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

10626–10650 of 89674

HighFDA (Devices)·Z-3284-2024·2024-10-02
Esophageal Stent Systems Recalled Due to Catheter Detachment Risk
Boston Scientific is recalling Wallflex and Agile esophageal stent systems worldwide due to the potential for delivery catheter tip detachment during placement. The recall affects 133 units distributed globally.
Product
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3267-2024·2024-10-02
Boston Scientific esophageal stents recalled due to catheter tip detachment risk
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential detachment of the delivery catheter tip during stent placement. These devices are used to maintain patency in esophageal strictures caused by malignant tumors or esophageal fistulas.
Product
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3209-2024·2024-10-02
Ultrasonic Cleaner Solution Recalled for Bacterial Contamination and Infection Risk
Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.
Product
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3271-2024·2024-10-02
WallFlex Esophageal Stent System Recalled for Potential Catheter Tip Detachment
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.
Product
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esop
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3187-2024·2024-10-02
Roche Creatine Kinase test reagents recalled for calibration errors
Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.
Product
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3244-2024·2024-10-02
Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Product
Pacemaker, COPM11B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3262-2024·2024-10-02
Airvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery
Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.
Product
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-3266-2024·2024-10-02
WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
Product
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3283-2024·2024-10-02
Wallflex and Agile Esophageal Stent Systems Recalled for Potential Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3226-2024·2024-10-02
Medical Pacemaker Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.
Product
PACEMAKER PACK, SLCV01J; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3247-2024·2024-10-02
BD Phoenix diagnostic systems may misidentify E. coli in clinical samples
The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.
Product
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3216-2024·2024-10-02
ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
Product
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Category
Medical Device
Distribution
42 states
HighFDA (Drugs)·D-0663-2024·2024-10-02
Pyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
Product
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3081-2024·2024-10-02
GE Panda iRES infant warmer electrical safety testing incomplete
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
Product
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-010
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3275-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent e
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3204-2024·2024-10-02
MRI Diagnostic Device Loose Screws May Block Patient Tabletop
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
Product
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3302-2024·2024-10-02
Cardinal Health Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
Product
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0660-2024·2024-10-02
Mupirocin Antibiotic Ointment Recalled Nationwide Due to Subpotency
Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.
Product
MUPIROCIN — MUPIROCIN (MUPIROCIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3255-2024·2024-10-02
Biodesign Fistula Plug Implants Recalled Due to Premature Expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
Product
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3218-2024·2024-10-02
Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3280-2024·2024-10-02
FDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3212-2024·2024-10-02
Cervical disc replacement recalled for foreign contamination in assembly
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0665-2024·2024-10-02
Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach
Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.
Product
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3299-2024·2024-10-02
Arrow Arterial Kits Recalled Due to Open Packaging Seals
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
Product
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3265-2024·2024-10-02
Esophageal stent system recalled due to potential delivery catheter detachment
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
Product
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
Category
Medical Device
Distribution
Distributed nationwide

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10626–10650 of 89674