FDA Device · 2019

FDA Device recalls in 2019

RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.

• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1 SH, .070", REF SA6MB1SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an i…
  FDA Device · Class II · 2019-10-09 · The Metrix
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous adm…
  FDA Device · Class II · 2019-10-09 · The Metrix
• TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with…
  FDA Device · Class II · 2019-10-09 · Howmedica Osteonics
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR405. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quanti…
  FDA Device · Class II · 2019-10-09 · Roche Diabetes Care
• TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during r…
  FDA Device · Class II · 2019-10-09 · Howmedica Osteonics
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
  FDA Device · Class II · 2019-10-09 · Inter Med
• SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture…
  FDA Device · Class II · 2019-10-09 · The Metrix
• TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with T…
  FDA Device · Class II · 2019-10-09 · Howmedica Osteonics
• SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an i…
  FDA Device · Class II · 2019-10-09 · The Metrix
• SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture…
  FDA Device · Class II · 2019-10-09 · The Metrix
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.5, .070", REF SA6SL35. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
  FDA Device · Class II · 2019-10-09 · Quality Electrodynamics
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
  FDA Device · Class II · 2019-10-09 · Inter Med
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5 SH, .070", REF SA6JR35SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
  FDA Device · Class II · 2019-10-09 · Quality Electrodynamics
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative mo…
  FDA Device · Class II · 2019-10-09 · Stryker Instruments Div
• The Access Cortisol Reagent
  FDA Device · Class II · 2019-10-09 · Beckman Coulter
• TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
  FDA Device · Class II · 2019-10-09 · Quality Electrodynamics
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT SH .070", REF SA63DRIGHTSH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
  FDA Device · Class II · 2019-10-09 · Merit Medical Systems
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0, .070", REF SA6JL30. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous adm…
  FDA Device · Class II · 2019-10-09 · The Metrix
• TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with…
  FDA Device · Class II · 2019-10-09 · Howmedica Osteonics
• ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile
  FDA Device · Class II · 2019-10-09 · Implant Direct Sybron Manufacturing
• Cascade Abrazo aPTT Test Card, Model 5722, For Export Only
  FDA Device · Class II · 2019-10-09 · Helena Laboratories
• Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
  FDA Device · Class II · 2019-10-09 · Inter Med
• SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Mi…
  FDA Device · Class II · 2019-10-09 · Inter Med
• Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is d…
  FDA Device · Class II · 2019-10-09 · Zimmer
• L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path
  FDA Device · Class II · 2019-10-09 · Baxter Healthcare
• SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0, .070", REF SA6JR30. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, LONG TIP, .070", REF SA6ERADLLT. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0 SH, .070", REF SA6JL60SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous adm…
  FDA Device · Class II · 2019-10-09 · The Metrix
• SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular
• SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular use
  FDA Device · Class I · 2019-10-09 · Medtronic Vascular

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)