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 deaths or serious injuries are reported, 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

8801–8825 of 27441

HighFDA (Devices)·Z-0770-2023·2023-01-04
Dual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance
Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.
Product
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Tra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0772-2023·2023-01-04
Pilling Wecksorb Cylindrical Sponges recalled due to compromised sterility
TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.
Product
Pilling Wecksorb Cylindrical Sponges
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0769-2023·2023-01-04
Orthopedic Compression Screws Distributed Without FDA Pre-Market Clearance
Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.
Product
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0771-2023·2023-01-04
Remington Medical Automatic Cutting Needle Stylet Longer Than Specified
Remington Medical is recalling 290 Automatic Cutting Needles with lot number 2224920 because the stylet is longer than specified on the label. Affected units were distributed in NC, WV, CA, PA, AL, and TX.
Product
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0744-2023·2022-12-28
HeartWare Model 1102 Driveline Cover May Harden, Delaying Critical Connector Access
HeartWare Model 1102 cardiac assist devices are being recalled because the driveline cover may harden over time, preventing timely access to the critical driveline connector during urgent clinical situations.
Product
HeartWare Model 1102
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-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-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-0758-2023·2022-12-28
Vivid i N ultrasound device batteries may fail, smoke, or catch fire
GE Medical Systems recalls Vivid i N ultrasound machines worldwide because unreplaced batteries may fail, emit smoke, or catch fire. Users should replace batteries every 2 years per the service manual.
Product
Vivid i 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; Musculo-skeletal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0739-2023·2022-12-28
Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Test Results
Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.
Product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0732-2023·2022-12-28
GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Elevations
GE B125M patient monitors may display inaccurate CO2 measurements at high elevations when using mmHg or kPa units. Measurement accuracy can be affected in locations significantly above sea level.
Product
B125M Patient Monitor, REF 6160000-004-XXXXXX
Category
Medical Device
Distribution
0 states
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-0724-2023·2022-12-28
DeVilbiss 525 Oxygen Concentrator Recalled Due to Excessive Heat
DeVilbiss is recalling the 525 oxygen concentrator because the device can become excessively hot, with external parts potentially exceeding 105.8 degrees Fahrenheit. The firm has updated the user manual to include additional safety warnings.
Product
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
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-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-0727-2023·2022-12-28
Corin BIOLOX DELTA ceramic hip replacement heads mislabeled with incorrect sizes
Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. states.
Product
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
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; Musculo-skelet
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-0457-2023·2022-12-28
SurfaceSoap UV Disinfecting Wand Recalled for Excessive Ultraviolet Radiation
PhoneSoap has recalled its SurfaceSoap UV Disinfecting Wand due to excessive ultraviolet-C radiation emission. Approximately 6,700 units distributed nationwide may pose a radiation hazard to users.
Product
The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Category
Medical Device
Distribution
Distributed nationwide
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
HighFDA (Devices)·Z-0735-2023·2022-12-28
Natus Cranial Access Kit Recalled Due to Defective Sterile Surgical Drapes
Natus Medical is recalling 249 Cranial Access Kits distributed nationwide. The sterile surgical drape liners are difficult to remove without damage, potentially rendering the kits unusable for neurosurgical procedures.
Product
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various
Category
Medical Device
Distribution
Distributed nationwide
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-0743-2023·2022-12-28
HeartWare Model 1101 Implant: Hardened Driveline Cover May Delay Connector Access
The driveline cover on some HeartWare Model 1101 implanted pumps may harden over time, making it difficult to access the driveline connector. This could delay urgent maintenance, potentially causing patient harm.
Product
HeartWare Model 1101
Category
Medical Device
Distribution
0 states
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; Musculo-skeletal
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

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8801–8825 of 27441