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

526–550 of 1396

CriticalFDA (Devices)·Z-1046-2024·2024-02-28
Dover Foley catheter kits recalled due to defective supplier components
Cardinal Health is recalling Dover brand Foley catheter kits due to components recalled by supplier Nurse Assist. Approximately 435,060 units were distributed to the US, Europe, Japan, and Latin America.
Product
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1081-2024·2024-02-28
Surgical ocular pack kits recalled due to saline sterility assurance loss
Windstone Medical Packaging is recalling 80 Aligned Medical Solutions ocular pack surgical kits because sterility of the included saline cannot be guaranteed.
Product
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1051-2024·2024-02-28
Cardinal Health Foley Catheter Kits Recalled Over Supplier Component Defect
Cardinal Health is recalling 36,300 Foley urinary drainage convenience kits due to components that were subsequently recalled by supplier Nurse Assist.
Product
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1052-2024·2024-02-28
Dover Foley Catheter Kits and Drain Trays Recalled
Dover Foley catheter kits and silicone drain trays manufactured with subsequently recalled components were distributed to 924 units across the US, EMEA, Japan, and Latin America.
Product
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1043-2024·2024-02-28
Argyle Suction Catheter Trays with Chimney Valve recalled for defective components
Cardinal Health is recalling multiple Argyle Suction Catheter Tray models due to defective components. The kits containing these recalled components were distributed in the US, Europe, Japan, and Latin America.
Product
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction Cathet
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1001-2024·2024-02-28
Baxter Exactamix Pro 1200 Software Error Causes Medication Over-delivery
Baxter Healthcare is recalling the Baxter Exactamix Pro 1200 medication compounding device due to a software error that may cause ingredient over-delivery when using the 'Use Some Overfill' feature.
Product
Baxter Exactamix Pro 1200, REF EXM12DY
Category
Medical Device
Distribution
22 states
SevereFDA (Devices)·Z-1080-2024·2024-02-28
Surgical ocular packs recalled for loss of saline sterility
Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.
Product
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1049-2024·2024-02-28
Dover Irrigation Convenience Kits Recalled for Component Defects
Cardinal Health is recalling Dover Irrigation convenience kits that contained components which were separately recalled. The recall affects over 63,000 units distributed across the US, EMEA, Japan, and Latin America.
Product
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1079-2024·2024-02-28
Surgical Kit with Saline Recalled Over Sterility Assurance Issue
Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.
Product
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1044-2024·2024-02-28
Tracheostomy Supply Kits Recalled for Defective Components
Cardinal Health is recalling 661,560 tracheostomy kits because they were manufactured with components that were subsequently recalled by another manufacturer.
Product
TRACH KIT W/HYDROGEN & SALI
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1050-2024·2024-02-28
Dover Foley Catheter Kits Recalled Due to Defective Components
Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.
Product
Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML D
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1002-2024·2024-02-28
Baxter Exactamix Pro 2400 Recalled for Software Error Causing Ingredient Over-Delivery
Baxter is recalling Exactamix Pro 2400 pharmacy mixing devices due to a software error in versions 2.0.8 and 2.1.8 that may cause over-delivery of ingredients.
Product
Baxter Exactamix Pro 2400, REF EXM24DY
Category
Medical Device
Distribution
22 states
SevereFDA (Devices)·Z-1045-2024·2024-02-28
Dover Foley Catheter and Urinary Drainage Kits Recalled for Defective Components
Cardinal Health is recalling Dover foley catheter and urinary drainage kits containing components previously recalled by supplier Nurse Assist. The FDA Class I recall affects 17,640 units distributed to the US, EMEA, Japan, and Latin America.
Product
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILL
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1047-2024·2024-02-28
Dover Foley catheters recalled due to defective supplied components
Cardinal Health Dover Foley catheters (7,800 units distributed in the US, EMEA, Japan, and Latin America) are being recalled because convenience kits were manufactured with components previously recalled by Nurse Assist.
Product
Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1048-2024·2024-02-28
Dover Foley catheter convenience kits recalled due to component defects
Cardinal Health is recalling Dover-branded Foley catheter convenience kits with components that were subsequently recalled by Nurse Assist. The recall affects 195,600 units distributed in the US, EMEA region, Japan, and Latin America.
Product
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, D
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1082-2024·2024-02-28
Medical Closure Kit Recall: Sterility of Saline Cannot Be Guaranteed
Windstone Medical Packaging is recalling Aligned Medical Solutions Closure Kits due to inability to guarantee sterility of included saline. This FDA Class I recall affects 475 units distributed in Florida, Illinois, and California.
Product
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0962-2024·2024-02-21
GE Healthcare Lullaby Incubator bedside panels may fail to latch properly
GE Healthcare Lullaby Incubator bedside panels and portholes may appear closed but not be properly latched. If impacted, these panels can disengage and fall open, creating a fall risk for patients.
Product
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0958-2024·2024-02-21
GE Healthcare Care Plus and Lullaby incubators recalled for bedside panel latching defect
GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.
Product
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0980-2024·2024-02-21
Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation
Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.
Product
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0960-2024·2024-02-21
GE Healthcare incubator bedside panel may disengage and fall open
The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.
Product
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0961-2024·2024-02-21
GE Healthcare Incubators Bedside Panel Latch Failure Poses Fall Risk
GE Healthcare incubators have defective bedside panels that may appear closed but not be properly latched, creating a patient fall risk when the panels disengage upon impact.
Product
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0959-2024·2024-02-21
GE Healthcare Care Plus Incubator Hood Latching Defect Increases Fall Risk
GE Healthcare incubator hoods can appear closed but may not be properly latched, posing a fall risk if patients impact an unsecured panel.
Product
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0957-2024·2024-02-21
GE Healthcare neonatal incubator bedside panels may fail to latch properly
GE Healthcare is recalling neonatal incubators because the bedside panel can appear closed while unlatched. Impact could cause it to fall open, risking patient injury.
Product
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0857-2024·2024-02-14
Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
Product
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0855-2024·2024-02-14
Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes
Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.
Product
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Category
Medical Device
Distribution
Distributed nationwide

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526–550 of 1396