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

27826–27850 of 40233

HighFDA (Devices)·Z-1003-2017·2017-01-18
Corvida Medical Recalls Halo Closed System Transfer Devices Due to Malfunction
J&J Solutions, Inc. DBA Corvida Medical is recalling 5,520 Halo Closed System Transfer Devices because the needle does not retract. The devices were distributed in Maryland, Texas, and Wisconsin.
Product
Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0989-2017·2017-01-18
Health Robotics Recalls i.v. Station Systems Due to Bag Mislabeling
Health Robotics S.R.L. is recalling 121 i.v. Station and i.v. Station ONCO systems because a motor error caused misalignment and mislabeling of IV bags.
Product
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0951-2017·2017-01-18
Natus Warmette Blanket and Dual Cabinets Recalled for Fuse Failure
Natus Manufacturing Limited is recalling 31 Warmette Blanket and Dual Cabinets because a fuse may blow, causing power loss and potential melting of the fuse cover.
Product
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0956-2017·2017-01-18
Zimmer Biomet Recalls Oxford Fixed Lateral Bearings Due to Mislabeling
Zimmer Biomet is removing a specific lot of Oxford Fixed Lateral Bearings because packages labeled as 'Right' contained 'Left' bearings.
Product
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed.…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0965-2017·2017-01-18
ASP Recalls EVOTECH Endoscope Cleaner Due to Hose Leak Risk
Advanced Sterilization Products is recalling 107 EVOTECH Endoscope Cleaner and Reprocessor Systems because a hose may come loose and cause a leak.
Product
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1017-2017·2017-01-18
Merge Eye Station Software Recalled for Potential Data Deletion
Merge Healthcare is recalling Merge Eye Station software versions 11.6.0 and prior due to a risk of accidental patient record deletion.
Product
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
Category
Medical Device
Distribution
52 states
ModerateFDA (Devices)·Z-0954-2017·2017-01-18
In2Bones Recalls NEOVIEW Screws Due to Thread Dimensional Non-Conformity
In2Bones is recalling 26 units of NEOVIEW Screws Set due to dimensional non-conformity of the thread on the screw head.
Product
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0952-2017·2017-01-18
In2Bones Recalls 19 Locking Screws Due to Thread Dimensional Non-Conformity
In2Bones is recalling 19 locking screws from the NEOVIEW Plating System due to dimensional non-conformity of the thread on the screw head.
Product
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1002-2017·2017-01-18
Siemens Biograph mCT Flow 40-4R Laser Cover Window Recall
Siemens Medical Solutions is recalling Biograph mCT Flow 40-4R scanners because laser cover windows may fall off.
Product
Biograph mCT Flow 40-4R, Material Number 10529159 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-0957-2017·2017-01-18
Straumann Dental Implant Drills Recalled for Tolerance Specification Failures
Straumann Manufacturing is recalling 165 dental implant drills because they cannot be inserted into handpieces due to tolerance specification failures.
Product
Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0979-2017·2017-01-18
Siemens Recalls Intact PTH Assay Kits Due to Negative Bias
Siemens is recalling IMMULITE 2000 Intact PTH assay kits because they may show a negative bias of up to -39% at low concentrations.
Product
SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0991-2017·2017-01-18
ConforMIS iTotal PS Knee Implant Recalled for Software Measurement Error
ConforMIS is recalling iTotal PS Knee Replacement Kits because the iView software displayed femoral cut measurements in the wrong unit.
Product
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0975-2017·2017-01-18
GE OEC Mobile Fluoroscopy Systems Recalled for Power Cable Failures
GE Healthcare is recalling OEC 9900 Elite and other mobile fluoroscopy systems because the workstation power cable assembly can fail intermittently.
Product
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic…
Category
Medical Device
Distribution
50 states
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

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