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

35751–35775 of 40325

HighFDA (Devices)·Z-1577-2014·2014-05-21
Newport Medical e360 Ventilator Component Recalled for Audible Alarm Failure
Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.
Product
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1612-2014·2014-05-21
Medline Mucus Specimen Traps Recalled for Potential Sterility Issues
Medline Industries is recalling 1,610 mucus specimen traps because they may not be sterile, which could contaminate patient specimens.
Product
Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50).…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1573-2014·2014-05-21
SCC Soft Computer Recalls SoftMic Laboratory Information System Software
SCC Soft Computer is recalling SoftMic version 4.0.7.0 because missing SNOMED codes may cause incomplete patient data and delayed treatment updates.
Product
SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1616-2014·2014-05-21
Roche Recalls ACCU-CHEK Compact Plus Test Strips Due to Ceftriaxone Interference
Roche is recalling ACCU-CHEK Compact Plus test strips because they may produce erroneously low blood glucose readings in patients taking Ceftriaxone.
Product
ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1609-2014·2014-05-21
FDA Recalls Defective Ultrasound Needles That May Leak at Hub
RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.
Product
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1608-2014·2014-05-21
FDA Recalls Defective Ultrasound Needles That May Leak at Hub
RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.
Product
Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1606-2014·2014-05-21
Zimmer Recalls Neoprene Tennis Elbow Supports Due to Latex Contamination
Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports because raw material labeled as latex-free actually contained latex.
Product
Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2014·2014-05-21
Biomet ExploR Radial Stem Recalled for Missing Threads
Biomet is recalling eight ExploR 7x26mm Modular Radial Stem implants because missing wedge ramp threads may cause set screw loosening, potentially requiring revision surgery.
Product
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1605-2014·2014-05-21
Zimmer Hinged Knee Support Recalled Due to Latex Contamination
Zimmer, Inc. is recalling 546 units of Hinged Knee Supports because raw material labeled as latex-free actually contained latex.
Product
Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1604-2014·2014-05-21
Zimmer Cartilage Knee Brace Recalled Due to Latex Contamination
Zimmer, Inc. is recalling 2,222 units of Cartilage Knee Braces because raw material labeled as latex-free actually contained latex.
Product
Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1613-2014·2014-05-21
Siemens Syngo Dynamics PACS Recalled for Patient Demographics Display Error
Siemens Medical Solutions is recalling 50 Syngo Dynamics v9.5 systems due to a software error that may cause incorrect patient demographics to be displayed.
Product
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1575-2014·2014-05-21
Blue Belt Technologies Recalls Navio PFS Orthopedic Sterotaxic Instrument
Blue Belt Technologies is voluntarily recalling 11 Navio PFS systems used in orthopedic knee surgery due to a potential electronic module defect that could cause latent failure.
Product
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1607-2014·2014-05-21
HeartWare HVAD Pump Implant Kit Battery Recall for Support Issues
HeartWare Inc is recalling HVAD Pump Implant Kit batteries that may not provide two hours of support or behave unusually.
Product
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and…
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-1620-2014·2014-05-21
Baxter Recalls RAPIDFILL Syringe Strips Due to Sterile Barrier Breach
Baxter Corporation is recalling RAPIDFILL Syringe Strips because of a possible breach in the sterile barrier of the inner and outer bags.
Product
RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe…
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1618-2014·2014-05-21
Fresenius Hemodialysis Machines Recalled for Potential UF Pump Detection Failure
Fresenius Medical Care is recalling 79 hemodialysis machines and replacement parts because they may fail to detect a disconnected Ultrafiltration (UF) Pump.
Product
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1621-2014·2014-05-21
InterValve V8 Balloon Aortic Valvuloplasty Catheter Recalled for Leak Issues
InterValve Inc is recalling specific V8 Balloon Aortic Valvuloplasty Catheters due to leak issues discovered during accelerated age testing.
Product
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1603-2014·2014-05-21
Zimmer Drop Lok Knee Brace Recalled Due to Latex Contamination
Zimmer, Inc. is recalling Drop Lok Knee Braces because raw material labeled as latex-free was found to contain latex. The recall affects 131 units distributed in the US and internationally.
Product
DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1571-2014·2014-05-21
Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue
Codman & Shurtleff is recalling 90 MedStream Programmable Infusion Pumps because a small number may trigger a low battery alarm at the beginning of the implanted life.
Product
MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1610-2014·2014-05-21
Ortho Development Recalls PS-C Femoral Knee Implant Components
Ortho Development Corporation is recalling five PS-C Femoral Nonporous Rt Sz 6 knee implant components because pegged versions were found in boxes labeled for the pegless version.
Product
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1572-2014·2014-05-21
Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue
Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.
Product
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1576-2014·2014-05-21
FDA Recalls Unapproved Enaly 1000 BT-12 Ozone Generator for Medical Use
William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator because the device is not approved or cleared by the FDA for medical use.
Product
Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to…
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1611-2014·2014-05-21
Mindray DPM 6 Patient Monitor Recalled for Uncleared ST/Arrhythmia Feature
Mindray DS USA is recalling four DPM 6 patient monitors in Ohio because the included Multi Parameter Module contains a cardiac ST/Arrhythmia analysis feature that is not cleared for marketing.
Product
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1614-2014·2014-05-21
Greatbatch Recalls Coaxial Micro-Introducer Kits Due to Shelf Life Documentation Issues
Greatbatch Medical is recalling Coaxial Micro-Introducer Kits because documentation does not support the claimed five-year shelf life.
Product
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1574-2014·2014-05-21
Anspach Cutting Bur Recall Due to Incorrect Product Code Labeling
The Anspach Effort, Inc. is recalling 30 Anspach Cutting Burs (REF L-3SD) because the product code S-3SD was included, which is shorter than the labeled product.
Product
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1617-2014·2014-05-21
McKesson Radiology-PACS software recall for missing high-priority alert icon
McKesson Medical Imaging is recalling 45 units of McKesson Radiology-PACS software because the high-priority alert icon was not displayed when no Stat studies were present.
Product
McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

35751–35775 of 40325