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

39701–39725 of 40480

HighFDA (Devices)·Z-0089-2013·2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0086-2013·2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0077-2013·2012-10-24
Trumpf Medical Systems Recalls Helion and Xenion Surgical Lights
Trumpf Medical Systems is recalling 275 Helion and Xenion surgical lights due to reported fractures of the front joint of the spring arm.
Product
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0081-2013·2012-10-24
Boston Scientific Recalls Leveen Coaccess Introducer Sets for Incorrect Portuguese Instructions
Boston Scientific is recalling 19,716 Leveen Coaccess Introducer Sets because the Portuguese instructions for use contain errors. The devices were distributed in Brazil, Portugal, and Hong Kong.
Product
Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0060-2013·2012-10-24
Zimmer Recalls CPT Modular Hip Stems Due to Packaging Errors
Zimmer Inc. is removing CPT Modular Hip Stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.
Product
CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0062-2013·2012-10-24
Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging Cartons
Zimmer Inc. is removing CPT hip stems from the market because they were packaged in incorrect cartons and distributed domestically and internationally.
Product
CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0080-2013·2012-10-24
Boston Scientific Recalls Leveen Needle Electrodes Due to Incorrect Portuguese Instructions
Boston Scientific is recalling Leveen Coaccess Needle Electrodes because the Portuguese instructions for use contain errors. The recall affects units distributed in Brazil, Portugal, and Hong Kong.
Product
Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0059-2013·2012-10-24
Beckman Coulter Recalls Unicel Closed Tube Aliquotter Units Due to Hardware Error
Beckman Coulter is recalling 18 Unicel Closed Tube Aliquotter units because a hardware motion error may occur. The recall covers units distributed in the US and several international locations.
Product
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0071-2013·2012-10-24
Terumo Backplate Replacement CXFVR 1500 Holder Recalled for Incorrect Configuration
Terumo is recalling 33 Backplate Replacement CXFVR 1500 Holders because they were manufactured with an incorrect configuration of connector supports.
Product
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0061-2013·2012-10-24
Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging
Zimmer, Inc. is removing CPT Hip System femoral stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.
Product
CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0076-2013·2012-10-24
Anspach Effort Recalls Electric Foot Controls Due to Cable Shield Defect
The Anspach Effort, Inc. is recalling 10 electric foot controls used for bone cutting because the cable lacks a shield connection.
Product
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0082-2013·2012-10-24
Aesculap Recalls Two Columbus Femoral Cutting Guides Due to Marking Error
Aesculap, Inc. is recalling two Columbus 4-IN-1 Femoral Cutting Guide Instruments because the laser markings for size identification are incorrect, although the instruments are correctly dimensioned.
Product
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0075-2013·2012-10-24
Anspach Effort Recalls Electric Systems Foot Control Due to Cable Defect
The Anspach Effort, Inc. is recalling 41 Electric Systems Foot Controls because the foot control cable lacks a shield connection.
Product
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0079-2013·2012-10-24
Boston Scientific Recalls LeVeen Needle Electrode Systems for Incorrect Portuguese Instructions
Boston Scientific is recalling LeVeen Standard Needle Electrode Systems because the Portuguese instructions for use are incorrect. The recall affects units distributed in Brazil, Portugal, and Hong Kong.
Product
LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0073-2013·2012-10-24
Sunquest Laboratory Software Recall for Calculation Errors in Online Entry
Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4.0 and later due to potential calculation errors in the Online Entry application.
Product
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0019-2013·2012-10-17
Accutron Recalls Flowmeter Packages for Incorrect Gas Function
Accutron is recalling 220 Flowmeter packages used in analgesia gas machines because they may function incorrectly when nitrous gas flows without oxygen.
Product
CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Category
Medical Device
Distribution
Distributed nationwide
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

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39701–39725 of 40480