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

9176–9200 of 27441

HighFDA (Devices)·Z-0216-2023·2022-11-23
Genesis STERRAD Sterilization Containers Fail Aerosol Challenge Testing
CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.
Product
CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0241-2023·2022-11-23
GI4000 Electrosurgical Unit recalled due to power regulator failure risk
Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.
Product
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0244-2023·2022-11-23
Medtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall
Medtronic is recalling 95 units of Visualase Cooled Laser Applicator System devices due to a defect in the outer pouch sterile seal. Affected devices were distributed nationwide to healthcare facilities.
Product
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0229-2023·2022-11-23
125 Series iGO2 Portable Oxygen Concentrator Recalled for Unapproved Adhesive
DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.
Product
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0210-2023·2022-11-23
CareFusion Genesis sterilization containers recalled for failed sterility testing
CareFusion Genesis reusable sterilization containers are recalled after failing aerosol challenge testing requirements. No illnesses or injuries have been reported.
Product
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0207-2023·2022-11-23
CareFusion Genesis Sterilization Containers Fail Required Aerosol Challenge Testing
CareFusion Genesis sterilization containers failed to meet aerosol challenge testing requirements and may not properly sterilize medical instruments.
Product
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0214-2023·2022-11-23
CareFusion Genesis Sterilization Containers Fail Aerosol Challenge Testing
CareFusion Genesis sterilization containers have failed to consistently meet aerosol challenge testing, potentially leaving surgical instruments inadequately sterilized. 318 units distributed in the US and internationally.
Product
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0218-2023·2022-11-23
CareFusion GENESIS Sterilization Containers Recalled for Inadequate Aerosol Challenge Testing
Carefusion 2200 Inc is recalling 562 Genesis STERRAD reusable sterilization containers due to failure to consistently meet aerosol challenge testing requirements, used to sterilize surgical instruments in healthcare facilities.
Product
CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0209-2023·2022-11-23
CareFusion sterilization containers fail aerosol challenge testing
CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The FDA is recalling 510 units to prevent potential sterilization failures.
Product
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0211-2023·2022-11-23
CareFusion sterile containers fail aerosol sterilization test requirement
CareFusion GENESIS sterilization containers did not consistently meet aerosol challenge testing requirements. These containers are used in healthcare facilities to sterilize surgical instruments.
Product
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0221-2023·2022-11-23
Philips Laser System may enter non-recoverable error state
The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.
Product
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-0212-2023·2022-11-23
CareFusion Genesis Sterile Containers Recalled for Failed Sterilization Validation Testing
CareFusion is recalling 308 units of Genesis sterilization containers that failed aerosol challenge testing required to ensure proper sterilization of surgical instruments. The containers were distributed in the US and multiple countries.
Product
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0225-2023·2022-11-16
ORISE Gel Syringe Recall Due to Foreign Body Reaction Risk
Boston Scientific has recalled ORISE Gel Syringe kits used in gastrointestinal endoscopy due to higher incidence of foreign body reactions from remnant gel requiring surgical intervention.
Product
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0226-2023·2022-11-16
Medical Device Procedure Kits Recalled for Foreign Body Reaction Risk
Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher incidence of foreign body reactions to remnant gel post-procedure, which have required surgical intervention in affected patients.
Product
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0224-2023·2022-11-16
Medical Device Recall: ORISE Gel Submucosal Lifting Agent Due to Foreign Body Reactions
Boston Scientific is recalling ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions to retained gel. These reactions caused mass formations requiring surgical intervention.
Product
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0223-2023·2022-11-16
Neonatal Endotracheal Tube Grip with Detachable Metal Clips Recalled
CooperSurgical is recalling NEO-fit Neonatal Endotracheal Tube Grips due to metal clips that can become loose or detach. Eleven complaints include three cases of clip ingestion, three removals from the mouth, and one throat laceration.
Product
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0194-2023·2022-11-16
Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access
MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.
Product
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-0183-2023·2022-11-16
Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update
iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.
Product
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-0222-2023·2022-11-16
X-Guide X-Mark Probe Tool Recall: Missing Weld Creates Aspiration Risk
X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.
Product
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0188-2023·2022-11-16
Cardinal Health Insulated Gel Pack recalled; not safe for infants
Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.
Product
Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2023·2022-11-16
Cardinal Health insulated gel pack recalled for infant contraindication
Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.
Product
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2023·2022-11-16
Scalpel and StatLock in HydroPICC kits expire before label indicates
Access Vascular recalls 79 HydroPICC catheter kits because included scalpel and StatLock components have earlier expiration dates than stated on the package.
Product
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0195-2023·2022-11-16
Sterile Medical Extension Sets Distributed Without Expiration Dates
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
Product
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessor
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0186-2023·2022-11-16
Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates
Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.
Product
Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2023·2022-11-16
Cardinal Health Insulated Gel Pack Reusable Medium Contraindicated for Infant Use
Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.
Product
Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
Category
Medical Device
Distribution
Distributed nationwide

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9176–9200 of 27441