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

13226–13250 of 13837

HighFDA (Devices)·Z-2319-2021·2021-08-25
RUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation
Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes because the cuff can inflate while the pilot balloon remains flat, potentially affecting airway pressure monitoring.
Product
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2021·2021-08-25
FDA Recalls DELTAVEN Safety I.V. Catheters Due to Sterilization Defect
Delta Med SpA recalls 30,900 DELTAVEN Safety I.V. Catheters in Florida and Minnesota due to potential sterilization failures that could compromise device sterility.
Product
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2324-2021·2021-08-25
CIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance
The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.
Product
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2287-2021·2021-08-25
Trilogy Evo Ventilator Software Defect May Cause Pressure Increase
Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.
Product
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2309-2021·2021-08-25
Dual Balloon Angioplasty Catheter Recalled for Balloon Deflation Difficulty
Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.
Product
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2305-2021·2021-08-25
FDA Recalls WOLF-PAK IV Catheters Due to Sterilization Problems
Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization defects affecting approximately 40,000 units in Florida and Minnesota.
Product
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2288-2021·2021-08-25
Trilogy Evo O2 Ventilator Software Issues Affecting Pressure Delivery
Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.
Product
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2021·2021-08-25
Triathlon orthopaedic implant baseplate recalled for assembly defect
Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.
Product
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2021·2021-08-25
RUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication
Teleflex recalls RUSCH endotracheal tubes because the cuff can be inflated while the pilot balloon remains flat, preventing proper monitoring of cuff pressure.
Product
RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2320-2021·2021-08-25
RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response
Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.
Product
RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2314-2021·2021-08-25
Brilliance iCT Computed Tomography Systems Recalled for Contrast Dosing Error
Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.
Product
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2196-2021·2021-08-18
Heartware HVAD ventricular assist device recalled due to mortality risk
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
Product
HeartWare HVAD Outflow Graft, REF MCS1725OG
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2194-2021·2021-08-18
HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.
Product
HeartWare HVAD Implant Kit, REF 1104JP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2195-2021·2021-08-18
HeartWare HVAD Implant Kit Recalled Over Higher Mortality Rates
Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.
Product
HeartWare HVAD Implant Kit, REF MCS1705PU
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2190-2021·2021-08-18
HeartWare HVAD heart pump implants recalled for neurological events and mortality
Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.
Product
HeartWare HVAD Pump Implant Kit, REF 1125
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2197-2021·2021-08-18
Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures
Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.
Product
HeartWare HVAD Pump Accessories, REF MCS1753AK
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2193-2021·2021-08-18
HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns
Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.
Product
HeartWare HVAD Driveline Extension Cable, REF 100US
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2191-2021·2021-08-18
HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Product
HeartWare HVAD Pump Implant Kit, REF 1153
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2188-2021·2021-08-18
FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.
Product
HeartWare HVAD Pump Implant Kit, REF 1103
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2192-2021·2021-08-18
HeartWare HVAD System Recalled Due to Higher Mortality Rates
Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.
Product
HeartWare HVAD Driveline Extension Cable, REF 100
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2165-2021·2021-08-18
Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
Product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2189-2021·2021-08-18
Heart Pump Device Recalled for Increased Mortality and Device Failure
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
Product
HeartWare HVAD Pump Implant Kit, REF 1104
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2204-2021·2021-08-18
Infusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2110-2021·2021-08-18
Spectrum IQ Infusion System Recalled for Connectivity Errors
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
Product
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2212-2021·2021-08-18
Medical device designed for healthcare professionals distributed to untrained home users
Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.
Product
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Category
Medical Device
Distribution
Distributed nationwide

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13226–13250 of 13837