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

40401–40425 of 40480

ModerateFDA (Devices)·Z-1903-2012·2012-07-04
Polymer Technology Systems Recalls PTS Panels Creatinine Test Strips
Polymer Technology Systems is recalling 1,650 vials of PTS Panels Creatinine Test Strips because they may provide inaccurate results outside the reportable range.
Product
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1860-2012·2012-07-04
Stryker Recalls Go Bed II+ Units Due to Scale and Bed Exit Failures
Stryker is recalling 8,009 Go Bed II+ Model FL28C hospital beds worldwide due to a high failure rate of loadcells that affects scale and bed exit functions.
Product
Go Bed II+ Model FL28C 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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1844-2012·2012-06-27
FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of Covidien ROTICULATOR 55-3.5 Single Use Staplers because the sterility barrier may be compromised, posing a risk of infection during surgery.
Product
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1823-2012·2012-06-27
Arrow Recalls Central Venous Catheters Due to Potential Hub Voids
Arrow International is recalling 1,085 units of 7FR 3-Lumen Arrowg+ard Blue Plus Central Venous Catheters due to potential voids in the catheter hub that could cause interlumen crossover.
Product
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1774-2012·2012-06-27
Nidek Medical Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 7,889 oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Product
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1787-2012·2012-06-27
GE Healthcare Recalls Aestiva 7900 Anesthesia Machines Due to Missing Interlock
GE Healthcare is recalling eight Aestiva 7900 anesthesia machines because a missing interlock slide may allow two vaporizers to deliver agents simultaneously.
Product
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1846-2012·2012-06-27
FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of Covidien ROTICULATOR 30-3.5 Single Use Staplers because the sterility barrier may be compromised, potentially affecting surgical safety.
Product
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1778-2012·2012-06-27
Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 730 NUVO LITE oxygen concentrators because a capacitor failure could cause a fire or loss of oxygen.
Product
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1780-2012·2012-06-27
Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 14,585 NUVO LITE oxygen concentrators worldwide because a capacitor failure could cause a fire or loss of supplemental oxygen.
Product
NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1779-2012·2012-06-27
Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 3,638 NUVO LITE oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Product
NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1845-2012·2012-06-27
FDA Recalls Covidien Roticalator Staplers Due to Sterility Barrier Risk
The FDA is recalling 13,531 units of the Covidien ROTICULATOR 55-4.8 Single Use Stapler because the sterility barrier may be compromised.
Product
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1782-2012·2012-06-27
Nidek Medical Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling MARK5 NUVO oxygen concentrators because a capacitor failure could cause a fire and stop oxygen supply.
Product
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1777-2012·2012-06-27
Nidek Medical Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 335 MARK5 NUVO 8 oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Product
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1781-2012·2012-06-27
Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling NUVO LITE oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Product
NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1775-2012·2012-06-27
Nidek Medical Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling M5C5/Mark5 Nuvo/OCSI oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Product
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1776-2012·2012-06-27
Nidek Medical Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 82 MARK5 NUVO 8 STD oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.
Product
NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1837-2012·2012-06-27
Terumo Recalls Sarns Flexible Arterial Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connector surface can be dislodged during use.
Product
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1849-2012·2012-06-27
Medtronic 0-arm Imaging System Recalled for Navigational Accuracy Issues
Medtronic is recalling three 0-arm Imaging Systems because software version 3.1.1 does not meet navigational accuracy standards.
Product
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1833-2012·2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that can be dislodged.
Product
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1855-2012·2012-06-27
Genzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect
Genzyme is recalling Seprafilm Procedure Packs because a packaging defect may compromise the product's sterility. The recall affects units distributed in the US and South Korea.
Product
seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1838-2012·2012-06-27
Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that could dislodge during use.
Product
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1839-2012·2012-06-27
Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance
Terumo is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.
Product
24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2012·2012-06-27
FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of the Covidien ROTICULATOR 30-4.8 Single Use Stapler because the sterility barrier may be compromised.
Product
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1835-2012·2012-06-27
Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connectors can be dislodged during use.
Product
SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1843-2012·2012-06-27
Natus Olympic Cool-Cap System Recalled Due to Power Supply Failure
Natus Medical is recalling 181 Olympic Cool-Cap Systems because the power supply may fail without warning, interrupting cooling treatment for infants.
Product
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides…
Category
Medical Device
Distribution
Distributed nationwide

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40401–40425 of 40480