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

36851–36875 of 40449

ModerateFDA (Devices)·Z-0615-2014·2014-01-08
Synthes Electric Pen Drive Hand Switch Recalled for Labeling Error
Synthes USA HQ, Inc. is recalling 290 Electric Pen Drive Hand Switches because the 'on' and 'lock' labels were interchanged.
Product
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0606-2014·2014-01-08
RTC 25-C Inline Aerosol Tee Adapter Recalled for Incomplete Instructions
Instrumentation Industries Inc. is recalling 220 units of the RTC 25-C Inline Aerosol Tee Adapter because some packages were shipped with incomplete installation and usage directions due to a printing error.
Product
RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0619-2014·2014-01-08
AdvanDx Gram-Negative QuickFISH BC Kits Recalled for Microscope Incompatibility
AdvanDx is recalling Gram-Negative QuickFISH BC kits because they are incompatible with certain fluorescence microscope light sources.
Product
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae…
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-0614-2014·2014-01-08
Merit Medical Systems Recalls Maestro Microcatheters Due to Label Graphic Discrepancy
Merit Medical Systems is recalling 59 Maestro Microcatheters because the graphic on the carton's end panel does not match the front panel.
Product
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0534-2014·2014-01-01
CareFusion Recalls Alaris PC Units Due to System Error Messages
CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.
Product
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0531-2014·2014-01-01
C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies
C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.
Product
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2014·2014-01-01
B. Braun IV Catheters Recalled for Missing Safety Clip
B. Braun Medical is recalling 55,200 Introcan Safety IV Catheters because one lot may lack the anti-needlestick safety clip.
Product
B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0552-2014·2014-01-01
Varian Eclipse Treatment Planning System Software Deficiency Recall
Varian Medical Systems is recalling Eclipse Treatment Planning System software due to a defect that may cause Monitor units to change unexpectedly during dose parameter adjustments.
Product
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0556-2014·2014-01-01
McKesson Radiology 12.0 PACS Recall for Missing Contrast Allergy Data
McKesson Information Solutions LLC is recalling McKesson Radiology 12.0 PACS because merging patient records may result in missing contrast allergy information.
Product
McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0581-2014·2014-01-01
Smith & Nephew Recalls Reflection Acetabular Liners Due to Tolerance Issues
Smith & Nephew is recalling 38 units of Reflection acetabular liners because they may be out of tolerance and fail to fully seat into the shell.
Product
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0578-2014·2014-01-01
Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.
Product
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0580-2014·2014-01-01
EOS Imaging Recalls steroEOS Workstation Due to Data Copying Error
EOS Imaging is recalling 36 steroEOS Workstation units because a software error may prevent 3D model data from copying to clinical files and reports.
Product
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0570-2014·2014-01-01
Philips HeartStart MRx Defibrillator Recall for EtCO2 Display Error
Philips is recalling HeartStart MRx defibrillators because they display a question mark instead of a value when patient CO2 levels fall below 7.6 mmHg.
Product
Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2014·2014-01-01
Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.
Product
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0572-2014·2014-01-01
Trinity Biotech Recalls Captia Syphilis-G Test Kits Due to False Negatives
Trinity Biotech is recalling Captia Syphilis-G Test Kits because they may produce false negative results for syphilis antibodies.
Product
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum (…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2014·2014-01-01
Stryker Orthopaedics Ball Impactor Tip Recalled for Cracks and Fractures
Stryker Howmedica Osteonics Corp. is recalling Ball Impactor Tips used in surgery due to complaints of cracks and fractures.
Product
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0582-2014·2014-01-01
Stryker Orthopaedics Recalls Rim Impactor Tips Due to Cracks and Fractures
Stryker Howmedica Osteonics Corp. is recalling 1,690 Rim Impactor Tips used in MDM surgery due to complaints of cracks and fractures.
Product
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0561-2014·2014-01-01
Siemens Dimension Chemistry Wash Recalled for Result Shifts
Siemens is recalling Dimension Chemistry Wash lots that may cause shifts in QC and patient sample results for specific tests.
Product
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0567-2014·2014-01-01
Ziehm Vision R C-Arm X-Ray System Recalled for Emergency Switch Issue
Ziehm Imaging Inc is recalling 103 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component.
Product
Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0493-2014·2014-01-01
Biomet Recalls G7 Acetabular Screws Due to Incorrect Diameter Labeling
Biomet is recalling G7 Acetabular Screws because the labels incorrectly list the diameter as 10.5mm instead of the actual 6.5mm.
Product
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0551-2014·2014-01-01
Integra Recalls Cranial Access Kits Due to Labeling Discrepancies
Integra LifeSciences is voluntarily recalling unexpired lots of HITHSP10 Cranial Access Kits because the labeling for included DuraPrep and Monocryl sutures does not align with the kit's intended use.
Product
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0558-2014·2014-01-01
Abbott Recalls HT Connect Peripheral Guide Wires Due to Coating Delamination
Abbott Vascular is recalling HT Connect Peripheral Guide Wires because a small number of devices show partial delamination of the PTFE coating.
Product
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0576-2014·2014-01-01
SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. The recall covers nationwide distribution.
Product
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0568-2014·2014-01-01
Ziehm Vision RFD C-Arm X-Ray System Recalled for Emergency Switch Change
Ziehm Imaging Inc is recalling 27 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Product
Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0565-2014·2014-01-01
Ziehm Vision C-Arm X-Ray System Recalled for Emergency Switch Change
Ziehm Imaging Inc is recalling 54 Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Product
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
Distributed nationwide

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36851–36875 of 40449