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

40026–40050 of 40356

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
ModerateFDA (Devices)·Z-2119-2012·2012-08-08
Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.
Product
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-2120-2012·2012-08-08
Exactech Recalls Orthopedic Devices Due to Incorrect Shelf Life Labeling
Exactech is recalling specific orthopedic implants because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.
Product
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-2110-2012·2012-08-08
Beekley A-Spots Floral Skin Markers Recalled for Separation Defect
Beekley Corporation is recalling 32,640 units of A-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.
Product
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2129-2012·2012-08-08
ICU Medical Recalls Cardiac Catheterization Waste Management Systems
ICU Medical is recalling Cardiac Catheterization Waste Management Systems due to a molding defect in a high pressure stopcock that could cause side ports to become occluded.
Product
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2117-2012·2012-08-08
Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices because labeling incorrectly states a ten-year shelf life instead of the qualified five-year limit.
Product
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-2114-2012·2012-08-08
Aesculap SIBD Trial Implants Recalled for Incorrect Part Number Etching
Aesculap Implant Systems LLC is recalling 5 SIBD trial implants because the part numbers etched on the instruments may be incorrect, potentially causing selection errors.
Product
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2100-2012·2012-08-08
Advanced Sterilization Products Recalls STERRAD Biological Indicators Due to Shelf-Life Data Gaps
Advanced Sterilization Products is recalling specific lots of STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the product's full labeled shelf-life.
Product
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2109-2012·2012-08-08
Beekley S-Spots Floral Skin Markers Recalled for Separation Defect
Beekley Corporation is recalling 36,518 units of S-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.
Product
Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2122-2012·2012-08-08
Steris Reliance 130 Cart Washer Recall for Door Safety Feature Installation
Steris is recalling 367 Reliance 130 and 130L Cart Washers to install a door close confirmation button and door open delay to ensure proper operation.
Product
The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2101-2012·2012-08-08
Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues
Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgical procedures.
Product
INSTRUMENT ARM DRAPE IS2000, 20 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
ModerateFDA (Devices)·Z-2103-2012·2012-08-08
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,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
ModerateFDA (Devices)·Z-2111-2012·2012-08-08
Beekley O-Spots Floral Skin Markers Recalled for Separation Defect
Beekley Corporation is recalling 267,332 units of O-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.
Product
Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Category
Medical Device
Distribution
Distributed nationwide

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40026–40050 of 40356