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 13748

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-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-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-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-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-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-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-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-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
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
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-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
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-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
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-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-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-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
HighFDA (Devices)·Z-0161-2023·2022-11-09
Surgical Cataract Packs with Compromised Breather Pouch Seals Recalled
Medline recalls 708 Bausch + Lomb cataract surgical packs due to breather pouch seal defects that could compromise sterility of surgical instruments.
Product
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2023·2022-11-09
Beach Chair Clamp Shoulder Positioner recalled for adhesive curing failure
Baxter Healthcare recalls Beach Chair Clamp shoulder positioner components because adhesive on the fasteners may not cure properly, potentially reducing the device's mechanical integrity during surgical procedures.
Product
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0163-2023·2022-11-09
Medline LINQ Surgical Trays Recalled for Compromised Pouch Seals
Medline has recalled LINQ TRAY surgical kits with breather pouch seal openings that could compromise sterility. The recall affects 40 kits distributed nationwide; no injuries have been reported.
Product
MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0159-2023·2022-11-09
Surgical eye kits recalled for breached sterile pouches
Medline Industries recalls Bausch + Lomb eye muscle surgical kits due to breached breather pouches that may compromise sterility. The affected kits (Lot 22DBN366) were distributed nationwide.
Product
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2023·2022-11-09
Surgical Cataract Kits Recalled for Defective Breather Pouch Seals
Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.
Product
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2023·2022-11-09
Cardiac Navigation Catheter Recalled for Cellulose Fiber Contamination
Johnson & Johnson is recalling 91 THERMOCOOL SMARTTOUCH SF cardiac catheters nationwide due to manufacturing defects introducing cellulose fibers into the irrigation system. The contamination may prevent proper flushing, reduce cooling capability, or cause clotting complications.
Product
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.
Category
Medical Device
Distribution
Distributed nationwide

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10776–10800 of 13748