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.

• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
  FDA Device · Class II · 2023-01-25 · Bolton Medical
• AXIOM Luminos Agile
  FDA Device · Class II · 2023-01-25 · Siemens Medical Solutions Usa
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• MobiCT-32 AIRO Mobile CT Scanner, Cat
  FDA Device · Class II · 2023-01-25 · Mobius Imaging
• PICC KIT, 10/CS, ACCESS MEDICAL LABEL
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 88…
  FDA Device · Class I · 2023-01-18 · Covidien
• Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
  FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
• Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• 7.5 cm Large Rotating Craniotome Attachment
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
  FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
• Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• BD Pyxis MedBank System - Product Label/labeling pending
  FDA Device · Class II · 2023-01-18 · Carefusion 303
• HCT CENTRAL LINE Insertion Tray, I2 per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of…
  FDA Device · Class II · 2023-01-18 · Siemens Healthcare Diagnostics
• 6.5 cm Adult Rotating Craniotome Attachment
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile
  FDA Device · Class II · 2023-01-18 · International Medical Industries
• Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, R…
  FDA Device · Class I · 2023-01-18 · Philips Respironics
• RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229
  FDA Device · Class I · 2023-01-18 · Emergent Protective Products Usa
• Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• Henry Shein CYSTO SET UP PACK, 20 per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Philips Garbin Ventilator, Model Number 1058180B
  FDA Device · Class I · 2023-01-18 · Philips Respironics
• 6.5 cm Pediatric Craniotome Attachment
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• RadiaLux Lighted Retractor (Pink), REF: 50-101-1
  FDA Device · Class II · 2023-01-18 · Medtronic Navigation
• Codman Surgical Patties, Part number 801400
  FDA Device · Class II · 2023-01-18 · Integra Lifesciences
• HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8)
  FDA Device · Class II · 2023-01-18 · Depuy Ireland Uc
• 6.5 cm Adult Rotating Craniotome Attachment
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Stradis Healthcare TCTR Convenience Kit
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) f…
  FDA Device · Class II · 2023-01-18 · Siemens Healthcare Diagnostics
• Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• McCormick Medical Distribution PORT TRAY, 25 trays per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
  FDA Device · Class II · 2023-01-18 · Deroyal Industries
• 6.5 cm Adult Craniotome, Thin Foot Plate Attachment
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
  FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
• 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
  FDA Device · Class II · 2023-01-18 · Corelink
• Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• cobas infinity central lab, Material Number 07154003001
  FDA Device · Class II · 2023-01-18 · Roche Diagnostics Operations
• Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
  FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
• Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP…
  FDA Device · Class I · 2023-01-18 · Philips Respironics
• HCT MAX BARRIER PICC INSERTION TRAY 12 per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Medline CISION Sterile Blades
  FDA Device · Class II · 2023-01-18 · Medline Industries Northfield
• Pediatric Craniotome Ref:CRANI-P-G1
  FDA Device · Class II · 2023-01-18 · The Anspach Effort
• Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case
  FDA Device · Class II · 2023-01-18 · Stradis Healthcare
• Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
  FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
• COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
  FDA Device · Class II · 2023-01-18 · Covidien
• VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 080085400…
  FDA Device · Class II · 2023-01-18 · Ventana Medical Systems
• Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number:…
  FDA Device · Class II · 2023-01-18 · Bayer Medical Care
• Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor
  FDA Device · Class II · 2023-01-18 · Philips North America
• ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
  FDA Device · Class II · 2023-01-11 · Biomerieux
• PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in huma…
  FDA Device · Class II · 2023-01-11 · Ortho Clinical Diagnostics
• VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
  FDA Device · Class II · 2023-01-11 · Biomerieux
• BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017
  FDA Device · Class II · 2023-01-11 · Biomerieux
• Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy…
  FDA Device · Class II · 2023-01-11 · Windstone Medical Packaging
• VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
  FDA Device · Class II · 2023-01-11 · Biomerieux
• DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
  FDA Device · Class II · 2023-01-11 · Biomerieux
• PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
  FDA Device · Class II · 2023-01-11 · Biomerieux
• BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
  FDA Device · Class II · 2023-01-11 · Biomerieux
• Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Cat…
  FDA Device · Class II · 2023-01-11 · Randox Laboratories
• PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
  FDA Device · Class II · 2023-01-11 · Biomerieux
• API VP1 VP2 REAGENTS, CATALOG 70422
  FDA Device · Class II · 2023-01-11 · Biomerieux
• PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routin…
  FDA Device · Class II · 2023-01-11 · Steris
• PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
  FDA Device · Class II · 2023-01-11 · Biomerieux
• PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
  FDA Device · Class II · 2023-01-11 · Biomerieux
• BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
  FDA Device · Class II · 2023-01-11 · Biomerieux
• VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
  FDA Device · Class II · 2023-01-11 · Biomerieux
• ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
  FDA Device · Class II · 2023-01-11 · Biomerieux

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)