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 deaths or serious injuries are reported, 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

4751–4775 of 5038

SevereFDA (Devices)·Z-1698-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 30 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1699-2013·2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1693-2013·2013-07-17
Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material
Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.
Product
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1669-2013·2013-07-17
Cardio Medical Products Defibrillator Electrodes Recalled for Arcing and Sparking
Cardio Medical Products is recalling 657 defibrillator electrodes due to reports of arcing and sparking on the leadwire.
Product
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1685-2013·2013-07-17
Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage
Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.
Product
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1648-2013·2013-07-10
Ortho-Clinical VITROS 4600 Chemistry System Recalled for Electrical Short
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because an electrical short in the connector caused heat accumulation and melted wiring.
Product
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, io
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1663-2013·2013-07-10
Siemens Linear Accelerator Recall Due to Potential Patient Mistreatment
Siemens is recalling specific linear accelerator systems because a difficult-to-interpret calibration issue may have resulted in the mistreatment of cancer patients.
Product
Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1620-2013·2013-07-10
Zimmer Recalls Fukuda Retractors Due to Fractures During Surgery
Zimmer, Inc. is recalling Fukuda retractors because they fracture at the grooves during use. The recall includes 722 units distributed worldwide.
Product
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1651-2013·2013-07-10
Ortho Assay Software Server Recalled Due to Electrical Short and Heat
Ortho-Clinical Diagnostics is recalling 31 units of the ORTHO Assay Software Server because an electrical short caused heat accumulation and melted wiring.
Product
ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1650-2013·2013-07-10
Ortho-Clinical VITROS 3600 Immunodiagnostic System Recalled for Electrical Short
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic Systems because an electrical short caused heat accumulation that melted wiring and connectors.
Product
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1656-2013·2013-07-10
HealthLink Recalls Biopsy Punches Due to Lack of Sterilization
Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.
Product
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1661-2013·2013-07-10
DJO VenaFlow Elite Compression Pump Recalled for Battery Fire Risk
DJO, LLC is recalling VenaFlow Elite 30B-B and 30BI-B compression pumps due to a potential battery leakage issue that could cause a fire.
Product
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1647-2013·2013-07-10
Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems Due to Electrical Short
Ortho-Clinical Diagnostics is recalling 101 VITROS 5,1 FS Chemistry Systems because an electrical short can cause heat accumulation and melted wiring.
Product
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1621-2013·2013-07-10
Zimmer Recalls Fukuda Retractors Due to Fracture Risk During Surgery
Zimmer, Inc. is recalling Fukuda-type retractors because they may fracture at the grooves during surgical use. This recall expands a 2010 action to include seven additional lots.
Product
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1649-2013·2013-07-10
Ortho-Clinical VITROS 5600 Integrated System Recalled for Electrical Short
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to an electrical short that caused heat accumulation and melted wiring.
Product
VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1570-2013·2013-07-03
Medtronic SynchroMed II Pump Recall for Unintended Drug Delivery
Medtronic is recalling SynchroMed II implantable infusion pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose symptoms.
Product
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanta
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1586-2013·2013-07-03
Medrad Recalls DC Power Cables for Veris MR Vital Signs Monitor
Medrad Inc is recalling 1,066 DC power cables for the Veris MR Vital Signs Monitor due to a design issue that could cause shorting and heating.
Product
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1548-2013·2013-06-26
Biomet Recalls Superior Approach Resection Guide Assembly Due to Slot Offset
Biomet is recalling 17 units of the Superior Approach Resection Guide Assembly because a manufacturing defect may prevent the guide from securing properly to bone during surgery.
Product
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1537-2013·2013-06-26
Respironics V60 Ventilator Recalled for Power Management Board Software Issue
Respironics is recalling V60 ventilators due to a software issue on the Power Management Board Assembly that could cause loss of ventilator support without an audible alarm.
Product
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1456-2013·2013-06-12
Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
Symbios Medical Products is voluntarily recalling GoPump kits because some units may deliver excessively high flow rates.
Product
Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapi
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1462-2013·2013-06-12
Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 because they may deliver excessively high flow rates.
Product
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self conta
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1452-2013·2013-06-12
Symbios Recalls GoPump Infusion Pumps Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.
Product
Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 51004
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1466-2013·2013-06-12
Hill-Rom 1000 Hospital Bed Recalled Due to Brake Disengagement Risk
Hill-Rom, Inc. is recalling 8,737 Hill-Rom 1000 Beds because brakes may disengage when the bed frame is subjected to a hard jolt or force.
Product
Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1467-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
The FDA is recalling 2,716 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1442-2013·2013-06-12
Intuitive Surgical Recalls Monopolar Curved Scissors Due to Thermal Injury Risk
Intuitive Surgical is recalling approximately 132,441 EndoWrist Monopolar Curved Scissors instruments worldwide. The recall addresses potential cracks that may cause electrosurgical energy leaks and thermal injury to tissue.
Product
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in co
Category
Medical Device
Distribution
Distributed nationwide

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