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

21751–21775 of 40175

HighFDA (Devices)·Z-0409-2019·2018-11-14
Siemens Dimension Thermal Chamber Motor Cable Recall for Insulation Defect
Siemens is recalling 277 Dimension thermal chamber motor cables worldwide due to single insulation instead of required double insulation, posing a potential electrical shock risk.
Product
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0393-2019·2018-11-14
Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error
Zimmer Biomet is recalling 12,825 units of the RapidFlap System 12mm SpinDown Clamp because the nut was assembled incorrectly. The defect affects sterile clamps used for craniotomy bone flap re-attachment.
Product
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0387-2019·2018-11-14
Becton Dickinson Recalls PCEA Administration Sets Due to Potential Leaks
Becton Dickinson is recalling PCEA Administration Sets because they may leak at the connection point. The recall covers 566,737 units distributed worldwide.
Product
PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0406-2019·2018-11-14
Medtronic CareLink 2090 Programmer Recalled for Software Vulnerability
Medtronic is recalling CareLink 2090 Programmers worldwide due to a vulnerability that allows unauthorized software updates during the SDN download process.
Product
Medtronic CareLink 2090 Programmer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0373-2019·2018-11-14
Howmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk
Howmedica Osteonics Corp. is recalling 15 pouches of sterile knee instruments because the outer sterile barrier may be compromised.
Product
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0408-2019·2018-11-14
Accuray Recalls CyberKnife M6 Systems Due to Wrist Component Failure Risk
Accuray is recalling 93 CyberKnife M6 systems worldwide due to manufacturing variations in the robot wrist that may cause premature component failure.
Product
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0386-2019·2018-11-14
Becton Dickinson Recalls PCEA ASV Yellow Microbore Administration Sets
Becton Dickinson is recalling PCEA ASV Yellow Microbore administration sets because they may leak at the luer lock connection.
Product
PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0394-2019·2018-11-14
Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error
Zimmer Biomet is recalling RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The defect affects 11,736 units distributed worldwide.
Product
Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0379-2019·2018-11-14
AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 4x5 due to a potential for pouch seal failure.
Product
Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0401-2019·2018-11-14
Safe N Simple Recalls Hydrogel Wound Dressings Due to Sterilization Issues
Safe N Simple, LLC is recalling 125 cases of Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified. The affected products were distributed in California.
Product
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0399-2019·2018-11-14
Zimmer Biomet Recalls StageOne Hip Cement Spacer Molds
Zimmer Biomet is recalling 72 units of StageOne Hip cement spacer molds due to a potential for comingling of 43MM and 51MM sizes.
Product
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0382-2019·2018-11-14
Randox Recalls Liquid Cardiac Control CQ5053 Due to Unacceptable Variation
Randox Laboratories is recalling Liquid Cardiac Control CQ5053 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
Product
Liquid Cardiac Control, CQ5053
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0402-2019·2018-11-14
DT MedTech Recalls Ankle Joint Inlays Due to Incorrect Package Labeling
DT MedTech is recalling 54 units of Hintermann Series H3 Poly Inlays because the package labeling incorrectly identifies the device.
Product
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0400-2019·2018-11-14
Simpurity Hydrogel Wound Dressing Recalled Due to Unqualified Sterilization Process
Safe N Simple, LLC is recalling Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified.
Product
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0392-2019·2018-11-14
Ortho-Clinical Diagnostics Recalls VITROS Vitamin B12 Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Reagent Packs due to a potential for increased calibration failures.
Product
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0383-2019·2018-11-14
Qiagen EZ1 Advanced XL Recalled for Potential Heater Malfunction
Qiagen is recalling 298 EZ1 Advanced XL instruments due to a power board defect that may cause heater malfunctions and compromise nucleic acid extractions.
Product
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0385-2019·2018-11-14
CareFusion Recalls Alaris Infusion Pump Administration Sets Due to Priming Issues
CareFusion 303, Inc. is recalling Alaris Infusion Pump administration sets because users reported being unable to prime the devices.
Product
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0380-2019·2018-11-14
Randox Liquid Cardiac Control CQ5051 Recalled for Unacceptable Variation
Randox Laboratories is recalling Liquid Cardiac Control CQ5051 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
Product
Liquid Cardiac Control, CQ5051
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0403-2019·2018-11-14
DT MedTech Recalls Ankle Implant Due to Incorrect Package Labeling
DT MedTech is recalling specific talar implants for ankle joints because the package labels incorrectly identify the device.
Product
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0376-2019·2018-11-14
Coltene Whaledent Recalls ParaPost Plus Titanium Dental Posts
Coltene Whaledent Inc is recalling ParaPost Plus 25 Titanium Alloy dental posts because they contain stainless steel posts that are a size 4.
Product
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0374-2019·2018-11-14
GE Healthcare Recalls Centricity PACS-IW Software Due to Synchronization Failure
GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.
Product
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0381-2019·2018-11-14
Randox Recalls Liquid Cardiac Control CQ5052 Due to Unacceptable Variation
Randox Laboratories is recalling Liquid Cardiac Control CQ5052 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
Product
Liquid Cardiac Control, CQ5052
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0404-2019·2018-11-14
Medtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall
Medtronic Navigation is recalling 641 O-arm 02 Imaging Systems to correct software version 4.1.0, update manuals and labels, and replace blown fuses in the AC power input circuit.
Product
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0377-2019·2018-11-14
AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
AROA Biosurgery is recalling Endoform Dermal Template 2x2 units due to a potential for pouch seal failure.
Product
Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0405-2019·2018-11-14
Integrity Implants Recalls FlareHawk Interbody Fusion System Instructions for Use
Integrity Implants is correcting Instructions for Use for the FlareHawk Interbody Fusion System due to discrepancies in cleaning parameters.
Product
FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.
Category
Medical Device
Distribution
Distributed nationwide

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21751–21775 of 40175