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

26–50 of 5100

SevereFDA (Devices)·Z-2891-2026·2026-08-12
Philips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives
Philips is recalling 5,012 Allura interventional fluoroscopic X-ray systems nationwide due to potential loss of imaging functionality, motorized movement, or data caused by unauthorized hard disk drives.
Product
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2909-2026·2026-08-12
Blom-Singer Voice Prosthesis Boxes Mislabeled with Wrong Flange Type
Freudenberg Medical is recalling 12 Blom-Singer Classic Indwelling Voice Prosthesis devices because the boxes are mislabeled, swapping Large Esophageal Flange and Large Esophageal and Tracheal Flange contents.
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2852-2026·2026-08-12
Quantum Rehab 4Front Powered Wheelchair Controller Software Recall
Pride Mobility is recalling 1,102 Quantum Rehab 4Front powered wheelchairs with controller software version 2.0.11 due to a defect that may cause unexpected brake stops or control system crashes.
Product
Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2840-2026·2026-08-12
Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.
Product
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2876-2026·2026-08-12
GE Healthcare MAC VU360 Electrocardiograph Software Recall
GE Healthcare is recalling 163 MAC VU360 electrocardiograph units due to a software issue that may cause a previous patient's data to remain visible and be incorrectly associated with a subsequent patient.
Product
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2792-2026·2026-08-05
Cardiovascular Procedure Kits Recalled Due to Particulate in Fluid Path
Medical Action Industries is recalling cardiovascular procedure kits containing manifolds that may have particulate in the fluid path, which could enter blood circulation and lodge in blood vessels. FDA Class I.
Product
Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-2735-2026·2026-08-05
ResMed Astral 100/150 Ventilators Recalled Due to Electrolyte Leakage Risk
ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.
Product
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2819-2026·2026-08-05
Medical Convenience Kits Recalled Over Lidocaine Injection Supplier Quality Issues
Windstone Medical Packaging is recalling 15 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues reported by Elevaris Medical Devices Inc.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2807-2026·2026-08-05
Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.
Product
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2809-2026·2026-08-05
Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula Model 77722 due to potential pinhole leaks in the wire-wound body during use.
Product
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2748-2026·2026-07-29
Medline C-Section Convenience Kits Recalled Due to Quality Issues in Bupivacaine Component
Medline Industries, LP is recalling specific C-Section convenience kits because they contain Bupivacaine Hydrochloride in Dextrose Injection, USP, which is subject to a voluntary recall due to quality issues.
Product
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-2747-2026·2026-07-29
Medline Anterior Hip Kits Recalled Due to Quality Issues in Bupivacaine Injection
Medline Industries, LP is recalling specific Medline kits containing B. Braun convenience kits because they include Bupivacaine Hydrochloride in Dextrose Injection, USP, which has been recalled due to quality issues.
Product
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-2749-2026·2026-07-29
Medline Orthopedic Surgery Kits Recalled Over Bupivacaine Quality Issue
Medline Industries, LP is recalling 2301 convenience kits used in orthopedic joint procedures because they contain B. Braun kits with Bupivacaine Hydrochloride in Dextrose Injection, USP, which the manufacturer Huons Co, Ltd. voluntarily recalled due to quality issues.
Product
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J;
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-2760-2026·2026-07-29
FDA Recalls Power F2 Fastening Systems Over Rail Wear Risk
The FDA is recalling 278 Power F2 Powered Fastening Systems made by Ferno-Washington Inc due to potential roller wear and rail deformation that could prevent stretcher movement.
Product
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 0567091
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2756-2026·2026-07-29
Boston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk
Boston Scientific is recalling FARADRIVE STEERABLE SHEATH (CLEAR) because improper dilator insertion can damage the hemostatic valve, potentially leading to air ingress and air embolism.
Product
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2764-2026·2026-07-29
Medline Medical Procedure Convenience Kits Recalled Due to Potential Drug Ineffectiveness
Medline Industries, LP is recalling certain MEDLINE medical procedure convenience kits because they contain ICU Medical, Inc. pain management kits that may be ineffective.
Product
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2765-2026·2026-07-29
MEDLINE Medical Procedure Kits Containing Bupivacaine Recalled Due to Drug Ineffectiveness
Medline Industries is recalling 318 medical procedure kits that contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection due to quality issues that could result in drug ineffectiveness.
Product
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP CDS-LF, Medline kit SKU CDS984556L; 5) HIP CDS-LF, Medline kit SKU CDS9845
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2708-2026·2026-07-22
Arterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.
Product
Arterial Line Kit 20ga x 6, REF: 400115A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2705-2026·2026-07-22
One-Piece Introducer Tray kits recalled for sterility failure
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
Product
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2681-2026·2026-07-22
ABIOMED Impella RP Flex heart pump introducer sheath leakage risk
Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.
Product
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2682-2026·2026-07-22
ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.
Product
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2692-2026·2026-07-22
ABIOMED Insertion Kit heart pump accessories introducer sheath leakage
Abiomed is recalling ABIOMED Insertion Kits due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
Product
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2723-2026·2026-07-22
ICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.
Product
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2691-2026·2026-07-22
ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.
Product
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2687-2026·2026-07-22
ABIOMED Impella 5.5 Heart Pump Introducer Sheath Leakage Risk Recall
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
Product
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide

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