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

18601–18625 of 27682

HighFDA (Devices)·Z-0892-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blade Complaints
Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G, 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-0918-2018·2018-03-14
Zimmer Biomet Flexible Shaft Instruments Recalled for Infection Risk
Zimmer Biomet is recalling 457 Flexible Shaft instruments because they may not clean adequately, posing a risk of infection.
Product
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0910-2018·2018-03-14
Roche cobas 8000 Modular Analyzer Recall for Operator Injury Prevention
Roche Diagnostics is recalling 245 cobas 8000 c 502 modules to add a warning to the manual, preventing operator injury during maintenance.
Product
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0901-2018·2018-03-14
Synthes Reaming Rods Recalled for Potential Sterility Seal Defects
Synthes (USA) Products LLC is recalling 2.5 mm Reaming Rods because package seal defects may have compromised sterility. The devices are used in orthopedic surgery.
Product
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0837-2018·2018-03-14
Stryker Recalls ACL Interface Screws Due to Bioburden Levels
Stryker is recalling specific lots of ACL Interface Screws because routine testing found bioburden levels higher than internal acceptable rates.
Product
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0841-2018·2018-03-14
Philips IQon Spectral CT Software Recall for Image Misrepresentation
Philips is recalling 63 IQon Spectral CT systems due to software errors that may cause image misrepresentation or failure to generate images.
Product
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0900-2018·2018-03-14
Medtronic BIO CAL Temperature Controller Recalled Due to Cleaning Protocol Issues
Medtronic is recalling BIO CAL Temperature Controllers because it cannot develop a cleaning protocol that meets current industry standards. Users are advised to discontinue use and dispose of the devices.
Product
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0738-2018·2018-03-07
Ventana Hematoxylin II and HRP Dispensers Recalled for Leaking and Sticking
Ventana Medical Systems is recalling Hematoxylin II and specific HRP dispensers due to increased reports of leaking and sticking.
Product
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0775-2018·2018-03-07
Zimmer Biomet Recalls 337 Femoral Intramedullary Nail Loaner Kits
Zimmer Biomet is recalling 337 femoral intramedullary nail loaner kits because the bolt connecting the insertion guide to the nail can fracture during insertion.
Product
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1171-2018·2018-03-07
Circulatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs
Circulatory Technology Inc is recalling specific models of cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.
Product
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-0732-2018·2018-03-07
Ventana ultraView SISH Detection Kit Recalled for Leaking Reagent Dispensers
Ventana Medical Systems is recalling 6 units of the ultraView SISH Detection Kit due to increased reports of leaking and sticking reagent dispensers.
Product
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0774-2018·2018-03-07
Zimmer Biomet Recalls Antegrade Femoral Nail Instrument Kits
Zimmer Biomet is recalling 337 Antegrade Femoral Nail Instrument Kits because a bolt may fracture during use, potentially affecting patients undergoing orthopedic surgery.
Product
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0740-2018·2018-03-07
Ventana Medical Systems Recalls NEXES VEN IVIEW DAB DET KT JPN-US EXPORT
Ventana Medical Systems is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT in vitro diagnostic kits due to increased reports of leaking and sticking reagent dispensers.
Product
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0739-2018·2018-03-07
Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers
Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.
Product
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0719-2018·2018-03-07
Medistim Veriq System Recalled Due to Component Overheating and Smoke Emission
Medistim Asa is recalling two Medistim Veriq System units because a component overheated, causing connector melting and smoke emission.
Product
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0817-2018·2018-03-07
Circulatory Technology Recalls Better-Bladder ECMO Blood Reservoirs
Circulatory Technology Inc is recalling Better-Bladder cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.
Product
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-0734-2018·2018-03-07
Ventana Recalls CINtec PLUS Cytology Kit Due to Leaking Reagent Dispensers
Ventana Medical Systems is recalling 748 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.
Product
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0713-2018·2018-03-07
Siemens SOMATOM Go.Up CT Table Recall for Potential Instability
Siemens Medical Solutions is recalling six SOMATOM Go.Up CT system tables because improperly tightened bolts may loosen, causing the table to become unstable.
Product
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0715-2018·2018-03-07
Mobius AIRO Mobile CT System Recalled for Unintended Motion Risk
Mobius Imaging is recalling 105 AIRO Mobile CT Systems due to a risk of unintended device motion during startup or scan preparation.
Product
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0736-2018·2018-03-07
Ventana OptiView Amplification Kit Recalled for Leaking and Sticking Reagent Dispensers
Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.
Product
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0731-2018·2018-03-07
Ventana iView DAB IHC Detection Kit Recalled for Leaking and Sticking
Ventana Medical Systems is recalling iView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Product
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0729-2018·2018-03-07
Ventana OptiView DAB IHC Detection Kit Recalled for Leaking and Sticking
Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Product
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0737-2018·2018-03-07
Ventana OptiView Amplification Kit Recalled for Leaking and Sticking Reagent Dispensers
Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.
Product
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0733-2018·2018-03-07
Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers
Ventana Medical Systems is recalling 20 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.
Product
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0730-2018·2018-03-07
Ventana ultraView Universal DAB Detection Kit Recalled for Leaking Reagent Dispensers
Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Product
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide

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18601–18625 of 27682