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

21676–21700 of 40299

HighFDA (Devices)·Z-0542-2019·2018-12-12
Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 1,676 Pressure Sentinel Guide Wires because creases in the packaging seal may compromise sterility. The defect could increase the risk of infection during orthopaedic surgery.
Product
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2019·2018-12-12
Siemens Artis Zee and Zeego X-ray Systems Recalled for Cooling Hose Leak
Siemens is recalling 64 Artis Zee and Zeego angiography systems due to a possible cooling hose leak that can cause the X-ray tube to overheat and block imaging.
Product
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is 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
12 states
HighFDA (Devices)·Z-0560-2019·2018-12-12
Atrium Medical Recalls 28Fr Thoracic Catheters Due to Seal Defect
Atrium Medical Corporation is recalling 2,930 units of 28Fr PVC Thoracic Catheters due to a seal defect in sterile barrier pouches that could compromise sterility.
Product
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0534-2019·2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 9,387 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area compromise product sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2019·2018-12-12
Philips Brilliance 16 Slice CT Scanner Recalled for Gantry Cover Separation Risk
Philips Medical Systems is recalling 6,343 Brilliance 16 Slice CT scanners nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.
Product
Brilliance 16 Slice (Power), Model 728240 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2019·2018-12-12
Barco Front Cover Attachment Kit Recalled for Potential Falling Hazard
Barco N.V. is recalling 2,087 MDRC-1119 Front Cover Attachment Kits because metal strips may deform, causing the protective cover to fall.
Product
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0525-2019·2018-12-12
ASO Recalls Family Wellness Sterile Gauze Pads Due to Sterilization Concerns
ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.
Product
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0550-2019·2018-12-12
Capintec Recalls Captus 3000 Thyroid Uptake Systems Due to Spring Arm Failure
Capintec Inc is recalling 385 Captus 3000 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.
Product
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0531-2019·2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling specific lots of M/DN Intramedullary Fixation Humeral Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2019·2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0530-2019·2018-12-12
Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling Pressure Sentinel Guide Wires because creases in the sealing area compromise product sterility. The recall affects 48,320 units distributed worldwide.
Product
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0537-2019·2018-12-12
Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.
Product
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2019·2018-12-12
Philips Brilliance 10 Slice CT Scanner Recalled for Gantry Cover Failure Risk
Philips is recalling Brilliance 10 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover and metal support to fail or fall.
Product
Brilliance 10 Slice (Air), Model 728251 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2019·2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Concerns
Zimmer Biomet is recalling 12,724 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0548-2019·2018-12-12
Philips Brilliance 6 Slice CT Scanner Recalled for Gantry Cover Separation Risk
Philips Medical Systems is recalling Brilliance 6 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.
Product
Brilliance 6 Slice (Air), Model 728256 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0557-2019·2018-12-12
Stephanix D2RS Digital Dynamic Remote System Recalled for Table Movement Risk
Stephanix is recalling 17 D2RS Digital Dynamic Remote Systems because the table may continue moving after a command is released.
Product
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2019·2018-12-12
Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires
Zimmer Biomet is recalling Natural Nail System Tear Drop Guide Wires due to creases in the sealing area that compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0546-2019·2018-12-12
Philips Brilliance 16 Slice CT Scanner Recall for Cover Separation
Philips is recalling Brilliance 16 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.
Product
Brilliance 16 Slice (Air), Model 728246 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0543-2019·2018-12-12
Philips Brilliance 64 CT Scanner Recall for Gantry Cover Separation Risk
Philips Medical Systems is recalling Brilliance 64 CT scanners due to a potential fiberglass resin separation that could cause the gantry front cover to fail and fall.
Product
Brilliance 64, Model 728231 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0553-2019·2018-12-12
Zimmer Biomet Recalls 20mm Compress Device Short Anchor Plug
Zimmer Biomet is recalling 6 units of the 20mm Compress Device Short Anchor Plug due to potential metal burrs that may prevent proper insertion of drill and transverse pins.
Product
Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0556-2019·2018-12-12
Pfizer Recalls Thermacare Heatwraps Due to Material Leakage
Pfizer is recalling specific lots of Thermacare Heatwraps because the wraps may come apart and leak granular material.
Product
Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0555-2019·2018-12-12
Pfizer Recalls Thermacare HeatWraps Menstrual Due to Material Leakage
Pfizer is recalling Thermacare HeatWraps Menstrual because the wraps may come apart and leak granular material.
Product
Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0559-2019·2018-12-12
Tosoh AIA-360 Analyzer Recalled for Labeling Clarifications on Maintenance Requirements
Tosoh Bioscience is recalling 1,228 AIA-360 Analyzers to update labeling and training materials regarding maintenance and reagent requirements.
Product
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0528-2019·2018-12-12
Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Growth Inhibition
Becton Dickinson is recalling 54,300 plates of Trypticase Soy Agar with 5% Sheep Blood because a manufacturing error inhibited the growth of Gram-negative organisms.
Product
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0561-2019·2018-12-12
Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards
Helena Laboratories is recalling 27 kits of Cascade Abrazo c-ACT-LR Test Cards due to reported variations in test results.
Product
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
Category
Medical Device
Distribution
1 state

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21676–21700 of 40299