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

10851–10875 of 13816

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
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
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-0187-2023·2022-11-16
Cardinal Health Reusable Gel Pack Restricted for Infants
Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.
Product
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
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-0197-2023·2022-11-16
Orthopedic Surgical Blade Recall Due to Incorrect Configuration
Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.
Product
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
Category
Medical Device
Distribution
7 states
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-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
HighFDA (Devices)·Z-0198-2023·2022-11-16
Canon Aplio Ultrasound Systems Software Defect May Misassign Patient Images
Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.
Product
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0182-2023·2022-11-16
Sedecal Soltus Battery Mobile X-Ray Systems Recalled for Unintended Movement
Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.
Product
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-0184-2023·2022-11-16
FERNO POWER X1 ambulance cot batteries pose fire and burn risk
Ferno-Washington is recalling 1,922 FERNO POWER X1 ambulance cots with 36V Li-Ion batteries that may become unstable and pose a fire or burn injury risk if dropped, power washed, or abused.
Product
FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).
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-0185-2023·2022-11-16
Reusable gel pack recalled due to infant use contraindication
Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.
Product
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Category
Medical Device
Distribution
Distributed nationwide
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-0193-2023·2022-11-16
Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerability
Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.
Product
Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
Category
Medical Device
Distribution
54 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-0189-2023·2022-11-16
Cardinal Health Insulated Gel Pack Recalled for Infant Safety
Cardinal Health is recalling its insulated gel pack because it should not be used on infants or neonates. The product labeling will be updated with a caution statement.
Product
Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
Category
Medical Device
Distribution
Distributed nationwide
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-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
ModerateFDA (Devices)·Z-0220-2023·2022-11-16
Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.
Product
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0196-2023·2022-11-16
Alphatec Spine Disc Preparation Instruments Recalled for Regulatory Non-Compliance
Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.
Product
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827 CI-1105
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0192-2023·2022-11-16
Cardinal Health Reusable Gel Pack Recalled for Unsafe Infant Use
Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.
Product
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0181-2023·2022-11-16
Dialysis concentrate labeling error for chemical composition
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.
Product
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Category
Medical Device
Distribution
21 states

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10851–10875 of 13816