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

27926–27950 of 40357

ModerateFDA (Devices)·Z-1001-2017·2017-01-18
Siemens Biograph mCT Flow Edge-4R Scanner Recall for Laser Cover Windows
Siemens Medical Solutions is recalling one Biograph mCT Flow Edge-4R scanner because laser cover windows may fall off.
Product
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0999-2017·2017-01-18
Siemens Biograph mCT-X Scanner Recall Due to Falling Laser Cover Windows
Siemens Medical Solutions is recalling Biograph mCT-X scanners because laser cover windows may fall off.
Product
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0959-2017·2017-01-18
Brainlab Knee Navigation Cutting Block Adapter Base Recalled for Material Error
Brainlab AG is recalling specific femoral and tibial cutting block adapter bases because they may contain incorrect material, making them unsuitable for reprocessing.
Product
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0961-2017·2017-01-18
Implant Direct Recalls GoDirect Screw-Retaining Top Due to Labeling Error
Implant Direct Sybron Manufacturing is recalling 14 units of GoDirect Screw-Retaining Top (Part No. 4500-61) because they were shipped with incorrect labels for a different product.
Product
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0995-2017·2017-01-18
Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows
Siemens Medical Solutions is recalling 88 Biograph mCT scanners because laser cover windows may fall off.
Product
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0958-2017·2017-01-18
Straumann Twist Drill PRO Recalled for Tolerance Specification Defects
Straumann Manufacturing is recalling 120 units of Twist Drill PRO dental implant accessories because they cannot be inserted into handpieces due to tolerance specification failures.
Product
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0960-2017·2017-01-18
Trilliant Tiger Screw Sterilization Tray Base Assembly Recall for Printing Error
Trilliant Surgical Ltd. is recalling Tiger Screw Sterilization Tray Base Assemblies due to a printing error on k-wire description markings.
Product
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0993-2017·2017-01-18
Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows
Siemens is recalling 34 Biograph mCT scanners because laser cover windows may fall off, posing a potential hazard to users.
Product
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0981-2017·2017-01-18
Bard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
Bard Access Systems is recalling StatLock PICC Plus Crescent Foam devices because some pouches lack unique product identifiers like lot numbers.
Product
StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0974-2017·2017-01-18
GE OEC MiniView 6800 C-Arm Recalled for Power Cable Failures
GE Healthcare is conducting a voluntary field action for OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 devices due to intermittent power cord failures.
Product
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for…
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0982-2017·2017-01-18
Bard Access Systems Recalls StatLock Catheter Stabilization Devices
Bard Access Systems is voluntarily recalling StatLock CV Plus catheter stabilization devices because some pouches lack unique product identifiers.
Product
StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0971-2017·2017-01-18
Siemens Artis zee/zeego Angiographic X-ray System Recall for Generator Defects
Siemens is recalling Artis zee/zeego angiographic x-ray systems due to potential high-voltage generator failures and rare image display loss.
Product
Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0985-2017·2017-01-18
Bard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors
Bard Access Systems is recalling MiniLoc Safety Infusion Sets because some units have needle lengths and gauges that differ from the label descriptions.
Product
MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1016-2017·2017-01-18
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
Hospira is voluntarily recalling one lot of Minibore Extension Sets due to a confirmed report of solvent occlusion that may prevent priming and delay therapy.
Product
Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0998-2017·2017-01-18
Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall
Siemens Medical Solutions is recalling Biograph mCT PET/CT scanners because laser cover windows may fall off.
Product
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0980-2017·2017-01-18
ICU Medical Recalls 24-Hour Primary Sets with Incorrect Drip Chambers
ICU Medical is recalling 225 units of 24-hour primary sets where a 15-drop drip chamber was installed instead of the required 60-drop chamber.
Product
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0973-2017·2017-01-18
GE Healthcare Recalls OEC 9800 Imaging Systems Due to Power Cable Failures
GE Healthcare is conducting a voluntary field action for OEC 9800 systems because the workstation power cable assembly can cause intermittent power cord failures.
Product
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic…
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0986-2017·2017-01-18
Bard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors
Bard Access Systems is recalling SafeStep Huber Needle Sets because some units may have needle lengths or gauges that differ from the label.
Product
SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0996-2017·2017-01-18
Siemens Biograph mCT PET/CT Scanners Recalled for Falling Laser Cover Windows
Siemens Medical Solutions is recalling 102 Biograph mCT PET/CT scanners because laser cover windows may fall off.
Product
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1000-2017·2017-01-18
Siemens Biograph mCT 20 Excel PET/CT Scanner Recall for Laser Cover Windows
Siemens is recalling 51 Biograph mCT 20 Excel scanners because laser cover windows may fall off.
Product
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0955-2017·2017-01-18
VOCO Futurabond M+ adhesive recalled for labeling mix-up
Voco GmbH is recalling 50 units of VOCO Futurabond M+ adhesive due to a labeling error where the product was marked as Futurabond M+ Universal Adhesive.
Product
VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0994-2017·2017-01-18
Siemens Biograph mCT X-4R Laser Cover Window Recall
Siemens is recalling 71 Biograph mCT X-4R scanners because laser cover windows may fall off.
Product
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0983-2017·2017-01-18
Bausch & Lomb Recalls Algerbrush-II Ophthalmic Surgical Instruments
Bausch & Lomb is recalling Algerbrush-II surgical instruments because some units shipped with outdated operating instructions.
Product
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0992-2017·2017-01-18
Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall
Siemens is recalling 41 Biograph mCT PET/CT scanners because laser cover windows may fall off.
Product
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1019-2017·2017-01-18
Acumed Recalls OPT Croutons Synthetic Bone Substitute Due to Sterilization Documentation Issues
Acumed LLC is recalling 83 units of OPT Croutons synthetic bone substitute because documentation for the sterilization dose was inadequate. The product was distributed in ten US states and Puerto Rico.
Product
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
Category
Medical Device
Distribution
9 states

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27926–27950 of 40357