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
HighFDA (Devices)·Z-0052-2013·2012-10-17
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, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0036-2013·2012-10-17
Medtronic Atlantis Anterior Cervical Plate Screw Module Recalled for Measurement Error
Medtronic is recalling the Atlantis Anterior Cervical Plate System Variable Angle Screw Module because gauge lines may be misaligned, leading to inaccurate screw length measurements.
Product
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, 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
ModerateFDA (Devices)·Z-0016-2013·2012-10-17
Beckman Coulter Recalls Active Renin IRMA Kit Due to Stability Issues
Beckman Coulter is recalling the Active Renin IRMA Kit because decreased stability in coated tubes may cause falsely elevated test results.
Product
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0035-2013·2012-10-17
Beckman Coulter Recalls TetraCXP Software for Labeling Updates
Beckman Coulter is recalling TetraCXP software and CYTO-STAT reagents to update specimen stability claims in the product labeling.
Product
TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0041-2013·2012-10-17
IDS-iSYS Ostase BAP Control Set Recalled for Incorrect Labeling
Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP Control Sets because they are labeled as IVDs but are not registered for that use in the US.
Product
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0039-2013·2012-10-17
IDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling
Immunodiagnostics Systems Ltd is recalling IDS Urine BETA CrossLaps ELISA kits because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.
Product
IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0034-2013·2012-10-17
Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Stability Claims
Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.
Product
CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0048-2013·2012-10-17
Siemens syngo.plaza Radiological Image Processing System Recall
Siemens is recalling 11 syngo.plaza systems due to a software defect where archived studies may be missing from the database.
Product
Siemens syngo.plaza radiological image processing system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0045-2013·2012-10-17
IDS-iSYS Intact PINP Control Set Recalled for Incorrect IVD Labeling
Immunodiagnostics Systems Ltd is recalling 29 units of IDS-iSYS Intact PINP Control Set because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.
Product
IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the…
Category
Medical Device
Distribution
Distributed nationwide

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39726–39750 of 40480