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

27501–27525 of 27722

HighFDA (Devices)·Z-2102-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2012·2012-08-08
Integra Advansys Medial Lisfranc Plate Recalled for Surgical Technique Risk
Integra LifeSciences is recalling Advansys Medial Lisfranc Plates because an incorrect surgical technique may cause potential rupture of the tibialis anterior tendon.
Product
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc…
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-2134-2012·2012-08-08
Stryker Recalls 210 RF Cannula Units Due to Packaging Error
Stryker is recalling 210 RF Cannula units because 5mm and 10mm needles were mistakenly packaged in the wrong boxes. This error could lead to thermal skin lesions if the larger tip is used in cervical procedures.
Product
RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2121-2012·2012-08-08
Perkin Elmer Genetic Screening Processor Recalled for Shaker Unit Contamination
Perkinelmer is recalling 78 Genetic Screening Processor units worldwide because shaker unit contamination causes decreased signal activity in neonatal screening assays.
Product
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2012·2012-08-08
Maquet Magnus Carbon-Fibre Operating Table Top Recall for Brake Defect
Maquet is recalling specific Magnus carbon-fibre operating table tops due to a potential issue with motor brakes for the longitudinal shift and tilt drives.
Product
Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2012·2012-08-08
GE OEC Medical Systems Recalls Mobile C-Arm Devices for Hard Disk Drive Issue
GE OEC Medical Systems is recalling OEC MiniView 6800 Mobile C-Arms due to a hard disk drive issue. The recall covers 82 units distributed worldwide.
Product
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2012·2012-08-08
ICU Medical Recalls 94-inch IV Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of 94-inch IV administration sets because a molding defect may cause side ports to become occluded.
Product
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2012·2012-08-08
Baxter Recalls Peritoneal Dialysis Solution Due to Incorrect Inspection Instructions
Baxter Healthcare is recalling Extraneal and DIANEAL Low Calcium peritoneal dialysis solutions because a technical service representative provided incorrect instructions for inspecting solution bags.
Product
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2012·2012-08-08
Abbott i-Stat EG7 Cartridges Recalled for Inaccurate PCO2 Results
Abbott Point of Care is recalling 52,750 i-Stat EG7 cartridges because they may produce falsely low PCO2 readings if stored at room temperature for four weeks or longer.
Product
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2012·2012-08-08
ICU Medical Flush Kits Recalled for Stopcock Molding Defect
ICU Medical is recalling Flush Kits with 3 Way Off Stopcocks due to a molding defect that may occlude side ports.
Product
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2012·2012-08-08
Stryker Recalls RF Cannulas Due to Packaging Error
Stryker is recalling 226 units of RF Cannulas because 5mm and 10mm needles were incorrectly packaged in each other's boxes, posing a risk of thermal skin lesions.
Product
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2065-2012·2012-08-01
GE OEC 8800 Flexview X-ray System Recalled for Safety Issues
GE OEC Medical Systems is recalling OEC 8800 Flexview x-ray systems due to intermittent safety issues including navigation tracking inaccuracy and system lock-up.
Product
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2024-2012·2012-08-01
Respironics Trilogy Ventilators Recalled for Faulty Power Supply Component
Respironics is recalling 173 Trilogy 100, 200, and 202 ventilators due to a potential faulty component in the power supply.
Product
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at…
Category
Medical Device
Distribution
16 states
SevereFDA (Devices)·Z-2040-2012·2012-08-01
GE OEC 6800 Miniview X-ray System Recalled for Safety Issues
GE OEC Medical Systems is recalling 1,933 OEC 6800 Miniview fluoroscopic x-ray systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.
Product
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2082-2012·2012-08-01
Hill-Rom Recalls Affinity Four Birthing Beds Due to Fall Risk
Hill-Rom is recalling 12,726 Affinity Four Birthing Beds because bed movement during labor may cause patient or caregiver falls.
Product
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2076-2012·2012-08-01
CareFusion Alaris PC Unit Model 8015 Recalled for Power Supply Board Error
CareFusion 303, Inc. is recalling Alaris PC unit model 8015 devices because a power supply board component causes startup error codes and alarms.
Product
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2077-2012·2012-08-01
Anspach Effort Recalls Sterile Bone Cutting Burrs Due to Breakage Risk
The Anspach Effort, Inc. is recalling specific sterile bone cutting burrs because the cutter may come apart during use.
Product
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2038-2012·2012-08-01
GE OEC 9800 C-arm Systems Recalled for Power Supply Defect
GE OEC Medical Systems is recalling 8,214 OEC 9800 C-arm systems worldwide because the vertical lift column power supply is defective and subject to early life failure.
Product
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2083-2012·2012-08-01
Philips and Neusoft Recall NeuViz 16 CT Scanners Due to Detached Oil Accumulator
Philips and Neusoft are recalling 15 NeuViz 16 CT scanners because a screw failure caused the oil accumulator to detach from the X-ray tube.
Product
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2068-2012·2012-08-01
Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.
Product
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2073-2012·2012-08-01
Siemens Linear Accelerators Recalled for Potential Radiation Dosing Error
Siemens is recalling 18 ARTISTE and ONCOR linear accelerators due to a rare software issue that could cause radiation beams to be delivered twice.
Product
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2055-2012·2012-08-01
Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure
Terumo CVS is recalling 992 Advanced Perfusion System 1 units due to drive motor failures that trigger alarms. The potential hazards depend on the specific medical application.
Product
System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2012·2012-08-01
Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS System Software
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments when reagent lots are switched.
Product
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Category
Medical Device
Distribution
Distributed nationwide

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27501–27525 of 27722