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 deaths or serious injuries are reported, 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

3901–3925 of 5111

SevereFDA (Devices)·Z-2703-2016·2016-09-14
MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling 38 units of Advance II Modular Tibial Bases because they are experiencing a higher than expected revision rate due to component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2717-2016·2016-09-14
Aribex Recalls NOMAD Pro2 X-Ray Systems Due to Battery Fire Risk
Aribex Inc is recalling 16,871 NOMAD Pro2 X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, smoke, or ignition.
Product
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GB
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-2701-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2698-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sys
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2695-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2716-2016·2016-09-14
Aribex Recalls NOMAD Pro X-Ray Systems Due to Battery Fire Risk
Aribex Inc is recalling NOMAD Pro X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, melting, smoking, or ignition.
Product
NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-2699-2016·2016-09-14
MicroPort Recalls Advance II Modular Tibial Base Components
MicroPort Orthopedics is recalling Advance II Modular Tibial Base components due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2702-2016·2016-09-14
MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling 47 units of Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sy
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2696-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sy
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2768-2016·2016-09-14
Bayer Certegra Workstation Recalled for Fire and Smoke Risk
Bayer Healthcare is recalling 165 Certegra Workstations used with Medrad Stellant CT Injection Systems because they may produce smoke and sparks of fire.
Product
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2697-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2675-2016·2016-09-07
Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.
Product
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2692-2016·2016-09-07
Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Due to Fire Risk
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer because flammable liquids may contact electrical components, posing a fire hazard.
Product
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a who
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2677-2016·2016-09-07
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported shaft rotation interruptions and jaw opening failures.
Product
CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2681-2016·2016-09-07
Philips PCR Compano Basic Reader Recalled for Power Supply Fire Hazard
Philips is recalling 388 PCR Compano Basic Reader units because a defective power supply component can burn and release smoke.
Product
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Category
Medical Device
Distribution
41 states
SevereFDA (Devices)·Z-2676-2016·2016-09-07
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported field failures involving shaft rotation interruption or jaws not opening.
Product
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation o
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2613-2016·2016-08-31
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture
Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.
Product
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2622-2016·2016-08-31
Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture
Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2665-2016·2016-08-31
Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their batteries may overheat, melt, or char.
Product
Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity mea
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2597-2016·2016-08-31
Conmed Pediatric ThermoGard Electrodes Recalled for Burn Risk
Conmed is recalling Pediatric ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
Product
Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2649-2016·2016-08-31
Bovie Precise 360 Handpiece Recalled Due to Incomplete Tip Bond
Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
Product
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2618-2016·2016-08-31
Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture
Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2662-2016·2016-08-31
Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader because the batteries may overheat, melt, or char.
Product
Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain informati
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2616-2016·2016-08-31
Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets
Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.
Product
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2596-2016·2016-08-31
Conmed Dual Dispersive Electrodes Recalled for Burn Risk
Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
Product
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states

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3901–3925 of 5111