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

35826–35850 of 40449

HighFDA (Devices)·Z-1646-2014·2014-05-28
Philips XIRIS 8.1.50.0 Recall Due to Patient Data Synchronization Error
Philips Healthcare Informatics is recalling 5 units of XIRIS 8.1.50.0 due to a synchronization error that may display incorrect patient information.
Product
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1635-2014·2014-05-28
Microline Renew Fenestrated Control Tip Grasper Recalled for Jaw Breakage
Microline Surgical is recalling 540 units of Renew Fenestrated Control Tip Graspers because the jaw may break when force is applied.
Product
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1650-2014·2014-05-28
Smiths Medical Recalls Snuggle Warm Sterile Cardiac Warming Blankets
Smiths Medical ASD, Inc. is recalling 2,120 Snuggle Warm Sterile Cardiac Connective Warming Blankets because the hose could separate from the blanket.
Product
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1627-2014·2014-05-28
Hospira Recalls Latex-Free 4-Lead T-U-R Irrigation Sets Due to Sealing Defect
Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.
Product
LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1647-2014·2014-05-28
Siemens Recalls Dimension Vista Cyclosporine Test Kits Due to Under-Recovery
Siemens Healthcare Diagnostics is recalling Dimension Vista CSA and CSAE test kits because they may under-recover cyclosporine levels when using Small Sample Containers.
Product
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1651-2014·2014-05-28
Heraeus Kulzer Recalls Gluma Desensitizer Power Gel Due to Extrusion Risk
Heraeus Kulzer is recalling Gluma Desensitizer Power Gel because it may extrude all at once, causing irritation, burning, or blistering to patients or dental professionals.
Product
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1649-2014·2014-05-28
Medline Esmark Elastic Bandages Recalled for Sterilization Failure
Medline Industries is recalling 2,860 Esmark Elastic Bandages because they may not have been properly sterilized.
Product
Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1630-2014·2014-05-28
SCM True Air Technologies Recalls JK Bariatric Beds for Design Control Failures
SCM True Air Technologies is recalling 24 JK Bariatric Beds nationwide due to lack of design controls, missing Device Master Records, and unapproved vendors.
Product
JK Bariatric Beds, True Air Technologies, Inc.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1642-2014·2014-05-28
Fujifilm Recalls 14 MXR-35 X-ray Generators for Missing Certification Labeling
Fujifilm Medical System USA is recalling 14 MXR-35 Diagnostic X-ray High Voltage Generators because the labeling did not include the certification statement required by 21 CFR Part 10 10.2.
Product
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1648-2014·2014-05-28
Ortho-Clinical VITROS TT4 Calibrator Recalled for Calibration Failures
Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators due to potential calibration failures or low quality control results.
Product
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1625-2014·2014-05-28
Hospira Recalls Cystoscopy Sets Due to Potential Sterile Package Seal Defect
Hospira Inc. is recalling specific cystoscopy and irrigation sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1633-2014·2014-05-28
Arrowgard Blue Central Venous Catheter Recalled for Labeling Error
Arrow International Inc. is recalling Arrowgard Blue and Blue Plus catheters because the packaging incorrectly lists an echogenic needle, which may not be present.
Product
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1632-2014·2014-05-28
SCM True Air Technologies Recalls MaXair Mattress Replacement Systems
SCM True Air Technologies is recalling 83 MaXair True Low Air Loss Mattress Replacement Systems due to design control and documentation deficiencies.
Product
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1623-2014·2014-05-28
Hospira Recalls Latex-Free Extension Sets Due to Packaging Seal Defect
Hospira is recalling specific latex-free extension sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1622-2014·2014-05-28
Siemens syngo Imaging XS Software Recall Due to Data Deletion Risk
Siemens Medical Solutions is recalling 64 syngo Imaging XS systems because a software change may have caused the deletion of archived medical images.
Product
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1629-2014·2014-05-28
Anspach Irrigation Clip 40 Recalled Due to Incorrect Assembly
The Anspach Effort, Inc. is recalling 150 Anspach Irrigation Clip 40 units because they were assembled with incorrect, smaller clips.
Product
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1631-2014·2014-05-28
SCM True Air Technologies Recalls ECATS E 850 Bariatric Beds
SCM True Air Technologies is recalling 48 ECATS E 850 Bariatric Beds due to manufacturing documentation and vendor approval failures.
Product
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1566-2014·2014-05-21
Baxter ABACUS TPN Calculation Software Recalled for Calculation Errors
Baxter Corporation is recalling ABACUS TPN Calculation Software because it may calculate incorrect electrolyte quantities and display inaccurate data.
Product
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1619-2014·2014-05-21
Fresenius Hemodialysis Machine Test Boards Recalled for Pump Detection Failure
Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.
Product
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1567-2014·2014-05-21
CareFusion Recalls Alaris Pump 8100 Due to Software Delay Issue
CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.
Product
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids…
Category
Medical Device
Distribution
Distributed nationwide
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

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35826–35850 of 40449