Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 218 of 548
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is used to gain a…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Becton Dickinson & Company
FDA Devices Moderate May 20, 2020
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or …
ICU Medical, Inc.
FDA Devices Moderate May 20, 2020
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to lo…
Cardiac Assist, Inc
FDA Devices Moderate May 20, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing …
BD SWITZERLAND SARL
FDA Devices Moderate May 20, 2020
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a36…
Inpeco S.A.
FDA Devices Moderate May 20, 2020
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various…
Merit Medical Systems, Inc.
FDA Devices Moderate May 20, 2020
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory sy…
Cardiac Assist, Inc
FDA Devices Moderate May 20, 2020
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interven…
Philips North America, LLC
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain ac…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The …
Encore Medical, LP
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to g…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simult…
Covidien Llc
FDA Devices Low May 20, 2020
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Karl Storz Endoscopy
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and…
Covidien Llc
FDA Devices Moderate May 20, 2020
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Produ…
Becton, Dickinson and Company, BD Biosciences
FDA Devices Moderate May 13, 2020
Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and…
Inpeco S.A.
FDA Devices Critical May 13, 2020
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04…
Applied Medical Resources Corp
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair o…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair o…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair o…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF …
ICU Medical, Inc.
FDA Devices Moderate May 13, 2020
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage…
Nobel Biocare Usa Llc
FDA Devices Moderate May 13, 2020
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
ICU Medical, Inc.
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair …
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilize…
Ivoclar Vivadent AG
FDA Devices Moderate May 13, 2020
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replaceme…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized …
Ivoclar Vivadent AG
FDA Devices Moderate May 13, 2020
REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
ICU Medical, Inc.
FDA Devices Moderate May 13, 2020
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to b…
Intuitive Surgical, Inc.
FDA Devices Moderate May 13, 2020
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Ortho Development Corporation
FDA Devices Moderate May 13, 2020
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Philips North America, LLC
FDA Devices Moderate May 13, 2020
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-1…
Gentell, Inc
FDA Devices Moderate May 13, 2020
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product …
Nobel Biocare Usa Llc
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or …
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm …
Medtronic Navigation, Inc.
FDA Devices Moderate May 13, 2020
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage:…
Nobel Biocare Usa Llc
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair o…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair o…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Philips North America, LLC
FDA Devices Moderate May 13, 2020
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-…
Gentell, Inc
FDA Devices Moderate May 13, 2020
REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
ICU Medical, Inc.
FDA Devices Moderate May 13, 2020
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for pa…
CME America, LLC
FDA Devices Moderate May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized…
Ivoclar Vivadent AG
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair o…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf an…
Inpeco S.A.
FDA Devices Moderate May 13, 2020
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if scre…
Nobel Biocare Usa Llc
FDA Devices Moderate May 13, 2020
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Northgate Technologies, Inc.
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair o…
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or …
Maquet Cardiovascular, LLC