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

31901–31925 of 40449

HighFDA (Devices)·Z-2812-2015·2015-09-30
Siemens Medical Solutions Recalls Linear Accelerator Systems Due to Collision Risk
Siemens Medical Solutions is recalling 26 linear accelerator systems and associated software because a defect could cause automatic movement, posing a collision risk to patients.
Product
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2795-2015·2015-09-30
Brainlab Disposable Reflective Marker Spheres Recalled for Separation Risk
Brainlab AG is recalling Disposable Reflective Marker Spheres because they may separate at the mid-point seal, posing a risk to patients during image-guided surgery.
Product
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2816-2015·2015-09-30
Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias
Siemens is recalling 49 RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.
Product
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2787-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
Terumo is recalling 32 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2797-2015·2015-09-30
Bien Air Dental Contra-Angles Recalled for Potential Tool Loosening
Bien Air Dental SA is recalling specific EVO 15 contra-angles because the dental tool may loosen and be swallowed.
Product
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2789-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators
Terumo is recalling six custom cardiovascular procedure kits nationwide because they contain recalled Medivators HPH700 hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2786-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators
Terumo is recalling 5 Custom Cardiovascular Procedure Kits because they contain recalled Medivators HPH700 Hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2792-2015·2015-09-30
Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect
Terumo is recalling 17 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.
Product
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2780-2015·2015-09-30
Edwards Lifesciences Recalls ThruPort Knot Pusher Due to Suture Fraying Risk
Edwards Lifesciences is recalling 759 ThruPort Knot Pusher units because the device's tip design may cause suture fraying or splitting, potentially compromising suture knot integrity during cardiac surgery.
Product
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2793-2015·2015-09-30
Ecolab Recalls Microtek ORS Fluid Warming and Slush Drapes Due to Seal Defects
Ecolab is recalling Microtek ORS Fluid Warming and Slush Drapes because sterile packaging seals may contain small channels, potentially compromising package integrity and sterility.
Product
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2811-2015·2015-09-30
Synthes Cranial Flap Tube Clamp Recalled for Incorrect MR Safe Labeling
Synthes (USA) Products LLC is recalling Cranial Flap Tube Clamps and Crimping Devices because they were labeled MR Safe without required testing protocols.
Product
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2807-2015·2015-09-30
Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures
Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection procedures.
Product
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2796-2015·2015-09-30
OrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error
OrthoPediatrics Corp is recalling 3.5mm Non Locking Cortical Screws because the packaging may contain a different screw size than labeled.
Product
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2805-2015·2015-09-30
Fujifilm EPX 2500 Operation Manual Recalled for Incorrect Endoscope Specifications
Fujifilm is recalling 60 EPX 2500 Operation Manuals and sales brochures that incorrectly identify the ED-530XT endoscope's image capabilities.
Product
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2804-2015·2015-09-30
Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling
Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.
Product
The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-2808-2015·2015-09-30
Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures
Bard Access Systems is recalling 1,811 marketing brochures for PowerPICC and PowerPICC SOLO catheters because they contain incorrect indications for use.
Product
Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2800-2015·2015-09-30
Zien Medical PenBlade Safety Scalpel Recalled for Sterile Barrier Risk
Zien Medical Technologies is recalling PenBlade Safety Scalpels because cracks in the PET trays may compromise the sterile barrier.
Product
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2815-2015·2015-09-30
Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias
Siemens is recalling 982 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.
Product
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2806-2015·2015-09-30
Fujifilm EPX 2500 Processor Manual and Brochure Recall
Fujifilm is recalling EPX 2500 Processor manuals and brochures that incorrectly identify the ED-530XT endoscope's image quality.
Product
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2817-2015·2015-09-30
BD Biosciences Recalls CD4 FITC Reagent Due to Spanish Labeling Error
Becton, Dickinson and Company is recalling 128 units of CD4 (SK3), FITC reagent because the Spanish text on the label incorrectly identifies the product as CD8 FITC.
Product
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2810-2015·2015-09-30
Stryker Recalls Trident Hip Implant Components Due to Documentation Error
Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.
Product
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-2731-2015·2015-09-23
SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure
SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.
Product
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2770-2015·2015-09-23
Lumenis VersaCut+ Tissue Morcellator Hand Pieces Recalled for Unpredictable Operation
Lumenis is recalling VersaCut+ Tissue Morcellator hand pieces because they may operate unpredictably during surgery, potentially damaging non-target tissue.
Product
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2769-2015·2015-09-23
Applied Medical Resources Recalls Voyant Open Fusion Devices
Applied Medical Resources Corp is recalling Voyant Open Fusion Devices due to a potential risk of improper tissue characterization, which may result in nonoptimal power delivery.
Product
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2762-2015·2015-09-23
Revmedx Recalls XGAUZE Trauma Dressings Due to Potential Package Integrity Issues
Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.
Product
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids.…
Category
Medical Device
Distribution
5 states

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31901–31925 of 40449