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

13801–13825 of 13836

HighFDA (Devices)·Z-1772-2021·2021-06-09
MiniMed 670G Insulin Pump Software Flaw Risks Insulin Overdose
A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.
Product
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 0
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1781-2021·2021-06-09
Tranberg MR Stylet Recalled Due to Inadequate Sterilization
CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylet devices (lot IDs 116540030718 and 116540201117) because single-use units labeled as sterile may not have been adequately sterilized, creating infection risk.
Product
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1775-2021·2021-06-09
Synapse Cardiovascular software may incorrectly reuse patient database identifiers
Fujifilm's Synapse Cardiovascular software versions 6.0.4 to 6.2.1 contain a defect in the Advanced Reporting function where previously assigned patient database identification numbers can be reused for new patients when specific patient merge operations are executed.
Product
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2021·2021-06-09
10 Gauge Drill for Orthopedic Surgery Recalled for Sterilization Failure
Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.
Product
10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2021·2021-06-09
Zavation 10G Direct Single Bone Access Kit Recall Due to Inadequate Sterilization
Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.
Product
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1757-2021·2021-06-09
ZVplasty System spinal implant devices recalled for inadequate sterilization
Zavation is recalling 31 ZVplasty System spinal implant devices that may not have been adequately sterilized. Patients who received these implants should contact their physician.
Product
ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1713-2021·2021-06-09
Zavation surgical bone access kit recalled due to inadequate sterilization
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Patients who received these devices should contact their healthcare provider.
Product
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1788-2021·2021-06-09
Nimbus alternating-pressure mattress overlay system recall for inflation malfunction
Getinge is recalling approximately 13,042 units of Nimbus 4 and Nimbus Professional alternating-pressure mattress overlays due to potential abnormal inflation that could impair pressure relief function.
Product
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1776-2021·2021-06-09
Oral Surgery Scrapers Recalled Due to Potential Sterility Failure
Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scrapers distributed in Texas and Florida due to sterility concerns. The single-use sterile devices may not have been adequately sterilized.
Product
REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1727-2021·2021-06-09
Orthopedic spinal surgical device recalled for inadequate sterilization
Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.
Product
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1725-2021·2021-06-09
ZVplasty Directional Cement Cannula Long may lack adequate sterilization
Zavation is recalling 27 units of ZVplasty Directional Cement Cannula Long (Lot 20061365) used in orthopedic and spinal procedures due to inadequate sterilization. Products were distributed nationwide as sterile but may not have undergone proper sterilization processing.
Product
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2021·2021-06-09
Zavation 10G Cement Delivery Cannula Recalled for Inadequate Sterilization
Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.
Product
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1712-2021·2021-06-09
ZVplasty Direct Access Trocar Recalled for Inadequate Sterilization
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.
Product
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2021·2021-06-09
Zavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized
Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to infection.
Product
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2021·2021-06-09
11G Beveled Trocars and Cannulas Recalled for Possible Inadequate Sterilization
Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal procedures. These surgical instruments may not have been adequately sterilized, posing a potential safety risk.
Product
11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2021·2021-06-09
Orthopedic Bone Access Tools May Lack Proper Sterilization
Zavation is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.
Product
InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1761-2021·2021-06-09
Spinal surgery implant kit recalled for inadequate sterilization
Zavation is recalling ZVplasty 10G spinal implant kits that may not have been properly sterilized. The affected devices were distributed nationwide and may pose infection risk if implanted.
Product
ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1696-2021·2021-06-09
K2M Cascadia AN Interbody Lumbar Implants recalled for mislabeled dimensions
K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants (Lot NCMT-4437923) due to product labeling that references incorrect length or height dimensions. Seven units were distributed to the US and internationally.
Product
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1724-2021·2021-06-09
Zavation Surgical Trocars Recalled Due to Sterilization Concerns
Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.
Product
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2021·2021-06-09
Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization
Zavation is recalling its 10G Single Cement Delivery Kit used in spinal procedures because products distributed as sterile may not have been adequately sterilized. This is an FDA Class II recall.
Product
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1709-2021·2021-06-09
ZVplasty Unipedicular Cement Delivery Cannula Kit May Not Be Adequately Sterilized
Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.
Product
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1704-2021·2021-06-09
Zavation ZVplasty Direct Access Diamond Tip Trocar may not be sterile
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocar (REF VCF-1023) distributed nationwide because products marketed as sterile may not have been adequately sterilized. The device is used in orthopedic and spinal procedures.
Product
ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1685-2021·2021-06-09
Multitom RAX imaging system software addresses beam alignment and dose calculation issues
Siemens is recalling Multitom RAX imaging systems (software version VF10) due to rare software issues affecting beam alignment and radiation dose calculations.
Product
Multitom RAX with software version VF10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1771-2021·2021-06-09
MiniMed 780G Insulin Pump Software Fault Risks Overdose
A software design flaw in the MiniMed 780G Insulin Pump can cause insulin over-delivery. If users deliver an additional bolus without knowing their active insulin level, they risk receiving too much insulin.
Product
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-18
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1692-2021·2021-06-09
Draeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects
Draeger Medical is recalling Babylog VN600 ventilators due to three software issues: unexpected unit restarts, incorrect oxygen-level alarms, and failure of the automated weaning protocol. These defects could affect patient care and safety.
Product
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Category
Medical Device
Distribution
Distributed nationwide

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13801–13825 of 13836