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 the agency’s own highest classification or reported deaths or serious injuries, 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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40226–40250 of 40356

  • HighFDA (Devices)·Z-1922-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

    DePuy Orthopaedics is recalling Luster and Ultima LX hip stems implanted with metal-on-metal articulations due to a field safety notice.

    Product
    LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Use

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Components

    DePuy Orthopaedics issued a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2012·2012-07-11

    DePuy Recalls Cemented Polished Femoral Hip Stems Due to Metal-on-Metal Use

    DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2012·2012-07-11

    Thayer Medical Recalls AirLife MiniSpacer MDI Adapters Due to Molding Defect

    Thayer Medical is recalling 19,340 AirLife MiniSpacer MDI adapters due to a molding defect that may result in incomplete filling of the aerosol dispensing pathway.

    Product
    AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1942-2012·2012-07-11

    Philips Xcelera Connect Software Recalled for Incomplete Data Exchange

    Philips Healthcare is recalling 226 units of Xcelera Connect software because unformatted reports may result in incomplete information arriving at the interface.

    Product
    Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2012·2012-07-11

    Pride Mobility Victory 9 Wheelchair Recalled for Harness Sealing Defect

    Pride Mobility is recalling 186 Victory 9 motorized wheelchairs because the main harness connector lacks required back shield sealing, allowing water to seep through.

    Product
    Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1943-2012·2012-07-11

    Integra Recalls Single Shot Epidural Trays Missing Injectable Components

    Integra LifeSciences is recalling one lot of Single Shot Epidural Trays because they were shipped without required injectable components.

    Product
    Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1884-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some cannula tips that can be dislodged.

    Product
    X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1827-2012·2012-07-04

    Fresenius GranuFlo Acid Concentrate Recalled for Risk of Alkalosis

    Fresenius Medical Care is recalling GranuFlo Acid Concentrate due to a risk of alkalosis in patients undergoing hemodialysis.

    Product
    Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1830-2012·2012-07-04

    Arrow Central Venous Catheter Recall for Labeling Inconsistency

    Arrow International is recalling 634,912 central venous catheter sets because the product label states 'contains no medication' while the insert indicates the product is medicated.

    Product
    Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1826-2012·2012-07-04

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Alkalosis Risk

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate due to a risk of alkalosis. The product is used for hemodialysis.

    Product
    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1883-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface of some tips can be dislodged.

    Product
    X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1893-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some cannula tips that could dislodge.

    Product
    CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2012·2012-07-04

    Hartmann Sterile Gauze Sponges Recalled for Sterile Barrier Defects

    Hartmann USA is recalling specific lots of Econolux sterile gauze sponges because micro holes were detected in the sterile barrier system, potentially compromising sterility.

    Product
    Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance found on the inner surface of some tips can be dislodged during use.

    Product
    Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some tips that could dislodge.

    Product
    CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2012·2012-07-04

    Ethicon Surgiflo Hemostatic Matrix Kit Recalled for Potential Non-Sterility

    Ethicon is recalling Surgiflo Hemostatic Matrix Kits with Thrombin because an undetected air leak during manufacturing may have compromised the sterility of the thrombin component.

    Product
    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance on the cannula tips can be dislodged during use.

    Product
    CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulae because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide