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

26726–26750 of 40233

HighFDA (Devices)·Z-2100-2017·2017-05-24
Mobius3D Software Recalled for Dose Calculation Defect in Radiation Therapy
Mobius Medical Systems is recalling Mobius3D software versions 1.5.0 and 1.5.2 due to a code defect that may cause dose calculation discrepancies in radiation therapy.
Product
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2017·2017-05-24
Vortran Automatic Resuscitator Recalled Due to Reverse-Threaded Oxygen Connector
Vortran is recalling 14 cases of VARPlus Automatic Resuscitators because the oxygen tubing connector was assembled in reverse, preventing it from being screwed on.
Product
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2110-2017·2017-05-24
Molnlycke Recalls Brennen Skin Graft Mesher Due to Sterilization Failure
Molnlycke Health Care is recalling 956 units of the Brennen Skin Graft Mesher because of a sterilization validation failure. The instruments were distributed domestically and internationally.
Product
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2017·2017-05-24
Medline Recalls 10 mm Distraction Pins Due to Sterile Seal Concerns
Medline Industries is recalling 10 mm Distraction Pins because the sterile packaging seal may be compromised, potentially causing the device to lose sterility.
Product
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2017·2017-05-24
Luminex ARIES System Recalled for Barcode Scanner Data Error
Luminex Corporation is recalling 15 ARIES Systems because a barcode scanner accessory may incorrectly populate patient sample IDs with previously scanned data.
Product
ARIES System and ARIES M1 System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2083-2017·2017-05-24
Beckman Coulter Recalls Triglycerides Reagent Due to Interference
Beckman Coulter is recalling Triglycerides Reagent because specific drugs can cause false low results.
Product
Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2084-2017·2017-05-24
Beckman Coulter Recalls Salicylate Reagent Due to Drug Interference
Beckman Coulter is recalling Salicylate Reagent (Catalog No. 378194) because specific drugs can cause false low results in salicylate testing.
Product
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2075-2017·2017-05-24
Zimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies
Zimmer CAS is voluntarily recalling 152 units of the Navitrack System - OS Knee Universal due to software anomalies corrected in a new revision.
Product
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-2085-2017·2017-05-24
Siemens Recalls Insulin Calibrators Due to Measurement Deviation
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Insulin Calibrators because they measure approximately 40% higher than the WHO standard.
Product
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2104-2017·2017-05-24
Medline Recalls Distraction Pins Due to Potential Sterility Loss
Medline Industries is recalling 2,112 packs of sterile distraction pins because the packaging seal may be compromised, risking loss of sterility.
Product
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2081-2017·2017-05-24
Beckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference
Beckman Coulter is recalling Cholesterol Reagent (Catalog No. 467825) because specific drugs may cause false low results.
Product
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2107-2017·2017-05-24
Medline 12 mm Distraction Pin Recalled for Potential Sterility Loss
Medline Industries is recalling 300 packs of 12 mm Distraction Pins because the sterile packaging seal may be compromised, potentially allowing the device to lose sterility.
Product
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2115-2017·2017-05-24
Zimmer Biomet Recalls NexGen Offset Stem Extension Implants Due to Labeling Errors
Zimmer Biomet is recalling specific lots of NexGen Offset Stem Extension implants because the size etched on the parts and packaging was incorrect.
Product
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2073-2017·2017-05-24
Biomet Microfixation Recalls Surgical Trays Due to Part Number Mismatch
Biomet Microfixation is recalling 33 TraumaOne System Surgical Trays because the part number on the lid differs from the base.
Product
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2076-2017·2017-05-24
Zimmer CAS Recalls Navitrack System OS Knee Universal Software
Zimmer CAS is voluntarily recalling Navitrack System OS Knee Universal software versions due to software issues causing errors and discrepancies.
Product
Navitrack System - OS Knee Universal, Stereotaxic instrument
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2086-2017·2017-05-24
Siemens Recalls ADVIA Centaur Insulin Assay Kits Due to Accuracy Issues
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Insulin ReadyPacks because the assay results are approximately 40% higher than the WHO standard. The company states the overall risk to health is negligible.
Product
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2108-2017·2017-05-24
Teleflex Recalls Visistat Skin Staplers Due to Labeling Error
Teleflex Medical is recalling Visistat 35R Disposable Skin Staplers because some boxes are mislabeled as containing Wide devices when they contain Regular devices.
Product
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular…
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-1893-2017·2017-05-24
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm Recalled for Missing Label Date
Ziehm Imaging Inc is recalling two solo FD Mobile Fluoroscopic C-arm systems because the labels for the Collimator and X-ray Control panel are missing the manufacturer date.
Product
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2082-2017·2017-05-24
Beckman Coulter Recalls HDL Cholesterol Reagent Due to Drug Interference
Beckman Coulter is recalling HDL Cholesterol Reagent because specific drugs can cause false low results.
Product
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2102-2017·2017-05-24
Medical Action Industries Recalls Blue OR Towels Due to Lint Presence
Medical Action Industries is recalling specific lots of Blue OR Towels because lint was found on the sterile towels.
Product
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2090-2017·2017-05-24
Hitachi Arietta 70 Ultrasound System Recalled for Weak Arm Mounting Mechanism
Hitachi Medical Systems America Inc is recalling 77 Arietta 70 Ultrasound Systems because the arm mounting mechanism was insufficiently strong and required redesign.
Product
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2080-2017·2017-05-24
Beckman Coulter Recalls Enzymatic Creatinine Reagent Due to Interference
Beckman Coulter is recalling Enzymatic Creatinine Reagent because specific drugs can cause false low results. The recall affects 12,665 units distributed worldwide.
Product
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2079-2017·2017-05-24
Beckman Coulter Recalls Uric Acid Reagent Due to Drug Interference
Beckman Coulter is recalling Uric Acid Reagent because certain drugs can cause false low results. The recall covers 100,286 units distributed worldwide.
Product
Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2078-2017·2017-05-24
Beckman Coulter Recalls Lactate Reagent Due to Interference from Specific Drugs
Beckman Coulter is recalling Lactate Reagent (Catalog No. A95550) because certain drugs can cause false low results.
Product
Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2101-2017·2017-05-24
Medical Action Industries Recalls Sterile Operating Room Towels Due to Lint
Medical Action Industries is recalling sterile operating room towels because lint is present on the product.
Product
White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
Category
Medical Device
Distribution
3 states

How to read this listing

Filters

26726–26750 of 40233