The Recall Desk

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.

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

7151–7175 of 13683

  • ModerateFDA (Devices)·Z-1192-2024·2024-03-06

    Dental Prosthetic Material Recall for Machining Defects

    GRAPHENANO Dental G-CAM denture manufacturing material is being recalled due to machining errors that render the product unusable. The recall affects 354 units distributed in Utah.

    Product
    GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1188-2024·2024-03-06

    Abbott in-vitro diagnostic kits shipped without U.S. approval or registration

    Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.

    Product
    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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-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-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-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-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-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-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
  • HighFDA (Devices)·Z-1171-2024·2024-02-28

    Cardiology imaging software may calculate heart chamber size incorrectly

    Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.

    Product
    Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2024·2024-02-28

    Epidural Tray Kits Recalled for Wrong Connector Type

    B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.

    Product
    Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anestheti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2024·2024-02-28

    Automated Impella Controller Software Update Resolves Pump Recognition Issue

    Abiomed is releasing software Version 8.5 for the Automated Impella Controller to fix an issue in versions 8.4 and 8.4.1 where the device failed to recognize the pump. Approximately 4,463 units were distributed nationwide.

    Product
    Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2024·2024-02-28

    OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy

    The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.

    Product
    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2024·2024-02-28

    Philips Azurion X-ray Systems Disk Bay May Fail and Prevent Imaging

    The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2024·2024-02-28

    Patterson Procedure Earloop Masks Recalled Due to Non-Validated Production Equipment

    Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.

    Product
    PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2024·2024-02-28

    3M Surgical Blade Assembly Recalled for Burn Injury Risk During Use

    3M is recalling the Specialty Blade Assembly (REF 9660) used with 3M Surgical Clippers worldwide due to burn risk if the blade overheats during operation. Approximately 52.8 million units affected across all lot codes.

    Product
    3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
    Category
    Medical Device
    Distribution
    0 states