Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Wright Medical Technology, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Medical Devices·1 affected·Sep 30, 2022
High RiskFDA
Beaver Visitec International, Inc.
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot,...
Medical Devices·150 affected·Sep 30, 2022
High RiskFDA
Teleflex Llc
Pilling Wecksorb Cylindrical Sponges
Medical Devices·1,000 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
Medical Devices·409,738 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
Medical Devices·414,194 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
Medical Devices·129,412 affected·Sep 28, 2022
High RiskFDA
X-nav Technologies, Llc
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P01...
Medical Devices·102 affected·Sep 28, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
Medical Devices·499,997 affected·Sep 28, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Medical Devices·318 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
Medical Devices·16 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
Medical Devices·451 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
Medical Devices·265 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
Medical Devices·1,143 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
Medical Devices·483 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
Medical Devices·493 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
Medical Devices·334 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
Medical Devices·319 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
Medical Devices·510 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
Medical Devices·259 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
Medical Devices·537 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
Medical Devices·1,132 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
Medical Devices·308 affected·Sep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
Medical Devices·50 affected·Sep 26, 2022
RecallFDA
Lumiradx
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls a...
Medical Devices·83 affected·Sep 23, 2022
High RiskFDA
Microvention Inc.
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Medical Devices·2,018 affected·Sep 21, 2022
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision Syst...
Medical Devices·162 affected·Sep 20, 2022
High RiskFDA
Fresenius Kabi Usa, Llc
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Medical Devices·3 affected·Sep 16, 2022
High RiskFDA
Olympus Corporation Of The Americas
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Medical Devices·4,184 affected·Sep 16, 2022
High RiskFDA
Baxter Healthcare Corporation
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Medical Devices·29,764 affected·Sep 14, 2022
High RiskFDA
Arrow International Inc.
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For periphe...
Medical Devices·18 affected·Sep 14, 2022
High RiskFDA
Avanos Medical, Inc.
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRO...
Medical Devices·1,378 affected·Sep 14, 2022
High RiskFDA
Baxter Healthcare Corporation
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuou...
Medical Devices·1,068,560 affected·Sep 14, 2022
High RiskFDA
Baxter Healthcare Corporation
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal rep...
Medical Devices·524,376 affected·Sep 14, 2022
High RiskFDA
Thor Photomedicine Ltd
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Medical Devices·26 affected·Sep 13, 2022
High RiskFDA
Thor Photomedicine Ltd
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Medical Devices·19 affected·Sep 13, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
Medical Devices·900 affected·Sep 9, 2022
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Medical Devices·4 affected·Sep 8, 2022
High RiskFDA
Roche Molecular Systems, Inc.
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in l...
Medical Devices·179 affected·Sep 8, 2022
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Medical Devices·18 affected·Sep 7, 2022
High RiskFDA
Balt Usa, Llc
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Medical Devices·41 affected·Sep 7, 2022
CriticalFDA
Philips Respironics, Inc.
Wisp and Wisp Youth Nasal Mask
Medical Devices·6,237,558 affected·Sep 6, 2022
CriticalFDA
Philips Respironics, Inc.
DreamWisp Nasal Mask with Over the Nose Cushion
Medical Devices·930,813 affected·Sep 6, 2022
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Amara View Minimal Contact Full-Face Mask
Medical Devices·5,661,639 affected·Sep 6, 2022
High RiskFDA
Philips North America Llc
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Medical Devices·115 affected·Sep 6, 2022
RecallFDA
Baxter Healthcare Corporation
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starlin...
Medical Devices·9,671 affected·Sep 2, 2022
High RiskFDA
B Braun Medical Inc
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Medical Devices·94,000 affected·Sep 1, 2022
High RiskFDA
Medline Industries, Lp - Northfield
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Medical Devices·1,760 affected·Sep 1, 2022
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Medical Devices·53,624 affected·Sep 1, 2022