Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code...
Medical Devices·987,911 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and fem...
Medical Devices·15,546 affected·Aug 6, 2025
CriticalFDA
Olympus Corporation Of The Americas
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of fou...
Medical Devices·104,508 affected·Aug 6, 2025
High RiskFDA
Seaspine Orthopedics Corporation
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Medical Devices·74 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Medical Devices·265,500 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code...
Medical Devices·211,750 affected·Aug 6, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Medical Devices·458 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active L...
Medical Devices·15,441 affected·Aug 5, 2025
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18...
Medical Devices·810 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural ...
Medical Devices·111,492 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Descriptio...
Medical Devices·994 affected·Aug 5, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5....
Medical Devices·1,369 affected·Aug 5, 2025
High RiskFDA
Wasatch Photonics
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER...
Medical Devices·192 affected·Aug 4, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Medical Devices·10,101 affected·Aug 4, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Medical Devices·57 affected·Aug 4, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Medical Devices·43,922 affected·Aug 4, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i C...
Medical Devices·116 affected·Aug 4, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numb...
Medical Devices·1,861 affected·Aug 1, 2025
High RiskFDA
Lumicell, Inc.
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Mod...
Medical Devices·200 affected·Jul 31, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the ...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Medical Devices·2,320 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all W...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025
High RiskFDA
Vantive Us Healthcare Llc
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Medical Devices·4,772 affected·Jul 28, 2025
High RiskFDA
Vantive Us Healthcare Llc
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Medical Devices·7,432 affected·Jul 28, 2025
High RiskFDA
Zap Surgical Systems
ZAP-X Radiosurgery System, Model: 300150
Medical Devices·17 affected·Jul 25, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Numb...
Medical Devices·2,520 affected·Jul 25, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The No...
Medical Devices·2 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and No...
Medical Devices·55 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The No...
Medical Devices·1 affected·Jul 24, 2025
High RiskFDA
Thor Photomedicine Ltd
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoT...
Medical Devices·80 affected·Jul 24, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG9010...
Medical Devices·4 affected·Jul 23, 2025
CriticalFDA
Tandem Diabetes Care, Inc.
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, R...
Medical Devices·171,750 affected·Jul 21, 2025
High RiskFDA
Diagnostica Stago, Inc.
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA ...
Medical Devices·829,800 affected·Jul 21, 2025
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Medical Devices·144 affected·Jul 16, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNE...
Medical Devices·588 affected·Jul 14, 2025
High RiskFDA
Maquet Gmbh
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software ...
Medical Devices·315 affected·Jul 14, 2025
CriticalFDA
Baxter Healthcare Corporation
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Medical Devices·36,705 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR ...
Medical Devices·781 affected·Jul 14, 2025
High RiskFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion Pump, Product Code 3570009
Medical Devices·6 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2...
Medical Devices·204 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE P...
Medical Devices·1,233 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCO...
Medical Devices·1,094 affected·Jul 14, 2025
High RiskFDA
Remel, Inc
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Medical Devices·1,552 affected·Jul 11, 2025
CriticalFDA
Icu Medical, Inc.
Plum Duo Infusion System, List Number: 400020401
Medical Devices·4,677 affected·Jul 11, 2025