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.
- Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Dr…
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: i…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodi…
FDA Device · Class II · 2020-10-07 · Zeus Scientific - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150
FDA Device · Class II · 2020-10-07 · Ameditech - Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers…
FDA Device · Class II · 2020-10-07 · Covidien - First Check 2 Panel Drug Cup: (THC/COC)
FDA Device · Class II · 2020-10-07 · Ameditech - AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following po…
FDA Device · Class II · 2020-10-07 · Esaote S P A - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product U…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Drug Screen Dipstick Tes…
FDA Device · Class II · 2020-10-07 · Ameditech - AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following po…
FDA Device · Class II · 2020-10-07 · Esaote S P A - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Produc…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product Number: SV9911G, UDI: 20884521149776 - Product Usag…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - ProxiDiagnost N90
FDA Device · Class II · 2020-10-07 · Philips North America - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicate…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50…
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - Produ…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - Produc…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - Product…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20884521150925 - Product…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - Product Usage: indicate…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicat…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicate…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Produ…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Product…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Produc…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Dete…
FDA Device · Class II · 2020-10-07 · Ameditech - VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process bl…
FDA Device · Class II · 2020-10-07 · Greiner Bio One North America - Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/M…
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Pr…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated for use…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers…
FDA Device · Class II · 2020-10-07 · Covidien - Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX…
FDA Device · Class II · 2020-10-07 · Ameditech - First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC)
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated for…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC…
FDA Device · Class II · 2020-10-07 · Ameditech - UIBC
FDA Device · Class II · 2020-10-07 · Beckman Coulter - CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc
FDA Device · Class II · 2020-10-07 · Ameditech - Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The E…
FDA Device · Class II · 2020-10-07 · Covidien - ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PS…
FDA Device · Class II · 2020-10-07 · Ameditech - ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC…
FDA Device · Class II · 2020-10-07 · Ameditech - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - Product Usag…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers…
FDA Device · Class II · 2020-10-07 · Covidien - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicate…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers…
FDA Device · Class II · 2020-10-07 · Covidien - Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm
FDA Device · Class II · 2020-10-07 · Exactech - Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pati…
FDA Device · Class II · 2020-10-07 · Stryker Medical Division - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - Produ…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm
FDA Device · Class II · 2020-10-07 · Exactech - Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/…
FDA Device · Class II · 2020-10-07 · Ameditech - Pacific Xtreme (PTCA Balloon Dilation Catheter)
FDA Device · Class II · 2020-10-07 · Ev3 - First Check 1 Panel Drug Cup: (THC)
FDA Device · Class II · 2020-10-07 · Ameditech - KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus
FDA Device · Class II · 2020-10-07 · Cardinal Health 200 - 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit
FDA Device · Class II · 2020-10-07 · North American Rescue - JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces
FDA Device · Class II · 2020-10-07 · Office Depot - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - Product Us…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
FDA Device · Class II · 2020-10-07 · Encore Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicate…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - Produ…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC…
FDA Device · Class II · 2020-10-07 · Ameditech - First Check 14 Panel Drug Cup: (BMC style)
FDA Device · Class II · 2020-10-07 · Ameditech - Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027…
FDA Device · Class II · 2020-10-07 · Siemens Medical Solutions Usa - RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
FDA Device · Class II · 2020-10-07 · Encore Medical - Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - Product Usage…
FDA Device · Class II · 2020-10-07 · Riverpoint Medical - EVOLVE STEM 8.5MM Model # 496S085
FDA Device · Class II · 2020-09-30 · Wright Medical Technology - NM/CT 860, SPECT/CT
FDA Device · Class II · 2020-09-30 · Ge Healthcare - PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256
FDA Device · Class I · 2020-09-30 · Microport Orthopedics - Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophy…
FDA Device · Class II · 2020-09-30 · Irvine Biomedical A St Jude Medical - Discovery 670 DR Model # H3100BT
FDA Device · Class II · 2020-09-30 · Ge Healthcare - Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a compo…
FDA Device · Class II · 2020-09-30 · Sorin Group Italia S R L - Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is…
FDA Device · Class II · 2020-09-30 · Sorin Group Italia S R L - Speed Stitch Needle Cassette
FDA Device · Class II · 2020-09-30 · Arthrocare - NM/CT 850 Model Number: H3907AD
FDA Device · Class II · 2020-09-30 · Ge Healthcare - NM/CT 870 CZT Model # H3906CW
FDA Device · Class II · 2020-09-30 · Ge Healthcare - Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
FDA Device · Class II · 2020-09-30 · Hologic - Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is…
FDA Device · Class II · 2020-09-30 · Sorin Group Italia S R L - Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Device · Class II · 2020-09-30 · Arthrocare - CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the trea…
FDA Device · Class III · 2020-09-30 · Orasure Technologies - NM/CT 870 DR Model # H3100AS
FDA Device · Class II · 2020-09-30 · Ge Healthcare - Discovery NM670 Pro Model # H3100XB
FDA Device · Class II · 2020-09-30 · Ge Healthcare - Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosu…
FDA Device · Class III · 2020-09-30 · Orasure Technologies - NM 830 Model # H3910AC
FDA Device · Class II · 2020-09-30 · Ge Healthcare - Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for…
FDA Device · Class III · 2020-09-30 · Orasure Technologies - Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is…
FDA Device · Class II · 2020-09-30 · Sorin Group Italia S R L - PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264
FDA Device · Class I · 2020-09-30 · Microport Orthopedics - Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophy…
FDA Device · Class II · 2020-09-30 · Irvine Biomedical A St Jude Medical - Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced appl…
FDA Device · Class II · 2020-09-30 · Siemens Medical Solutions Usa - Central Line Dressing Change Tray
FDA Device · Class II · 2020-09-30 · Medline Industries - BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qu…
FDA Device · Class II · 2020-09-30 · Bio Rad Laboratories - Discovery NM 630 Model # H3101RH
FDA Device · Class II · 2020-09-30 · Ge Healthcare - PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the re…
FDA Device · Class III · 2020-09-30 · Dna Genotek - Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is…
FDA Device · Class II · 2020-09-30 · Sorin Group Italia S R L - DxA 5000
FDA Device · Class II · 2020-09-30 · Beckman Coulter Biomedical - BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570
FDA Device · Class II · 2020-09-30 · Beckman Coulter - Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10
FDA Device · Class II · 2020-09-23 · Inpeco - Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terum…
FDA Device · Class II · 2020-09-23 · Terumo Cardiovascular Systems - FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10
FDA Device · Class II · 2020-09-23 · Inpeco - AVANOS MIC-KEY SF Gastrostomy Feeding Tube
FDA Device · Class II · 2020-09-23 · Avanos Medical - Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended…
FDA Device · Class II · 2020-09-23 · Tosoh Bioscience
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)