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

10201–10225 of 13731

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-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-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
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 45.0mm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0768-2023·2023-01-04
Acumed Acutrak 2 Bone Screws Recalled for Distribution Without FDA Clearance
Acumed is recalling Acutrak 2 bone screw products distributed without FDA pre-market clearance. Healthcare providers should contact Acumed or the FDA for guidance regarding use and management of these devices.
Product
Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw
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-0730-2023·2022-12-28
GE B125P Patient Monitor CO2 Display May Show Inaccurate Readings at High Altitudes
GE is recalling B125P patient monitors because CO2 measurements may be inaccurate when used at non-sea-level altitudes in mmHg or kPa mode.
Product
B125P Patient Monitor (with E-module slot option), REF 6160000-002
Category
Medical Device
Distribution
0 states
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-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 Cepha
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-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
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-0747-2023·2022-12-28
HeartWare HVAD Pump Kit driveline cover hardening may prevent repairs
A hardened driveline cover on the HeartWare HVAD Pump Kit may prevent or delay access to the driveline to controller connector. If urgent servicing is needed, the delay could result in patient harm from pump malfunction.
Product
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0753-2023·2022-12-28
GE Vivid S6 Ultrasound Systems Recalled for Battery Fire Risk
GE Vivid S6 ultrasound systems are recalled for a potential battery hazard. If not replaced at the recommended 2-year interval, batteries may fail, emit smoke, or catch fire.
Product
Vivid S6 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 Superf
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0762-2023·2022-12-28
Baxter Revaclear 300 Dialyzers Recalled for Polyurethane Displacement
Baxter is recalling approximately 14 million units of Revaclear 300 dialyzers worldwide due to polyurethane displacement that could cause blood leaks. No injuries have been reported.
Product
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
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-0754-2023·2022-12-28
Vivid S5 N Ultrasound Systems Recalled for Potential Battery Fire Hazard
GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.
Product
Vivid S5 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-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-0731-2023·2022-12-28
GE B105M Patient Monitor displays inaccurate CO2 readings at altitude
GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.
Product
B105M Patient Monitor, REF 6160000-003
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-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-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

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10201–10225 of 13731