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

301–325 of 39923

SevereFDA (Devices)·Z-2683-2026·2026-07-22
ABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall
ABIOMED Impella CP Introducer Kit 14Fr is being recalled 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 Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
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-2720-2026·2026-07-22
Olympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
Olympus Corporation of the Americas is recalling the Olympus Ellik Evacuator (Model 194) worldwide because certain sterilization parameters in the instructions may not render the device adequately sterile.
Product
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2707-2026·2026-07-22
T-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.
Product
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
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-2685-2026·2026-07-22
Abiomed Impella CP Introducer Kit heart pump accessory recall
Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.
Product
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2679-2026·2026-07-22
Abiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.
Product
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2686-2026·2026-07-22
ABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.
Product
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2724-2026·2026-07-22
ICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
ICU Medical is recalling the Plum Solo Precision IV Pump (v1.0.3) because in specific scenarios, the pump may fail to decrease the displayed volume and could deliver up to twice the programmed medication amount.
Product
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
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
SevereFDA (Devices)·Z-2688-2026·2026-07-22
Abiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk
Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.
Product
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2684-2026·2026-07-22
ABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
Abiomed is recalling ABIOMED Introducer Kit 23 Fr due to potential sheath leakage from manufacturing defects. The leakage risk is not visually detectable and affects all current batches worldwide.
Product
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2689-2026·2026-07-22
ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.
Product
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2678-2026·2026-07-22
Abiomed Impella Introducer Kit Recalled Due to Potential Leakage
Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.
Product
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2706-2026·2026-07-22
General Biopsy Tray with Lidocaine HCL Injection subject to sterility recall
Argon Medical Devices is recalling General Biopsy Tray kits containing Lidocaine HCL Injection because the kits do not meet sterility release criteria.
Product
General Biospy Tray, REF: GUTS1000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2709-2026·2026-07-22
Bone Marrow Tray kits recalled due to sterility failure
Argon Medical Devices is recalling Bone Marrow Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria.
Product
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
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-2739-2026·2026-07-22
Medtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
Medtronic is recalling its Bio-Medicus Adult Cannula Kit (Product Number 96530-115) used in cardiopulmonary bypass procedures due to the discovery of loose foreign material containing trace levels of blood in two units.
Product
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
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-2693-2026·2026-07-22
ABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk
Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.
Product
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2026·2026-07-22
Olympus Toomey Evacuator 30cc medical device sterilization parameters recalled
Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
Product
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2738-2026·2026-07-22
Medtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
Medtronic is recalling certain DLP One-Piece Pediatric Arterial Cannulas (Product Number 77010) due to complaints of loose foreign material containing trace levels of blood found in the devices.
Product
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2725-2026·2026-07-22
Rapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) is being recalled because the recalled Medline Namic Angiographic Control Syringe may loosen or disconnect from the manifold, potentially causing leakage, inability to aspirate or inject, and procedure delays.
Product
Rapid Refill Continuous Injection System, UPN M00566001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2727-2026·2026-07-22
GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
GE Medical Systems is recalling certain Optima XR200/220/240amx mobile radiographic systems after column replacements because functional testing of the safety pawl may not have been performed, which could allow the X-ray arm to drop and injure patients.
Product
Optima XR220amx, Mobile Digital-Ready Radiographic System
Category
Medical Device
Distribution
Distributed nationwide

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