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

251–275 of 27298

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-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-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-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-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-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
HighFDA (Devices)·Z-2726-2026·2026-07-22
GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
GE HealthCare recalls certain Optima XR200/220/240amx mobile radiographic systems where safety testing may have been incomplete after column replacement. A failed counterpoise cable could cause the X-ray arm to drop on patients.
Product
Optima XR200amx, Mobile Digital-Ready Radiographic System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2728-2026·2026-07-22
Mobile Digital Radiographic System Arm Drop Risk During Patient Exams
GE HealthCare is recalling certain Optima XR200/220/240amx Mobile Digital Radiographic Systems due to potential failure of the Column Safety mechanism, which could cause the X-ray arm to drop during patient exams. The issue stems from incomplete functional testing of the safety pawl after column replacement.
Product
Optima XR240amx, Mobile Digital Radiographic System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2721-2026·2026-07-22
Olympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
Olympus Corporation is recalling the Glass Body for 194 Ellik Evacuator (Model 190A) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
Product
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2719-2026·2026-07-22
Olympus Toomey Evacuator 50cc with Adaptor sterilization recall
Olympus is recalling the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization parameters in the instructions may not reliably render the devices sterile.
Product
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
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-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
HighFDA (Devices)·Z-2730-2026·2026-07-22
Orthofix MINIRAIL external fixation devices recalled for incorrect labeling
Orthofix U.S. LLC is recalling 19 units of Orthofix MINIRAIL orthopedic external fixation devices distributed across the US due to incorrect model labeling that could lead to surgical use of the wrong device.
Product
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2741-2026·2026-07-22
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
Maquet Cardiovascular is recalling Vasoview Hemopro 2 devices from Lot 3000547797 due to exposure to out-of-specification sterilization during gamma sterilization. The affected devices may not be properly sterilized.
Product
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
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-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
SevereFDA (Devices)·Z-2711-2026·2026-07-15
Brachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
Elekta, Inc. is recalling Advanced Gynecological Applicators due to potential detachment of the intrauterine tube tip, which may remain inside a patient during cancer treatment.
Product
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2712-2026·2026-07-15
Elekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.
Product
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2710-2026·2026-07-15
Fletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.
Product
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2716-2026·2026-07-15
TMINI Tracking Array knob loosening causing potential array misalignment
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays used in knee replacement surgery because the knob on the tracking array may loosen, causing potential misalignment of the array.
Product
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2694-2026·2026-07-15
Intracept Access Instruments sterile barrier breach risk
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
Product
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2698-2026·2026-07-15
MiniMed 780G Insulin Pump Software Anomaly Recall
Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.
Product
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2703-2026·2026-07-15
Atellica CH Enzymatic Hemoglobin A1c assay well-to-well bias
Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Category
Medical Device
Distribution
Distributed nationwide

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251–275 of 27298