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

27651–27675 of 27722

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
HighFDA (Devices)·Z-1866-2012·2012-07-04
Stryker Endoscopy Recalls Formula Shaver Handpieces Due to Routine Check Concerns
Stryker Endoscopy is recalling 34 Formula and Formula 180 Shaver Handpieces because routine checks to ensure accuracy and fitness for use may not have been adequately determined.
Product
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1877-2012·2012-07-04
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
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) 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-1885-2012·2012-07-04
Terumo Recalls Sarns 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
MAYO MN XCOATED 3/8X1/2 AV 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-1881-2012·2012-07-04
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
XC HEART/LUNG PACK W/SX25RX 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-1859-2012·2012-07-04
Stryker Recalls GoBed+ Model FL20E Hospital Beds Due to Scale Failures
Stryker is recalling 6,325 GoBed+ Model FL20E hospital beds worldwide because loadcell failures can cause scale errors or disable bed exit functions.
Product
GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1887-2012·2012-07-04
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
X-COATED H/L PK W/FX15RW40 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-1864-2012·2012-07-04
Hill-Rom Recalls Advanta 2 Hospital Beds Due to Siderail Screw Stripping
Hill-Rom is recalling 7,843 Advanta 2 hospital beds because screws used to attach siderails were found to be stripping from the plastic cavity.
Product
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2012·2012-07-04
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
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) 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-1890-2012·2012-07-04
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 be dislodged.
Product
CPB CATHETER KIT- DR OWEN 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-1880-2012·2012-07-04
Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface of the tips can be dislodged during use.
Product
INDIANA/OHIO HEART 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-1867-2012·2012-07-04
Siemens BCS Behring Coagulation System Recalled for Potential Test Errors
Siemens Healthcare Diagnostics is recalling 186 BCS Behring Coagulation Systems because a specific sequence of tests may result in shortened clotting times.
Product
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1891-2012·2012-07-04
Terumo Recalls Sarns 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
CPB CATHETER KIT- DR HENDRICKSO 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-1861-2012·2012-07-04
Stryker Rose Bed Recall Due to Loadcell Failure in Scale Function
Stryker is recalling Rose Model FL14E beds because loadcell failures cause scale errors and disabled bed exit functions.
Product
Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface…
Category
Medical Device
Distribution
Distributed nationwide

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27651–27675 of 27722