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 5027

SevereFDA (Devices)·Z-2854-2026·2026-08-12
Copan WASPLab Software Recall Over Results Overwrite Issue
Copan WASP is recalling WASPLab devices due to a software issue in the WebApp that may prevent users from overwriting results. The recall affects WebApp versions 2.33.1, 2.33.3, and 2.34.2.
Product
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked w
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-2843-2026·2026-08-12
Powered Wheelchair Controller Software Recall by Pride Mobility
Pride Mobility is recalling 1,102 Q6 Edge 3 Stretto 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: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto 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-2835-2026·2026-08-12
Therabody Theragun G4 PRO Charger Recalled for Fire Risk
Therabody is recalling Theragun G4 PRO chargers because they may overheat, presenting a risk of fire, smoke, or melting.
Product
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger. G4 PRO Black US - Refurb., SKU TG02428-01 G4 PRO NA, SKU G4-PRO-PKG-NA G4-PRO-PKG-US, SKU G4 PRO US G4 PRO Black US - Refurb V, SKU TG0002428
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2889-2026·2026-08-12
Beckman Coulter MicroScan Panel Update DVD Kits Recalled
Beckman Coulter is recalling MicroScan LabPro V5.03 Panel Update 11 DVD Kits due to incorrect algorithms that may affect antimicrobial susceptibility test results, potentially leading to false susceptibility classifications.
Product
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan Walk
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2850-2026·2026-08-12
Quantum Rehab Q6 Edge 4 Wheelchairs Recalled Due to Controller Software Issue
Pride Mobility Products Corp. is recalling Quantum Rehab Q6 Edge 4 powered wheelchairs because a software issue can cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 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
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
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
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
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
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-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-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-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-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-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-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-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-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-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-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-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

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