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

10926–10950 of 39932

ModerateFDA (Devices)·Z-0767-2023·2023-01-04
Acutrak Bone Screws and Fusion Devices Recalled for Lack of FDA Pre-Market Clearance
Acumed LLC is recalling Acutrak bone screws and fusion devices distributed without FDA pre-market clearance. Patients should contact their healthcare provider for guidance.
Product
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0760-2023·2022-12-28
Revaclear 400 Dialyzers Recalled for Potential Internal Blood Leaks
Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.
Product
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0755-2023·2022-12-28
GE Vivid S6 N Ultrasound Battery Fire Risk Recall
GE Vivid S6 N ultrasound systems may experience battery failure, smoke, or fire if batteries are not replaced every 2 years as recommended. Clinicians should replace batteries per manufacturer Service Manual instructions.
Product
Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0742-2023·2022-12-28
HeartWare Model 1100 driveline cover hardening may delay urgent access
HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.
Product
HeartWare Model 1100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0738-2023·2022-12-28
Spinal implant insert may fail to disengage from vertebral body device
NuVasive's X-CORE 2 spinal implants may not disengage properly from the vertebral replacement device, potentially requiring revision surgery. About 2,031 devices worldwide are affected.
Product
X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0750-2023·2022-12-28
HeartWare HVAD Pump Kit driveline cover hardening affects connector access
Driveline cover hardening in HeartWare HVAD Pump Kits may prevent access to critical connectors, potentially delaying emergency repairs. Affected patients should contact their Medtronic field representative for assessment.
Product
HeartWare HVAD Pump Kit, REF MCS1705PU
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0746-2023·2022-12-28
HeartWare HVAD Pump Kit Driveline Cover Hardening Issue
HeartWare HVAD Pump Kit driveline covers may harden over time, making it difficult or impossible to access the driveline connector for urgent servicing. Delayed access could result in patient harm from prolonged pump stoppage.
Product
HeartWare HVAD Pump Kit, REF 1104
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0751-2023·2022-12-28
FDA Class II recall: Medical Action cardiac catheter introduction kit
Medical Action Industries' Port a Cath Kit (cardiac catheter introduction kit) has been subject to an FDA Class II recall affecting 198 cases distributed in Virginia. The specific reason for recall was not provided by the FDA.
Product
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0745-2023·2022-12-28
HeartWare HVAD Pump Kit driveline cover may harden, impeding urgent access
The driveline cover on HeartWare HVAD Pump Kits may harden over time, preventing access to the driveline to controller connector. This could delay urgent intervention for critical device issues.
Product
HeartWare HVAD Pump Kit, REF 1103
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0763-2023·2022-12-28
Revaclear 400 Dialyzers Recalled for Polyurethane Displacement Risk
Baxter Healthcare is recalling Revaclear 400 dialyzers due to reports of polyurethane displacement, which could result in blood leaks during dialysis treatment. The recall affects over 6 million units distributed worldwide.
Product
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0726-2023·2022-12-28
Corin BIOLOX DELTA Ceramic Hip Implant Heads Recalled for Incorrect Size Labeling
Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads nationwide due to size labeling errors. The 36XL size is labeled as 32XL and vice versa, which could result in implantation of an incorrectly sized component.
Product
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2023·2022-12-28
GE Centricity Universal Viewer 6.0 Medical Imaging Software May Hide Studies
GE Medical Systems' Centricity Universal Viewer 6.0 image display software may hide medical studies from users after IAS tool installation, requiring GE assistance to access hidden images and causing delays in reading diagnostic studies.
Product
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0757-2023·2022-12-28
GE Vivid q Ultrasound Systems: Battery Fire Risk Recall
GE is recalling Vivid q ultrasound systems because batteries not replaced every 2 years as recommended may fail and emit smoke or catch fire.
Product
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2023·2022-12-28
Lamaze Chill Teether Recalled for Potential Microbial Growth in Fluid
Lamaze Chill Teether teething rings are being recalled due to potential microbial growth in the internal fluid. This poses an infection risk, particularly for children with weakened immune systems.
Product
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0765-2023·2022-12-28
Medical Action Industries Littauer Scissors Recalled for Debris Contamination
Medical Action Industries is recalling Littauer surgical scissors because the sterile instruments may contain debris that could compromise their safety during clinical use.
Product
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0723-2023·2022-12-28
ConvaTec AQUACEL Foam Ag Adhesive wound dressing recalled for visual contamination
ConvaTec is voluntarily recalling AQUACEL Foam Ag Adhesive wound dressings due to visual contamination (brown spots) found on several dressings. Approximately 5,300 units distributed nationwide are affected.
Product
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0734-2023·2022-12-28
Fresenius 2008T Hemodialysis Machines Recalled for False USB Device Alarm
Fresenius Medical Care is recalling 2008T and 2008T Bluestar Hemodialysis Machines with CDX due to a software and hardware sensitivity to electromagnetic interference that triggers false alarms.
Product
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0759-2023·2022-12-28
Ultrasound System Batteries May Fail, Emit Smoke, or Catch Fire
GE Medical Systems is recalling Vivid q N ultrasound systems due to potential battery failures that could emit smoke or catch fire if batteries are not replaced per the 2-year service manual recommendation.
Product
Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0756-2023·2022-12-28
GE Vivid i Ultrasound Systems Battery Failure Recall
GE Medical Systems is recalling Vivid i ultrasound systems because batteries not replaced every two years may fail, emit smoke, or catch fire. About 7,931 units were distributed worldwide.
Product
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0749-2023·2022-12-28
HeartWare HVAD ventricular assist pump driveline cover hardening recall
HeartWare HVAD ventricular assist pump kits may develop hardened driveline covers that impair access to critical connectors. If urgent servicing is needed, delayed access could result in patient harm from prolonged pump stoppage.
Product
HeartWare HVAD Pump Kit, REF 1205
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0764-2023·2022-12-28
Baxter Revaclear 400 Dialyzers Recalled for Polyurethane Displacement
Baxter Healthcare is recalling Revaclear 400 dialyzers because polyurethane displacement may cause blood leaks during dialysis treatment. Approximately 1.14 million units are affected worldwide.
Product
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0761-2023·2022-12-28
Revaclear 400 Dialyzer recall due to potential internal blood leaks
Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.
Product
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2023·2022-12-28
VADER Pedicle System Torque Wrench Recalled for Out-of-Specification Calibration
Icotec Ag is recalling six VADER Pedicle System Torque Wrench devices due to a calibration error where the torque limiting function was found to be out of specification, delivering 4 Nm instead of the specified 12 Nm.
Product
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0748-2023·2022-12-28
HeartWare HVAD Pump Kit driveline cover hardening may impair urgent access
HeartWare HVAD Pump Kit driveline covers may harden over time, making them difficult to remove for urgent servicing. In an emergency scenario requiring driveline access, delays could harm patients.
Product
HeartWare HVAD Pump Kit, REF 1104JP
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0721-2023·2022-12-28
Medical Imaging Software Update May Hide Patient Studies
After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.
Product
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Category
Medical Device
Distribution
Distributed nationwide

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10926–10950 of 39932