Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 201 of 548
FDA Devices Moderate Oct 28, 2020
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(1…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. U…
ICU Medical, Inc.
FDA Devices Moderate Oct 28, 2020
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bo…
Bien-Air Surgery Sa
FDA Devices Critical Oct 28, 2020
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind ba…
Medtronic Vascular
FDA Devices Moderate Oct 28, 2020
TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
Smith & Nephew, Inc.
FDA Devices Moderate Oct 28, 2020
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
Smith & Nephew, Inc.
CPSC Moderate Oct 28, 2020
Schneider Electric Recalls Surgeloc™ Surge Protection Devices Due to Fire Hazard
Schneider Electric Systems USA, Inc., of Foxboro, Mass.
FDA Food Moderate Oct 21, 2020
Lucky Spoon Bakery Gluten Free Fall Frost Pumpkin Cupcake, 8.0 oz. plastic clam shell containing 4 cupcakes, UPC 8-50489-00320-3, P.O. Box 2954 Salt …
Lucky Spoon Bakery, LLC
FDA Devices Moderate Oct 21, 2020
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used …
Getinge Group Logistics America, LLC
FDA Devices Moderate Oct 21, 2020
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human s…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 21, 2020
SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended…
Handicare AB
FDA Devices Moderate Oct 21, 2020
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
FDA Devices Low Oct 21, 2020
Albumin Gen.2, Catalog 05166861190
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Oct 21, 2020
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 21, 2020
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. …
Biomet, Inc.
FDA Devices Moderate Oct 21, 2020
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho …
Mizuho OSI
FDA Devices Moderate Oct 21, 2020
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surge…
Alcon Research, LLC
FDA Devices Moderate Oct 21, 2020
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacu…
Genicon, Inc.
FDA Devices Moderate Oct 21, 2020
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended t…
Biomet, Inc.
FDA Devices Low Oct 21, 2020
Tina-quant Complement C4 ver.2, Catalog 05991994190
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Oct 21, 2020
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07…
Gentian AS
FDA Devices Moderate Oct 21, 2020
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial co…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Oct 14, 2020
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone T…
Nuvasive Specialized Orthopedics Inc
FDA Devices Moderate Oct 14, 2020
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an…
Brainlab AG
FDA Devices Moderate Oct 14, 2020
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Oct 14, 2020
DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibi…
Encore Medical, LP
FDA Devices Moderate Oct 14, 2020
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Biomet, Inc.
FDA Devices Moderate Oct 14, 2020
Quick Release Gait Belt, 60
Medline Industries Inc
FDA Devices Moderate Oct 14, 2020
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SK…
Skytron, Div. The KMW Group, Inc
FDA Devices Moderate Oct 14, 2020
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Biomet 3i, LLC
FDA Devices Moderate Oct 14, 2020
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Biomet, Inc.
FDA Devices Moderate Oct 14, 2020
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of an…
Medline Industries Inc
FDA Devices Moderate Oct 14, 2020
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combi…
Medline Industries Inc
FDA Devices Moderate Oct 14, 2020
Biomet Regenerex Primary Taper Cap Item Number 141269
Biomet, Inc.
FDA Devices Moderate Oct 14, 2020
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combi…
Medline Industries Inc
FDA Devices Moderate Oct 14, 2020
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any co…
Medline Industries Inc
FDA Devices Moderate Oct 14, 2020
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Biomet 3i, LLC
FDA Devices Moderate Oct 14, 2020
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transl…
Bard Peripheral Vascular Inc
FDA Devices Moderate Oct 14, 2020
CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
Biomet 3i, LLC
FDA Devices Low Oct 14, 2020
Neoprobe GDS Control Unit, Model Number NPCU3
Devicor Medical Products Inc
FDA Devices Moderate Oct 14, 2020
MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes t…
Ansell Healthcare Products LLC
FDA Devices Moderate Oct 14, 2020
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular diseas…
Ra Medical Systems, Inc.
FDA Devices Moderate Oct 14, 2020
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Biomet 3i, LLC
FDA Devices Moderate Oct 14, 2020
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any co…
Medline Industries Inc
FDA Devices Moderate Oct 14, 2020
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combin…
Medline Industries Inc