FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of ste…
FDA Device · Class II · 2023-01-11 · Steris - PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
FDA Device · Class II · 2023-01-11 · Biomerieux - VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
FDA Device · Class II · 2023-01-11 · Biomerieux - Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoa…
FDA Device · Class II · 2023-01-11 · Randox Laboratories - ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
FDA Device · Class II · 2023-01-11 · Biomerieux - ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
FDA Device · Class II · 2023-01-11 · Biomerieux - Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures
FDA Device · Class II · 2023-01-11 · Beaver Visitec International - Detect Covid-19 Test Product/Model Number: 21205
FDA Device · Class II · 2023-01-11 · Detect Headquarters - VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072
FDA Device · Class II · 2023-01-11 · Biomerieux - VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
FDA Device · Class II · 2023-01-11 · Biomerieux - VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routi…
FDA Device · Class II · 2023-01-11 · Steris - Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
FDA Device · Class II · 2023-01-11 · Medtronic Minimed - API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
FDA Device · Class II · 2023-01-11 · Biomerieux - API NIT1 NIT2 REAGENTS, CATALOG 70442
FDA Device · Class II · 2023-01-11 · Biomerieux - Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoa…
FDA Device · Class II · 2023-01-11 · Randox Laboratories - PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
FDA Device · Class II · 2023-01-11 · Biomerieux - VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
FDA Device · Class II · 2023-01-11 · Biomerieux - VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
FDA Device · Class II · 2023-01-11 · Biomerieux - VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
FDA Device · Class II · 2023-01-11 · Biomerieux - BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only
FDA Device · Class II · 2023-01-11 · Beckman Coulter - PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
FDA Device · Class II · 2023-01-11 · Biomerieux - GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
FDA Device · Class II · 2023-01-11 · Biomerieux - API JAMES 2AMP, CATALOG 70542
FDA Device · Class II · 2023-01-11 · Biomerieux - BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
FDA Device · Class II · 2023-01-11 · Biomerieux - VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
FDA Device · Class II · 2023-01-11 · Biomerieux - API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
FDA Device · Class II · 2023-01-11 · Biomerieux - TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
FDA Device · Class II · 2023-01-11 · Biomerieux - GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
FDA Device · Class II · 2023-01-11 · Biomerieux - 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
FDA Device · Class II · 2023-01-11 · Endo Pharmaceuticals Solutions - ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
FDA Device · Class II · 2023-01-11 · Biomerieux - ActiveAid 922, Shower/Commode Chair
FDA Device · Class II · 2023-01-11 · Altimate Medical - ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
FDA Device · Class II · 2023-01-11 · Biomerieux - VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of stea…
FDA Device · Class II · 2023-01-11 · Steris - API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
FDA Device · Class II · 2023-01-11 · Biomerieux - DeRoyal Tonsillectomy Tray, REF 89-10698.01
FDA Device · Class II · 2023-01-11 · Deroyal Industries - VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
FDA Device · Class II · 2023-01-11 · Biomerieux - PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
FDA Device · Class II · 2023-01-11 · Biomerieux - VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
FDA Device · Class II · 2023-01-11 · Biomerieux - Programmable Diagnostic Computer
FDA Device · Class II · 2023-01-11 · Siemens Medical Solutions Usa - VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
FDA Device · Class II · 2023-01-11 · Biomerieux - PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
FDA Device · Class II · 2023-01-11 · Biomerieux - API 20 E 25 STRIPS, CATALOG 20100
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
FDA Device · Class II · 2023-01-11 · Biomerieux - VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
FDA Device · Class II · 2023-01-11 · Biomerieux - ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
FDA Device · Class II · 2023-01-11 · Biomerieux - Pilling Wecksorb Cylindrical Sponges
FDA Device · Class II · 2023-01-04 · Teleflex - AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwis…
FDA Device · Class II · 2023-01-04 · Acumed - Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutra…
FDA Device · Class II · 2023-01-04 · Acumed - Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clav…
FDA Device · Class II · 2023-01-04 · Acumed - Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
FDA Device · Class II · 2023-01-04 · Remington Medical - Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acut…
FDA Device · Class II · 2023-01-04 · Acumed
Other years
2026 (2,088) · 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)