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

18576–18600 of 27647

HighFDA (Devices)·Z-0989-2018·2018-03-21
Alden Classic 55 Toric Contact Lenses Recalled for Sterility Issues
Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
Product
Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0968-2018·2018-03-21
BD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Additive Deficiency
Becton Dickinson is recalling specific lots of BD Vacutainer K2 EDTA blood collection tubes because they may contain insufficient anticoagulant, potentially causing erroneous test results.
Product
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2018·2018-03-14
FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error
The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.
Product
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0909-2018·2018-03-14
Roche cobas 6000 Modular Series System Warning Added to Prevent Operator Injury
Roche Diagnostics is adding a warning to cobas 6000 and 8000 Modular Series Operator Manuals to prevent operator injury during maintenance.
Product
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0922-2018·2018-03-14
Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results
Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.
Product
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0903-2018·2018-03-14
Synthes Reaming Rods Recalled for Potential Sterility Seal Defects
Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.
Product
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2018·2018-03-14
Abbott Recalls ARCHITECT c16000 Cuvette Segments Due to Falsely Depressed Results
Abbott Laboratories is recalling cuvette segments for the ARCHITECT Clinical Chemistry system because detached segment posts may cause falsely depressed patient test results.
Product
ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2018·2018-03-14
Medtronic O-arm O2 Imaging System Recalled for Electrical Shock Risk
Medtronic is recalling 449 O-arm O2 Imaging Systems because servicing internal components may cause an electrical short, posing a shock hazard to field service technicians.
Product
O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2018·2018-03-14
Mindray A-Series Anesthesia Delivery System Software Recall
Mindray is recalling 2,875 A-Series anesthesia delivery systems due to a software issue that may apply incorrect settings or skip startup leak tests.
Product
A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0844-2018·2018-03-14
Toshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening
Toshiba American Medical Systems is recalling 29 INFX-8000V and INFINIX CF-I/BP PLUS systems because fastening bolts on the ceiling drive loosened, disabling operation.
Product
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0907-2018·2018-03-14
Synthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility
Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic surgery.
Product
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2018·2018-03-14
Mindray A7 Anesthesia Delivery System Recalled for Software Defect
Mindray is recalling A7 Anesthesia Delivery Systems because a software issue may cause incorrect settings to be applied or the startup leak test to be skipped.
Product
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2018·2018-03-14
Zimmer Biomet Recalls Sirus Drill Instruments Due to Cleaning Concerns
Zimmer Biomet is recalling 127 Sirus Drill instruments because they may not be adequately cleaned, potentially leading to infection.
Product
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0840-2018·2018-03-14
Philips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors
Philips Medical Systems is recalling 11 Brilliance Big Bore Oncology CT scanners due to software errors that may affect image generation and display settings.
Product
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 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.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0863-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling LASEREDGE Knives for ophthalmic surgery because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.
Product
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0839-2018·2018-03-14
Philips Brilliance Big Bore CT Software Recall for Image Generation Errors
Philips is recalling 119 Brilliance Big Bore CT scanners due to software errors that may prevent image generation or display incorrect settings.
Product
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 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.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0842-2018·2018-03-14
Toshiba INFX-8000F Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
Toshiba is recalling 17 INFX-8000F Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
Product
INFX-8000F Fluoroscopic X-Ray Systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0843-2018·2018-03-14
Toshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
Toshiba American Medical Systems Inc is recalling 19 INFX-8000C Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
Product
INFX-8000C Fluoroscopic X-Ray Systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0835-2018·2018-03-14
Stryker Recalls StrykeFlow 2 System Due to Bioburden Testing Results
Stryker is recalling 60,753 units of the StrykeFlow 2 System because routine bioburden testing found levels higher than internal acceptable rates.
Product
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0921-2018·2018-03-14
Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results
Abbott is recalling ARCHITECT c4000 Cuvette Segments because a detached post can cause falsely depressed patient results in adjacent cuvettes.
Product
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0906-2018·2018-03-14
Synthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns
Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product sterility.
Product
2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0851-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.
Product
LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0849-2018·2018-03-14
DePuy Concorde Lift Torque Limiting Handle Recalled for Breakage Risk
DePuy Orthopaedics is recalling 130 Concorde Lift Torque Limiting Handles due to a potential for intra-operative breakage of driver tips.
Product
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2018·2018-03-14
Synthes Reaming Rods Recalled for Potential Sterility Seal Defects
Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects may compromise sterility.
Product
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0902-2018·2018-03-14
Synthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss
Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.
Product
2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide

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