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

27851–27875 of 40233

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
ModerateFDA (Devices)·Z-0997-2017·2017-01-18
Siemens Biograph mCT X-3R Scanners Recalled for Falling Laser Cover Windows
Siemens Medical Solutions is recalling 18 Biograph mCT X-3R scanners because laser cover windows may fall off.
Product
Biograph mCT X-3R, Material Number 10248673 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
LowFDA (Devices)·Z-1004-2017·2017-01-18
Philips Brilliance iCT CT System Recalled for Undocumented Installation
Philips Medical Systems is recalling one Brilliance iCT system because the installation of four M12 bolts was not correctly documented.
Product
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0926-2017·2017-01-11
Nurse Assist Recalls Normal Saline Flush Syringes Due to B. cepacia Contamination
Nurse Assist, Inc. is recalling Normal Saline Flush syringes due to potential contamination with B. cepacia. The affected products were distributed in the US, US Virgin Islands, and Canada.
Product
Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2017·2017-01-11
Pride Mobility Recalls TRU-Balance 3 Power Positioning Systems
Pride Mobility Products Corp is recalling 12,343 TRU-Balance 3 Power Positioning Systems because the back and tilt base can separate when tilted beyond the specified angle.
Product
TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2017·2017-01-11
Smith & Nephew Recalls Modular Hip Prosthesis Necks Due to Adverse Events
Smith & Nephew is recalling 13,671 modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend.
Product
Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2017·2017-01-11
Smith & Nephew Recalls Modular SMF Hip Prostheses Due to Adverse Events
Smith & Nephew is recalling Modular SMF and Modular REDAPT Hip Systems due to a higher-than-anticipated trend in complaints and adverse events.
Product
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2017·2017-01-11
Smith & Nephew Recalls Modular REDAPT Hip Systems Due to Adverse Events
Smith & Nephew is recalling 6,266 units of Modular REDAPT and Modular SMF Hip Systems worldwide due to a higher than anticipated complaint and adverse event trend.
Product
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2017·2017-01-11
Boston Scientific Recalls INGEVITY MRI Pacing Leads Due to Connection Defect
Boston Scientific is recalling INGEVITY MRI endocardial pacing leads because the polyurethane boot may not be securely connected to the lead body.
Product
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0941-2017·2017-01-11
Interventional Spine Recalls G3 Opticage Expandable Interbody Fusion Devices
Interventional Spine Inc is recalling 239 G3 Opticage Expandable Interbody Fusion Devices because the proximal end may separate during implantation, preventing the device from expanding.
Product
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0939-2017·2017-01-11
Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association
Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.
Product
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0947-2017·2017-01-11
Aesculap Recalls Gomco Circumcision Clamps Due to Excessive Bleeding Reports
Aesculap Implant Systems LLC is recalling 437 units of Gomco Circumcision Clamps nationwide after receiving complaints of excessive bleeding following use.
Product
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0948-2017·2017-01-11
Tepha GalaSHAPE 3D Medical Device Recalled for Endotoxin Specification Exceedance
Tepha Incorporated is recalling 29 units of GalaSHAPE 3D medical devices because endotoxin levels slightly exceeded specifications.
Product
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the…
Category
Medical Device
Distribution
Distributed nationwide

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27851–27875 of 40233