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

40351–40375 of 40480

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-1870-2012·2012-07-04
Colgate Adult Motion Battery Toothbrush Recalled for Battery Cap Defect
Colgate-Palmolive is recalling 6,006 Adult Motion Battery Toothbrushes because the battery cap may blow off the handle.
Product
Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
Category
Consumer Product
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
HighFDA (Devices)·Z-1858-2012·2012-07-04
Hartmann Sterilux Gauze Sponges Recalled for Sterile Barrier Defects
Hartmann USA is recalling Sterilux gauze sponges because micro holes were found in the sterile barrier, potentially compromising sterility.
Product
Hartmann Sterilux Ref 56910000 Sterile Premium 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-1869-2012·2012-07-04
Siemens B12 Reagent Cartridges Recalled for False Test Results
Siemens is recalling B12 Flex reagent cartridges because Intrinsic Factor Blocking Antibodies can cause false high Vitamin B12 results.
Product
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1865-2012·2012-07-04
GE OEC Uroview 2800 Recalled for Intermittent Safety Issues
GE OEC Medical Systems is recalling 717 OEC Uroview 2800 fluoroscopic imaging systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.
Product
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1896-2012·2012-07-04
Philips HeartStart MRx Monitor/Defibrillators Recalled for ECG Failure
Philips is recalling HeartStart MRx monitor/defibrillators because they may fail to display ECG signals, potentially delaying the treatment of cardiac arrhythmias.
Product
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1889-2012·2012-07-04
Terumo Recalls Sarns Cardioplegia Cannula Kits Due to Foreign Substance
Terumo is recalling Sarns Cardioplegia Cannula Kits because a foreign substance was found on the inner surface of some cannula tips that could be dislodged.
Product
CPB CATHETER KIT-DR GERHARDT 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-1882-2012·2012-07-04
Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could dislodge.
Product
X-COATED TRANSPLANT 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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