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

8451–8475 of 40056

ModerateFDA (Devices)·Z-0668-2024·2024-01-17
Baxter PERI-GUARD SUPPLE marketing brochure contains inaccurate instructions
Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices because the marketing brochure contains inaccurate content that does not align with the products' actual Instructions for Use.
Product
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM U
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0692-2024·2024-01-17
Videoscope Cleaning Instructions Updated: Reusable Brushes No Longer Compatible
Shirakawa Olympus updated cleaning instructions for VISERA Cysto-Nephro Videoscopes, recommending removal of reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
Product
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0688-2024·2024-01-17
FDA Recalls Rhino-Laryngofiberscope Cleaning Instructions for Brush Compatibility
Shirakawa Olympus is recalling instructions for the Model ENF-XP Rhino-Laryngofiberscope. Reusable cleaning brushes have been removed from the manual cleaning procedure; single-use brushes remain compatible.
Product
Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0662-2024·2024-01-17
Baxter FloSeal Hemostatic Matrix Recalled for Marketing Brochure Inaccuracies
Baxter Healthcare Corporation is recalling Baxter FloSeal Hemostatic Matrix RECOTHROM products because the marketing brochure contains inaccurate information that does not align with the product's official Instructions for Use and Prescribing Information.
Product
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0684-2024·2024-01-17
Model CYF-5 cystonephrofiberscope cleaning instructions updated by Olympus
Shirakawa Olympus has updated cleaning instructions for the Model CYF-5 cystonephrofiberscope, removing reusable cleaning brushes from the manual cleaning protocol while single-use brushes remain compatible.
Product
Model No. CYF-5, Cystonephrofiberscope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0663-2024·2024-01-17
Baxter Flo-Thru Intraluminal Shunt recalled for marketing brochure inaccuracy
Baxter Healthcare is recalling marketing materials for the Flo-Thru Intraluminal Shunt due to inaccurate content that does not match the product's official instructions for use or prescribing information.
Product
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0708-2024·2024-01-17
Robotic Drill Recall: Users Unable to Resolve Disconnection Errors
Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.
Product
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0674-2024·2024-01-17
Cordis MYNXGRIP 5F Vascular Closure Device Carton Labeling Error
Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.
Product
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-0596-2024·2024-01-10
Regard Dressing Change Kit Recalled Due to Defective Irrigation Solution
ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.
Product
Regard Dressing change kit, Item Number 800026006
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0592-2024·2024-01-10
Tracheostomy care kits recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
Product
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0593-2024·2024-01-10
Dressing change tray recalled for sterility assurance failure
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
Product
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0594-2024·2024-01-10
Tracheostomy care sets recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
Product
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0591-2024·2024-01-10
Omnipod 5 insulin pump app bolus calculator decimal point error
The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.
Product
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2024·2024-01-10
FDA Recalls Merit Pursue Microcatheter Due to Sterility Concerns
Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.
Product
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2024·2024-01-10
Microcatheter and Infusion Systems Recalled Due to Sterility Concerns
Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.
Product
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0634-2024·2024-01-10
External Drainage System Collection Bags Recalled for Sterility Assurance Issues
Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.
Product
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0632-2024·2024-01-10
Surgical Knife Crescent Recall Due to Incorrect Blade Angle
Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.
Product
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0627-2024·2024-01-10
Merit Maestro Microcatheter Sterility Recall, 717 Units Distributed Worldwide
Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.
Product
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0631-2024·2024-01-10
Covidien Valleylab FT10 Energy Platform software issue causes inoperability
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.
Product
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2024·2024-01-10
Spinal fixation screws recalled due to incorrect size laser marking
Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.
Product
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0633-2024·2024-01-10
Xstar Kojo slit knife recalled for incorrect blade orientation
One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.
Product
Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0635-2024·2024-01-10
EDS 3 CSF External Drainage System recalled for incomplete sterility testing
Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.
Product
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0623-2024·2024-01-10
Medtronic Protege GPS Stent System Recalled for Packaging Seal Defects
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.
Product
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0638-2024·2024-01-10
Philips Trilogy Evo respiratory devices recalled for missing contraindication statement
Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.
Product
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA21
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2024·2024-01-10
Impella Connect medical device software portal disables unevaluated features
Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.
Product
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Category
Medical Device
Distribution
Distributed nationwide

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8451–8475 of 40056