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

10776–10800 of 13717

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-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-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-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
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-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-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
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
CriticalFDA (Devices)·Z-0153-2023·2022-11-09
CritiCool Thermoregulation Device Recalled Due to Pump Failure
The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.
Product
CritiCool, thermoregulation device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0141-2023·2022-11-09
Hillrom Centrella Hospital Bed Radio Frequency Emissions May Interfere with Medical Devices
Hillrom Centrella Hospital Beds with WatchCare systems may emit radio frequency signals that interfere with other medical devices. Approximately 6,407 units are affected and distributed in the US.
Product
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7900B100259, P7900B100264, P7900B100268, P7900B100269, P7900B
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0144-2023·2022-11-09
Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System (63 units in US) because radio frequency emissions from the device may interfere with other medical equipment including infusion pumps and insulin pumps.
Product
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0143-2023·2022-11-09
Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System for Progressa Bed due to potential radio frequency emissions that may interfere with other medical devices including telemetry monitors and infusion pumps.
Product
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0145-2023·2022-11-09
Hillrom WatchCare Incontinence System Recalled for Radio Frequency Emissions
Baxter Healthcare is recalling 129 units of the Hillrom WatchCare incontinence management system due to radio frequency emissions that may interfere with other hospital medical devices such as telemetry units, fetal monitors, and insulin pumps.
Product
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0142-2023·2022-11-09
Hillrom WatchCare Incontinence System recalled for radio frequency interference risk
Baxter Healthcare is recalling the Hillrom WatchCare Incontinence Management System due to radio frequency emissions that may interfere with other critical medical devices including insulin pumps and fetal monitors.
Product
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0148-2023·2022-11-09
Transcutaneous monitor attachment rings recalled for weak skin adhesion
SenTec AG voluntarily recalled 17,208 units of transcutaneous CO2/O2 monitor attachment rings due to weak skin adhesion. The devices, used in noninvasive patient monitoring, were distributed nationwide.
Product
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2023·2022-11-09
Operating Room Table With Defective Adhesive May Lose Mechanical Integrity
Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.
Product
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0152-2023·2022-11-09
Implantable Defibrillator Software Error Causes Inaccurate Battery Display
Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.
Product
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0147-2023·2022-11-09
Fogarty Biliary Balloon Probes recalled for latex deterioration
Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.
Product
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0162-2023·2022-11-09
Medline Lithotomy Sterile Surgical Kit Recalled for Compromised Breather Pouch Seal
Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.
Product
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2023·2022-11-09
BD Trucount Tubes for Blood Testing Recall Due to Label Detachment
Becton, Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together or create automation errors. The defect stems from an adhesive supplier change and affects 52,570 units.
Product
BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the B
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0146-2023·2022-11-09
Fogarty Arterial Embolectomy Catheters Recalled for Latex Deterioration
Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.
Product
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2023·2022-11-09
Surgical Kit Sterile Pouches with Seal Openings Recalled by Medline
Medline is recalling approximately 160 surgical kits with defective breather pouches showing seal openings, potentially compromising sterility. The recall affects facilities in eight states nationwide.
Product
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2023·2022-11-09
Surgical Eye Kit Pouches Recalled for Seal Defects
Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.
Product
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2023·2022-11-09
Baxter Neurosurgical Headrest Recalled Due to Defective Adhesive
Baxter Healthcare is recalling C-Flex Polar Head Positioning Device neurosurgical headrests because adhesive on fasteners may not cure correctly, potentially compromising mechanical integrity and holding force.
Product
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0166-2023·2022-11-09
Medline CVC Barrier Kit Recalled for Breached Pouch Seals
Medline is recalling CVC barrier kits (Lot 22ABT774) due to breather pouches with seal openings that could compromise sterility of the surgical kit contents.
Product
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide

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10776–10800 of 13717