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

24301–24325 of 27699

SevereFDA (Devices)·Z-0156-2015·2014-11-12
Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect
Terumo is recalling specific Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.
Product
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0125-2015·2014-11-12
TriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue
TriVascular is recalling specific lots of Ovation Prime Abdominal Stent Grafts because the fill polymer syringe may empty rapidly during the implant procedure.
Product
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0084-2015·2014-11-12
Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path
Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.
Product
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0085-2015·2014-11-12
Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path
Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.
Product
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0168-2015·2014-11-12
IBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors
Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.
Product
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0159-2015·2014-11-12
Terumo Cardiovascular Procedure Kits Recalled for Luer Connector Defect
Terumo is recalling specific cardiovascular and perfusion procedure kits because a luer connector defect may compromise the seal and introduce air into the table line.
Product
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2015·2014-11-12
Cynosure Elite XPL Handpiece Recalled for Electrical Shock Risk
Cynosure, Inc. is recalling 322 Elite XPL handpieces for the Elite MPX Laser System due to a potential risk of electrical shock when the device is adjusted or removed while powered on.
Product
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2015·2014-11-12
Dokitz NovoSci Recalls Cardiopulmonary Bypass Connectors Due to Detachment Risk
Dokitz NovoSci is recalling 240 units of cardiopulmonary bypass connectors because the single leg of the PAY connector has been observed to become detached.
Product
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0157-2015·2014-11-12
Terumo Cardioplegia Delivery Set Line Recalled for Luer Connector Defect
Terumo is recalling 165 units of a cardioplegia delivery set line because a luer connector defect can compromise the seal and introduce air into the line.
Product
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2015·2014-11-12
Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect
Terumo is recalling 777 Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.
Product
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2015·2014-11-12
Terumo Custom Cardioplegia Delivery Set Recalled for Luer Connector Defect
Terumo is recalling Custom Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.
Product
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0161-2015·2014-11-12
Terumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect
Terumo is recalling 24 units of Custom Cardioplegia Delivery Sets because a luer connector defect may compromise the seal and introduce air into the line.
Product
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0165-2015·2014-11-12
Zimmer Surgical Recalls Universal Modular Electric Handpieces Due to Malfunction
Zimmer Surgical Inc is recalling 828 Universal Modular Electric/Battery Handpieces because a malfunction allows them to start unexpectedly when connected to a power source.
Product
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2015·2014-11-12
Stryker SmartLife Aseptic Housings Recalled for Welding Defect
Stryker is recalling SmartLife Large Aseptic Housings because the top section may separate from the bottom due to insufficient welding.
Product
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0163-2015·2014-11-12
C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets
C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.
Product
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle…
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0173-2015·2014-11-12
Stryker SmartLife Aseptic Housings Recalled for Welding Defect
Stryker is recalling SmartLife Small Aseptic Housings because the top section may separate from the bottom due to insufficient welding.
Product
Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0096-2015·2014-11-05
Hospira Recalls GemStar Power Supply Due to Power Delivery Failure
Hospira is recalling GemStar Power Supplies because they may fail to provide direct current power to the infusion pump, potentially causing smoke.
Product
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
Category
Medical Device
Distribution
49 states
SevereFDA (Devices)·Z-0095-2015·2014-11-05
Hospira Recalls GemStar Power Supplies Due to Power Delivery Failure
Hospira is recalling 978 GemStar Power Supplies because they may fail to provide power to the infusion pump, resulting in smoke.
Product
The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
Category
Medical Device
Distribution
49 states
SevereFDA (Devices)·Z-0142-2015·2014-11-05
Mabis Recalls DMI Rollator Transport Chairs Due to Collapse Risk
Briggs Medical Service Company is recalling 1,869 DMI Rollator Transport Chairs because they may collapse during use.
Product
DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0112-2015·2014-11-05
FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue
The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.
Product
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0151-2015·2014-11-05
Joerns EasyCare Bed Recalled Due to Care-Lock Feature Failure Risk
Joerns Healthcare is recalling 3,135 EasyCare Beds because the Care-Lock feature may fail to stay engaged, posing a safety risk to patients.
Product
Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0130-2015·2014-11-05
Siemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Realignment Issue
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue with Ferritin Analytical Sensitivity. The recall affects 234 kits distributed worldwide.
Product
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2015·2014-11-05
Merge Hemo Diagnostic Computer Recalled for Stale Oxygen and Heart Rate Data
Merge Healthcare is recalling 52 Hemo Programmable diagnostic computers because the SpO2 and heart rate values displayed may not update to reflect changes in the patient's condition.
Product
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0146-2015·2014-11-05
Roche Recalls ACCU-CHEK Spirit Combo Insulin Pumps Due to Time Settings
Roche is recalling 8,116 ACCU-CHEK Spirit Combo insulin pumps because a faulty capacitor may cause time and date settings to reset, potentially shifting insulin delivery schedules.
Product
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2015·2014-11-05
Siemens Phenytoin Reagent Cartridge Recalled for Potential Test Bias
Siemens Healthcare Diagnostics is recalling 1,733 Phenytoin Flex Reagent Cartridges due to internal testing that confirmed a low absorbance range, which may result in biased or imprecise test results.
Product
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results…
Category
Medical Device
Distribution
Distributed nationwide

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