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

21076–21100 of 40248

ModerateFDA (Devices)·Z-1124-2019·2019-04-17
Roche COBAS INTEGRA 400 plus Recall for Carry-over Issues
Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Product
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1131-2019·2019-04-17
ACUVUE OASYS for Astigmatism Contact Lenses Recalled for Packaging Seal Defects
Johnson & Johnson Vision Care is recalling one lot of ACUVUE OASYS for Astigmatism contact lenses due to potential incomplete packaging seals.
Product
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1125-2019·2019-04-17
Roche cobas c 111 and COBAS INTEGRA 400 plus analyzers recalled for carry-over
Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Product
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1111-2019·2019-04-17
Beaver Xstar Slit Knife Recalled for Size Mismatch Labeling
Beaver Visitec is recalling 196 boxes of Xstar Slit Knives because the package label indicates a 2.4 mm size, while the device marking shows 2.75 mm.
Product
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1108-2019·2019-04-17
Conformis Recalls Two iTotal CR Total Knee Replacement Systems
Conformis, Inc. is recalling two iTotal CR Total Knee Replacement Systems prepared with incorrect patient ID labels and potentially incorrect components.
Product
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1130-2019·2019-04-17
Philips Recalls Two Azurion FlexArm Units Due to Cable Damage
Philips is recalling two Azurion FlexArm units because a manufacturing error caused damage to the 24V power cable of the detector.
Product
Azurion FlexArm, 722079
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1118-2019·2019-04-17
Arrow Two-Lumen Central Venous Catheterization Kit Recalled for Labeling Error
Arrow International Inc is recalling specific lots of Two-Lumen Central Venous Catheterization Kits because the lidstock displays an incorrect priming volume.
Product
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1091-2019·2019-04-17
Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.
Product
Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1126-2019·2019-04-17
Ulrich Torque Limiting Handles Recalled for Exceeding Calibration Life
Ulrich Medical USA Inc. is recalling 25 Torque Limiting Handles because they are beyond their 3-year calibration life.
Product
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-1089-2019·2019-04-17
Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 110°F.
Product
Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1105-2019·2019-04-17
Randox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values
Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.
Product
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1107-2019·2019-04-17
Randox Liquid Immunoassay Premium Controls Recalled for Incorrect Target Value
Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.
Product
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1106-2019·2019-04-17
Randox Immunoassay Controls Recalled for Incorrect Analyzer Target Value
Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.
Product
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-0977-2019·2019-04-10
O-Two Medical e600 Ventilator Recalled for Fire Risk
O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
Product
e600 Automatic Transport Ventilator, Model Number 01EVE600
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0978-2019·2019-04-10
O-Two Medical e700 Ventilator Recalled for Fire Risk
O-Two Medical Technologies is recalling 632 e700 Automatic Transport Ventilators because a manufacturing defect could cause the unit to catch fire.
Product
e700 Automatic Transport Ventilator, Model Number 01EVE700
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0976-2019·2019-04-10
O-Two Medical e500 Ventilator Recalled for Fire Hazard
O-Two Medical is recalling 136 e500 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
Product
e500 Automatic Transport Ventilator, Model Number 01EVE500
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1087-2019·2019-04-10
Zimmer Biomet Recalls RingLoc Hip System Self-Tapping Bone Screws
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws due to a potential packaging error where 30mm screws may be labeled as 20mm and vice versa.
Product
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1086-2019·2019-04-10
Zimmer Biomet Recalls RingLoc Hip System Bone Screws Due to Packaging Error
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.
Product
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2019·2019-04-10
Biomet Cement Plug Inserter Recalled for Sterilization Validation Issues
Zimmer Biomet is recalling 89 units of the Small Diameter Cement Plug Inserter due to a lack of adequate sterilization validation.
Product
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1078-2019·2019-04-10
Beckman Coulter Recalls UniCel DxC Clinical Systems Due to Software Error
Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect test results.
Product
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i…
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-1077-2019·2019-04-10
Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error
Beckman Coulter is recalling UniCel DxI 600 and 800 systems due to a software scheduling error that can cause incorrect immunoassay results.
Product
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-1075-2019·2019-04-10
Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues
Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits due to a stability issue that may cause error codes or out-of-range quality control results.
Product
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1084-2019·2019-04-10
Advanced Bionics Recalls Three Naída CI Q70 Sound Processors
Advanced Bionics is recalling three Naída CI Q70 Sound Processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.
Product
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1079-2019·2019-04-10
Conformis Recalls Two iTotal Knee Replacement Systems for Labeling Errors
Conformis, Inc. is recalling two iTotal Posterior Stabilized Knee Replacement Systems because the box and sterile pouch labels did not match the contents.
Product
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1085-2019·2019-04-10
Advanced Bionics Recalls Naída CI Q90 Sound Processor Due to Firmware Error
Advanced Bionics is recalling one Naída CI Q90 Sound Processor because it was loaded with incorrect firmware. The device was distributed in North Carolina and several foreign countries.
Product
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Category
Medical Device
Distribution
1 state

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21076–21100 of 40248