FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- ECHELON Oval MRI System
FDA Device · Class II · 2021-09-01 · Hitachi Healthcare Americas - HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desir…
FDA Device · Class II · 2021-09-01 · Ethicon Endo Surgery - Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-01 · Philips North America - OASIS MRI System
FDA Device · Class II · 2021-09-01 · Hitachi Healthcare Americas - BD" Mouse IgG2a Isotype Control APC X39 ASR
FDA Device · Class II · 2021-09-01 · Becton Dickinson And Bd Biosciences - Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 069083…
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
FDA Device · Class II · 2021-08-25 · Philips Respironics - FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
FDA Device · Class II · 2021-08-25 · Ostial - Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2…
FDA Device · Class II · 2021-08-25 · Philips Respironics - Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811)
FDA Device · Class I · 2021-08-25 · Cardinal Health 200 - Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
FDA Device · Class III · 2021-08-25 · Cell Marque - NEO DELTA SELFSAFE PUR T, I.V. Catheter
FDA Device · Class II · 2021-08-25 · Delta Med Spa - EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
FDA Device · Class II · 2021-08-25 · Ortho8 - NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
FDA Device · Class II · 2021-08-25 · Delta Med Spa - Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
FDA Device · Class II · 2021-08-25 · Philips North America - Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following in…
FDA Device · Class II · 2021-08-25 · Coopersurgical - EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Device · Class II · 2021-08-25 · Philips Ultrasound - NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
FDA Device · Class II · 2021-08-25 · Delta Med Spa - 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
FDA Device · Class II · 2021-08-25 · Philips North America - 728332 IQon Spectral CT-Computed Tomography X-ray system
FDA Device · Class II · 2021-08-25 · Philips North America - Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B,…
FDA Device · Class II · 2021-08-25 · Philips Respironics - NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
FDA Device · Class II · 2021-08-25 · Delta Med Spa - DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846…
FDA Device · Class II · 2021-08-25 · Delta Med Spa - Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
FDA Device · Class II · 2021-08-25 · Cytocell - 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
FDA Device · Class II · 2021-08-25 · Philips North America - RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 1700…
FDA Device · Class II · 2021-08-25 · Teleflex Medical Europe - NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
FDA Device · Class II · 2021-08-25 · Delta Med Spa - 728333 Spectral CT 7500 -Computed Tomography X-ray system
FDA Device · Class II · 2021-08-25 · Philips North America - OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
FDA Device · Class II · 2021-08-25 · Opti Medical Systems - RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 11208…
FDA Device · Class II · 2021-08-25 · Teleflex Medical Europe - Trilogy Evo Universal, Product number DS2000X11B
FDA Device · Class II · 2021-08-25 · Philips Respironics - Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference…
FDA Device · Class II · 2021-08-25 · W L Gore And Associates - The Aequalis Pyrocarbon Humeral Heads
FDA Device · Class II · 2021-08-25 · Tornier S - Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
FDA Device · Class II · 2021-08-25 · Howmedica Osteonics - RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065…
FDA Device · Class II · 2021-08-25 · Teleflex Medical Europe - NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
FDA Device · Class II · 2021-08-25 · Epimed International - Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference…
FDA Device · Class II · 2021-08-25 · W L Gore And Associates - ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses
FDA Device · Class II · 2021-08-25 · Ethicon Endo Surgery - WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
FDA Device · Class II · 2021-08-25 · Delta Med Spa - DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f…
FDA Device · Class II · 2021-08-25 · Delta Med Spa - Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection,…
FDA Device · Class II · 2021-08-25 · Olympus - TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
FDA Device · Class II · 2021-08-25 · Boston Scientific - RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 5045…
FDA Device · Class II · 2021-08-25 · Teleflex Medical Europe - NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
FDA Device · Class II · 2021-08-25 · Epimed International - Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic proced…
FDA Device · Class II · 2021-08-25 · Hitachi Healthcare Americas - DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
FDA Device · Class II · 2021-08-25 · Delta Med Spa - CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, La…
FDA Device · Class II · 2021-08-25 · Ortho8 - DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
FDA Device · Class II · 2021-08-25 · Delta Med Spa - TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA Device · Class II · 2021-08-25 · Boston Scientific - NEO DELTA Self Safe, I.V. Catheter REF 3738222
FDA Device · Class II · 2021-08-25 · Delta Med Spa - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
FDA Device · Class II · 2021-08-18 · Biomet - Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020)
FDA Device · Class II · 2021-08-18 · Medline Industries - Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
FDA Device · Class II · 2021-08-18 · Biomet - ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737
FDA Device · Class II · 2021-08-18 · Beckman Coulter - Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single…
FDA Device · Class II · 2021-08-18 · Beckman Coulter - CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge
FDA Device · Class II · 2021-08-18 · Integra Lifesciences - HeartWare HVAD Driveline Extension Cable, REF 100
FDA Device · Class I · 2021-08-18 · Heartware - Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
FDA Device · Class II · 2021-08-18 · Biomet - Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade
FDA Device · Class II · 2021-08-18 · Covidien - Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
FDA Device · Class II · 2021-08-18 · Carl Zeiss Meditec - HeartWare HVAD Pump Implant Kit, REF 1125
FDA Device · Class I · 2021-08-18 · Heartware - Simpleware ScanIP software
FDA Device · Class II · 2021-08-18 · Simpleware Product Group Synopsys Northern Europe - Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
FDA Device · Class II · 2021-08-18 · Biomet - ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
FDA Device · Class II · 2021-08-18 · Beckman Coulter - Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommende…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
FDA Device · Class II · 2021-08-18 · Biomet - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
FDA Device · Class II · 2021-08-18 · Biomet - Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, P…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TI…
FDA Device · Class I · 2021-08-18 · Biomedical Equipment Service Bmes - Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2,…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
FDA Device · Class II · 2021-08-18 · Biomet - HeartWare HVAD Pump Implant Kit, REF 1153
FDA Device · Class I · 2021-08-18 · Heartware - Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO,…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the wo…
FDA Device · Class II · 2021-08-18 · Shent Usa - TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusi…
FDA Device · Class II · 2021-08-18 · Bard Peripheral Vascular - The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.2…
FDA Device · Class II · 2021-08-18 · Dutch Ophthalmic Usa - Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/20…
FDA Device · Class II · 2021-08-18 · Medline Industries - HeartWare HVAD Driveline Extension Cable, REF 100US
FDA Device · Class I · 2021-08-18 · Heartware - Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 0088445046…
FDA Device · Class II · 2021-08-18 · Merit Medical Systems - ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713
FDA Device · Class II · 2021-08-18 · Beckman Coulter - Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recove…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil B…
FDA Device · Class II · 2021-08-18 · Advance Dx - Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720
FDA Device · Class II · 2021-08-18 · Beckman Coulter - Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewi…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used thr…
FDA Device · Class II · 2021-08-18 · Shent Usa - Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. d…
FDA Device · Class II · 2021-08-18 · Medline Industries - ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 28500…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommend…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
FDA Device · Class II · 2021-08-18 · Richard Wolf - EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
FDA Device · Class II · 2021-08-18 · Bard Peripheral Vascular - Spectrum Medical Quantum Standard heat exchanger
FDA Device · Class II · 2021-08-18 · Qura S R L - ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
FDA Device · Class II · 2021-08-18 · Biomerieux - HeartWare HVAD Implant Kit, REF 1104JP
FDA Device · Class I · 2021-08-18 · Heartware - TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm
FDA Device · Class II · 2021-08-18 · Bard Peripheral Vascular - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
FDA Device · Class II · 2021-08-18 · Biomet - Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00
FDA Device · Class II · 2021-08-18 · Exactech - CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pe…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Device · Class I · 2021-08-18 · Heartware
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)