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

1–25 of 126

CriticalFDA (Devices)·Z-2604-2026·2026-07-08
Omnipod DASH Pod insulin pump affected by external cannula damage
Insulet Corporation is recalling Omnipod DASH Pods worldwide due to external soft cannula damage during manufacturing that can cause insulin to leak around the pod instead of being delivered. This may lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.
Product
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1935-2026·2026-05-13
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Product
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip co
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1934-2026·2026-05-13
Cook Centimeter Sizing Catheter recall due to marker band cracking
Cook Incorporated is recalling Centimeter Sizing Catheters because marker bands may crack or break, potentially causing device fragmentation, vessel injury, or life-threatening harm.
Product
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2031-2026·2026-05-06
Insulin Pump Batteries Recalled After Sudden-Shutdown Reports
OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1289-2025·2025-03-19
Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter
Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.
Product
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1257-2025·2025-03-12
Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
Product
Paradigm insulin pump, REF: MMT-754
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1244-2025·2025-03-12
Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk
Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.
Product
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1152-2025·2025-02-26
Philips Allura Xper Patient Table Mattress Defect Fall Risk
Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.
Product
Allura Xper FD10C; Catalog number: 722001
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1144-2025·2025-02-26
Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk
Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.
Product
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1070-2025·2025-02-26
Vascular Tack Endovascular System recalled for deployment and migration risks
Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.
Product
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0825-2025·2025-01-22
ALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
Product
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0887-2025·2025-01-22
Life2000 Ventilation System battery charger defect causes device inoperability
Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.
Product
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0830-2025·2025-01-22
Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
Product
Impella RP Flex with SmartAssist; Product Number: 1000323;
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0884-2025·2025-01-22
Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability
The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.
Product
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0382-2025·2024-11-27
Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure
Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0303-2025·2024-11-20
Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk
Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.
Product
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0310-2025·2024-11-20
Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.
Product
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0304-2025·2024-11-20
Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·25046·2024-11-14
Medical King adult bed rails recalled for entrapment and asphyxia hazard
Medical King bed rails (about 222,000 units) are being recalled because they can trap users between the rail and mattress, posing asphyxiation risk. One death has been reported.
Product
Medical King Bed Assist Rail adult bed rails
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0005-2025·2024-10-16
Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect
Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.
Product
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-3084-2024·2024-09-25
Baxter pharmaceutical compounding inlets recalled for particulate matter contamination
Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.
Product
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2943-2024·2024-09-11
Trilogy Evo Ventilator Software Update for Identified Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.
Product
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2606-2024·2024-09-04
Smiths Medical Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2592-2024·2024-09-04
PORTEX Bivona Tracheostomy Tubes Recalled for Flange Tearing Defect
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2636-2024·2024-08-28
McGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion
McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.
Product
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Category
Medical Device
Distribution
Distributed nationwide

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1–25 of 126