Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

14926–14950 of 53092

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 (Food)·F-0206-2023·2022-12-28
Red Button French Silk Pies Recalled for Undeclared Almonds
Rocky Mountain Pies is recalling Red Button Vintage Creamery French Silk Pies because some contain Turtle Cream Pies with almonds not declared on the label. Consumers with almond allergies are at risk.
Product
Red Button Vintage Creamery French Silk Pie, Net Wt. 31.88 oz. (904g), in a clear plastic dome and black plastic base, UPC 0 41172 81290 9, Distributed By: Associated Food Stores, Salt Lake City, Utah 84119 RMYA0421" printed on sleeve. Keep refrigerated.
Category
Food
Distribution
9 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
HighFDA (Devices)·Z-0733-2023·2022-12-28
GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Altitude
GE Healthcare is recalling B125M patient monitors because the CO2 measurement display can be inaccurate at locations above sea level when configured for mmHg or kPa units.
Product
B125M Patient Monitor, REF 6160000-005-XXXXXXX
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0752-2023·2022-12-28
GE Vivid S5 Ultrasound Systems Battery Failure Fire Risk
GE Medical Systems is recalling Vivid S5 ultrasound systems because batteries may fail if not replaced at the recommended 2-year intervals, potentially causing smoke or fire.
Product
Vivid S5 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-0740-2023·2022-12-28
Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Positive Results
Abbott Molecular is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit due to reports of false positive results and reactive negative controls. No illnesses or injuries have been reported.
Product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Category
Medical Device
Distribution
0 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 (Food)·F-0198-2023·2022-12-28
Circle K frozen pizza dough recalled for foreign object contamination
Circle K 22 oz Blonde Pizza Dough balls are being recalled due to potential contamination with foreign objects from packaging. Consumers with affected lots should not consume the product.
Product
Circle K 22 oz Blonde Pizza Dough balls, 20 ct/case; frozen pizza dough
Category
Food
Distribution
5 states
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0088-2023·2022-12-28
Prescription Drug Quinapril Recalled for Chemical Impurity Exceeding Safety Limits
Lupin Pharmaceuticals is recalling Quinapril 40mg tablets due to detection of N-Nitroso-quinapril impurity above acceptable daily intake limits. The recall affects approximately 30,612 bottles distributed nationwide.
Product
QUINAPRIL — QUINAPRIL (QUINAPRIL)
Category
Drug
Distribution
Distributed nationwide
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-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…
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