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

13151–13175 of 13802

HighFDA (Devices)·Z-2341-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Release Helium Gas
Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.
Product
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2021·2021-09-01
Accu-Chek Performa Test Strips Recalled Due to Defective Packaging
Roche Diabetes Care is recalling Accu-Chek Performa test strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to inappropriate diabetes treatment decisions.
Product
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2021·2021-09-01
MRI System Pressure Valve Installation Error Poses Helium Release Risk
A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.
Product
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2351-2021·2021-09-01
Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings
Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.
Product
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2339-2021·2021-09-01
OASIS MRI table pads recalled for missing latex allergen labeling
Hitachi Healthcare Americas has recalled OASIS MRI System table pads due to missing labels and user manual notification about dry natural rubber content. The missing notification violates federal labeling requirements for this latex allergen.
Product
OASIS MRI System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2336-2021·2021-09-01
KeyPrint Soft Dental Resin Recalled for Incorrect European Labeling
Straumann USA LLC recalled KeyPrint Soft resin bottles (Lot KJ2858) that were distributed with European product labels instead of US-compliant labeling. Dental professionals should verify if they received affected units.
Product
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2334-2021·2021-09-01
FDA Recalls Reprocessed IVUS Catheters Due to Reprocessing Cycle Violation
Northeast Scientific Inc. is recalling 690 reprocessed intravascular ultrasound catheters because they exceed the FDA-approved single reprocessing cycle limit. Devices were distributed nationwide across ten states.
Product
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2333-2021·2021-09-01
BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination
This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.
Product
BD" Mouse IgG2a Isotype Control APC X39 ASR
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2244-2021·2021-08-25
Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
Product
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2300-2021·2021-08-25
IV Catheters Recalled Due to Possible Missing Sterility
Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.
Product
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2021·2021-08-25
FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues
Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk to patients.
Product
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2313-2021·2021-08-25
NEO-KATH Caudal Catheter Set Recalled Due to Stylet Protrusion Risk
Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.
Product
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Category
Medical Device
Distribution
8 states
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
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-2325-2021·2021-08-25
Evexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance
Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.
Product
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2310-2021·2021-08-25
OPTI SARS-CoV-2 RT-PCR Test Kits Recalled for False Positive Results
OPTI Medical Systems is recalling COVID-19 test kits due to a precipitation issue that may cause false positive results in 5-10% of affected vials. No illnesses have been reported.
Product
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2301-2021·2021-08-25
NEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure
NEO DELTA Self Safe T IV catheters may lack sterility due to sterilization problems. The FDA is recalling 20,000 units distributed in Florida and Minnesota.
Product
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
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-2326-2021·2021-08-25
Surgical stapler mislabeled with incorrect device size
Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.
Product
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2302-2021·2021-08-25
I.V. Catheter Recall Due to Sterilization Failures
Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.
Product
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2021·2021-08-25
Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall
W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.
Product
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2303-2021·2021-08-25
IV Catheters Recalled by FDA for Sterilization Defects
Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 units distributed in Florida and Minnesota.
Product
NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
Category
Medical Device
Distribution
Distributed nationwide
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-2289-2021·2021-08-25
Trilogy EV300 Ventilator Recalled for Software-Related Pressure Calibration Issues
Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.
Product
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2316-2021·2021-08-25
CT system software error recommends excessive contrast volume
A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.
Product
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide

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13151–13175 of 13802