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

25726–25750 of 26126

HighFDA (Devices)·Z-1789-2021·2021-06-09
Terumo HX2 and TCM Temperature Management Systems Recalled for Cleaning Protocol Issues
Terumo recalled the HX2 and TCM temperature management systems used in cardiac surgery due to inability to validate an updated cleaning protocol. Users should discontinue use and properly dispose of affected devices.
Product
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1780-2021·2021-06-09
Tranberg MR Cannula: Inadequate Sterilization May Compromise Safety
CLINICAL LASERTHERMIA SYSTEMS AB is recalling the Tranberg MR Cannula due to potentially inadequate sterilization of certain lots. Affected units were distributed to medical facilities in the US and internationally.
Product
Tranberg MR Cannula, REF: 4013-05, 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-1698-2021·2021-06-09
T25 Cannulated Screwdrivers May Break During Surgical Procedures
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits may break at the driver tip during use, extending surgery time and requiring additional imaging to identify fragments.
Product
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1779-2021·2021-06-09
Oral surgery scrapers recalled due to possible inadequate sterilization
Meta C.G.M. Spa recalls 27 units of REF 4890 SMARTSCRAPER oral surgery instruments distributed in Texas and Florida. The sterile-labeled devices may not have been adequately sterilized.
Product
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
Category
Medical Device
Distribution
0 states
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-1752-2021·2021-06-09
InterV Kyphoplasty Spinal Devices Recalled for Inadequate Sterilization
Zavation's InterV 10G FLEX Kyphoplasty spinal devices are recalled because they may not have been adequately sterilized. The recall affects 178 units distributed nationwide.
Product
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1690-2021·2021-06-09
Critical care ventilators recalled for software defects affecting alarm and operation
Draeger Medical is recalling critical care ventilators due to software defects that can cause the device to restart, display incorrect oxygen alarms, and suspend weaning protocols. No patient injuries have been reported.
Product
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
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-1760-2021·2021-06-09
ZVplasty System spinal implant recalled due to inadequate sterilization
Zavation is recalling ZVplasty System 15mm orthopedic spinal implants because products distributed as sterile may not have been adequately sterilized. Affected lot numbers were distributed nationwide.
Product
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2021·2021-06-09
Zavation CEMIX Orthopedic Cement Mixing System Sterilization Recall
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
Product
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. 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-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-1735-2021·2021-06-09
Orthopedic Cement Delivery Kits Recalled Due to Sterilization Concerns
Zavation's 10G cement delivery kits for spinal procedures may not be adequately sterilized despite being marketed as sterile. Patients and healthcare providers should contact Zavation regarding potentially affected units.
Product
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0641-2021·2021-06-09
Clio Greek Yogurt Strawberry Minis Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Greek Yogurt Bar Strawberry Minis due to the possible presence of metal fragments in the product. The affected pouches were distributed nationwide.
Product
Clio Greek Yogurt Bar Strawberry Minis 6.2oz pouch x 6 pouches per case) UPC Code:854021008084
Category
Food
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-1702-2021·2021-06-09
ZVplasty Drill units may not have been adequately sterilized
Zavation recalled ZVplasty Drill units (REF VCF-1006, batch 19113036) distributed nationwide. The 38 affected units may not have been adequately sterilized, creating a risk of infection.
Product
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1707-2021·2021-06-09
ZVplasty Surgical Bone Access Kit Recalled for Inadequate Sterilization
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Affected lot numbers 19113043 and 20041107 were distributed nationwide.
Product
ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1774-2021·2021-06-09
Philips BRILLIANCE VOLUME CT System cooling unit may eject from gantry
A cooling unit in the Philips BRILLIANCE VOLUME computed tomography system may unexpectedly eject from the gantry, posing a risk of injury. Two affected units are being recalled.
Product
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
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-1708-2021·2021-06-09
ZVplasty Bone Access Kit Recalled for Inadequate Sterilization
Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.
Product
ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0634-2021·2021-06-09
Clio No Added Sugar Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio No Added Sugar Yogurt Bars (Mixed Berry/Peach, 50g) due to possible metal fragments in the product. Approximately 1,880 units were distributed nationwide.
Product
Clio No Added Sugar Yogurt Bar Mixed Berry / Peach 50g x 16 (12pc tray). UPC Code: 854021008220
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1689-2021·2021-06-09
Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk
Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.
Product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1715-2021·2021-06-09
Orthopedic spinal surgical device may lack adequate sterilization
Zavation is recalling its 10G DIRECT SINGLE - ACCESS device used in spinal surgery. Products distributed as sterile may not have been adequately sterilized.
Product
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1756-2021·2021-06-09
OsteoFlex Bone Cement Recalled Due to Inadequate Sterilization
Zavation's OsteoFlex bone cement distributed nationwide may not have been adequately sterilized. Patients who received this sterile surgical product in orthopedic or spinal procedures should contact their healthcare provider.
Product
OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide

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25726–25750 of 26126