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

35301–35325 of 40325

HighFDA (Devices)·Z-2076-2014·2014-07-23
Pioneer Surgical Technology Recalls Tritium Sternal Plate System Due to Sterility Concerns
Pioneer Surgical Technology is recalling 5 units of the Tritium Sternal Plate System in Texas and Florida due to a lack of sterility assurance.
Product
Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2051-2014·2014-07-23
Shape HF Cardiopulmonary System Recalled for Software Upgrade Requirement
Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.
Product
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2047-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach
Smith & Nephew is recalling 907 units of SUTUREFIX Ultra S devices because a breach in the sterile barrier compromises the device's sterility.
Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2062-2014·2014-07-23
Instrumentation Laboratory Recalls ACL TOP CTS Coagulation Instruments
Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Product
ACL TOP CTS, automated coagulation laboratory instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2070-2014·2014-07-23
Excelsior Medical Recalls Sterile Triple Lead Tubing Sets Due to Leak Risk
Excelsior Medical is recalling sterile triple lead tubing sets because a molding defect may allow fluid leaks or air entry during use.
Product
Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2029-2014·2014-07-23
Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks
Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.
Product
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2064-2014·2014-07-23
Instrumentation Laboratory Recalls ACL TOP 500 CTS Coagulation Instruments
Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Product
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2045-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.
Product
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2028-2014·2014-07-23
Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks
Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.
Product
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2048-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach
Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.
Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2055-2014·2014-07-23
Stryker Communications Recalls SHAPE Arm Brackets for Boom Systems
Stryker Communications is recalling 953 SHAPE Arm brackets used in operating rooms because the monitor mount may detach if specific hardware is missing.
Product
BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2053-2014·2014-07-23
Stryker SHAPE Arm Dual SH2 Recalled for Potential Monitor Detachment
Stryker Communications is recalling SHAPE Arm Dual SH2 brackets because the monitor mount may detach if specific hardware is missing.
Product
SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2014·2014-07-23
Stryker Communications Recalls SHAPE Arm Brackets for Potential Monitor Detachment
Stryker Communications is recalling 953 SHAPE Arm brackets because the monitor mount may detach if a lock washer and screw are missing.
Product
BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2061-2014·2014-07-23
Instrumentation Laboratory Recalls ACL TOP 700 Coagulation Instruments
Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.
Product
ACL TOP 700, automated coagulation laboratory instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2063-2014·2014-07-23
Instrumentation Laboratory Recalls ACL TOP 700 LAS Coagulation Instruments
Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.
Product
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2014·2014-07-23
Mindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors
Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.
Product
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2049-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach
Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.
Product
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2065-2014·2014-07-23
Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments
Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Product
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2069-2014·2014-07-23
Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval
Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.
Product
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2043-2014·2014-07-23
Siemens Symbia E Camera System Recalled for Loose Rear Casters
Siemens Medical Solutions USA is recalling 531 Symbia E camera systems because the collimator cart rear casters may become loose.
Product
Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2014·2014-07-23
Dental EZ Group Recalls 45 Mislabelled Titan T 5K Dental Motors
Dental EZ Group is recalling 45 Titan T 5K dental motors because the housing was incorrectly laser marked as a 20K motor.
Product
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2077-2014·2014-07-23
Spacelabs Ultraview SL Multigas Module Recalled for Invalid MAC Display
Spacelabs Healthcare is recalling 8 Ultraview SL Multigas Modules because the software displays an invalid Minimum Alveolar Concentration value.
Product
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2057-2014·2014-07-23
Remel Inc. Recalls Thermo Scientific VersaTREK REDOX 1 In Vitro Diagnostic Product
Remel Inc. is recalling specific lots of Thermo Scientific VersaTREK REDOX 1 in vitro diagnostic products because they failed to provide positive signals for Streptococcus pneumoniae.
Product
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2073-2014·2014-07-23
Laser Peripherals Recalls Mislabelled Bare Laser Fibers Due to Date Error
Laser Peripherals LLC is recalling 25 units of DBLF-60-2 Bare Laser Fibers because a sterility expiration date was misprinted as '2016-16' instead of '2016-06'.
Product
LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2050-2014·2014-07-23
Zimmer Dental Tapered Screw-Vent Implant Recalled for Potential Vial Crack
Zimmer, Inc. is voluntarily recalling a specific lot of dental implants due to a potential crack in the outer vial cap.
Product
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Category
Medical Device
Distribution
Distributed nationwide

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