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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

27626–27650 of 27722

HighFDA (Devices)·Z-1913-2012·2012-07-11
DePuy Recalls Cemented Polished Femoral Hip Stems Implanted with Metal-on-Metal Articulations
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/3M 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-1934-2012·2012-07-11
Aesculap S4 Cervical Revision Instruments Recalled for Tolerance Issues
Aesculap Implant Systems LLC is voluntarily removing S4 Cervical Revision Instruments because they may not thread into screws properly during surgery.
Product
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1906-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER hip stems implanted with metal-on-metal articulations due to potential safety concerns.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ1 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-1935-2012·2012-07-11
Greiner Bio-One Recalls Vacuette Quickshield Complete Plus Blood Collection Devices
Greiner Bio-One is recalling specific lots of Vacuette Quickshield Complete Plus devices due to a defect that may cause the safety shield to become loose and unstable.
Product
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1933-2012·2012-07-11
Zimmer Recalls PathFinder NXT Pivoting Percutaneous Rod Holder
Zimmer, Inc. is recalling 77 units of the PathFinder NXT Pivoting Percutaneous Rod Holder because the set screw may break, preventing the surgeon from removing the rod during surgery.
Product
PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1924-2012·2012-07-11
DePuy Luster and Ultima Hip Stems Recalled for Metal-on-Metal Use
DePuy Orthopaedics is recalling Luster and Ultima hip stems implanted with metal-on-metal articulations due to a field safety notice.
Product
LUSTER HIP SZ 10 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2012·2012-07-11
DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations
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 4 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-1936-2012·2012-07-11
Microbiologics Recalls KWIK-QC Gram Stain Slides Due to Fixation Defect
Microbiologics is recalling KWIK-QC Gram Stain Slides because the control organism is not properly fixated, which may lead to slide contamination and potential patient misdiagnosis.
Product
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1911-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations due to a Field Safety Notice.
Product
ULTIMA*LX STM,POL 10/12TAP/1M 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-1916-2012·2012-07-11
DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 2 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-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
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

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27626–27650 of 27722