FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-28
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-22
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 49 mm Number: 00-8065-946-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support t…
FDA Device · Class II · 2020-11-11 · Ge Healthcare - Flow Sensor Service Part, Catalog 2087640-001-S
FDA Device · Class II · 2020-11-11 · Ge Healthcare - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-2…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 47 mm Item Number: 00-8065-544-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 61 mm Number: 00-8065-958-32
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of…
FDA Device · Class II · 2020-11-11 · Microbiologics - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 45mm Item Number: 00-8065-542-2…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-2…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MD…
FDA Device · Class II · 2020-11-04 · Rti Surgical Dba Pioneer Surgical Technology - Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and…
FDA Device · Class II · 2020-11-04 · Ge Healthcare - Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used i…
FDA Device · Class II · 2020-11-04 · Philips North America - 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
FDA Device · Class II · 2020-11-04 · Pentax - The Quidel Triage BNP Calibrators
FDA Device · Class II · 2020-11-04 · Medline Industries - Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab
FDA Device · Class II · 2020-11-04 · Microbiologics - Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890
FDA Device · Class II · 2020-11-04 · Boston Scientific - Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table a…
FDA Device · Class II · 2020-11-04 · Siemens Medical Solutions Usa - Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab
FDA Device · Class II · 2020-11-04 · Microbiologics - GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
FDA Device · Class II · 2020-11-04 · W L Gore And Associates - GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
FDA Device · Class II · 2020-11-04 · W L Gore And Associates - Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used…
FDA Device · Class II · 2020-11-04 · Philips North America - 5.5MM Arthrogarde Hip Access Cannula
FDA Device · Class II · 2020-11-04 · Smith And Nephew - Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab
FDA Device · Class II · 2020-11-04 · Microbiologics - Merge LIS
FDA Device · Class II · 2020-11-04 · Merge Healthcare - Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only
FDA Device · Class II · 2020-11-04 · Exactech - CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot…
FDA Device · Class II · 2020-11-04 · Cme America - Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blo…
FDA Device · Class II · 2020-11-04 · Becton Dickinson And - Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2…
FDA Device · Class II · 2020-11-04 · Battelle Memorial Institute - Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, bl…
FDA Device · Class II · 2020-11-04 · Becton Dickinson And - Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TA…
FDA Device · Class II · 2020-11-04 · Rti Surgical Dba Pioneer Surgical Technology - Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a t…
FDA Device · Class II · 2020-11-04 · Boston Scientific - Instructions For Use document of the GPS Trackers
FDA Device · Class II · 2020-11-04 · Blue Ortho - Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only
FDA Device · Class II · 2020-11-04 · Exactech - da Vinci Surgical System, IS 4000
FDA Device · Class II · 2020-11-04 · Intuitive Surgical - LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
FDA Device · Class II · 2020-11-04 · Thread Counsel - 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal)
FDA Device · Class II · 2020-11-04 · Pentax - 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring),…
FDA Device · Class II · 2020-10-28 · Icu Medical - Langston Dual Lumen Catheter
FDA Device · Class I · 2020-10-28 · Vascular Solutions - 7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock
FDA Device · Class II · 2020-10-28 · Icu Medical - NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Langston Dual Lumen Catheter
FDA Device · Class I · 2020-10-28 · Vascular Solutions - 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per c…
FDA Device · Class II · 2020-10-28 · Icu Medical - System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution,…
FDA Device · Class II · 2020-10-28 · Ge Healthcare - 5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
FDA Device · Class II · 2020-10-28 · Smith And Nephew - TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
FDA Device · Class II · 2020-10-28 · Smith And Nephew - Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)006…
FDA Device · Class II · 2020-10-28 · Siemens Healthcare Diagnostics - 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 5…
FDA Device · Class II · 2020-10-28 · Icu Medical - NanoClave Stopcock w/NanoClave
FDA Device · Class II · 2020-10-28 · Icu Medical - OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the S…
FDA Device · Class II · 2020-10-28 · Quidel - 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating L…
FDA Device · Class II · 2020-10-28 · Icu Medical - 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor,…
FDA Device · Class II · 2020-10-28 · Olympus - Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for…
FDA Device · Class II · 2020-10-28 · Bien Air Surgery - 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES
FDA Device · Class II · 2020-10-28 · Icu Medical - Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM)
FDA Device · Class I · 2020-10-28 · Stryker Neurovascular - 165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
FDA Device · Class II · 2020-10-28 · Smith And Nephew - System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution,…
FDA Device · Class II · 2020-10-28 · Ge Healthcare - 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
FDA Device · Class II · 2020-10-28 · Smith And Nephew - SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthca…
FDA Device · Class II · 2020-10-28 · Sobel Westex - SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
FDA Device · Class II · 2020-10-28 · Smith And Nephew - 9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
FDA Device · Class II · 2020-10-28 · Smith And Nephew - TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
FDA Device · Class II · 2020-10-28 · Smith And Nephew - MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of…
FDA Device · Class III · 2020-10-28 · Invivo - Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
FDA Device · Class II · 2020-10-28 · Smith And Nephew - BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to…
FDA Device · Class II · 2020-10-28 · Becton Dickinson And - 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext
FDA Device · Class II · 2020-10-28 · Icu Medical - 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 E…
FDA Device · Class II · 2020-10-28 · Icu Medical - Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of al…
FDA Device · Class II · 2020-10-28 · Siemens Healthcare Diagnostics - 5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer
FDA Device · Class II · 2020-10-28 · Icu Medical - OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
FDA Device · Class II · 2020-10-28 · Smith And Nephew - Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - Spectrum IQ Infusion System with Dose IQ Safety Software
FDA Device · Class I · 2020-10-28 · Baxter Healthcare - 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock
FDA Device · Class II · 2020-10-28 · Icu Medical - 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical - 11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case
FDA Device · Class II · 2020-10-28 · Icu Medical
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)