FDA Device · 2022

FDA Device recalls in 2022

RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.

• K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
  FDA Device · Class II · 2022-11-30 · Kamiya Biomedical
• 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• regard BASIC NEURO, NU00259R, Item Number 800021018
  FDA Device · Class II · 2022-11-30 · Roi Cps
• 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• regard BASIC NEURO, NU00259S, Item Number 800021019
  FDA Device · Class II · 2022-11-30 · Roi Cps
• regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006
  FDA Device · Class II · 2022-11-30 · Roi Cps
• 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
  FDA Device · Class I · 2022-11-30 · Whele
• 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• Hamilton-C6
  FDA Device · Class II · 2022-11-30 · Hamilton Medical Ag
• regard NEURO PACK, NU00278L, Item Number 800040012
  FDA Device · Class II · 2022-11-30 · Roi Cps
• 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• regard SPINE PACK, NU00260H, Item Number 800022008
  FDA Device · Class II · 2022-11-30 · Roi Cps
• Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
  FDA Device · Class II · 2022-11-30 · Abbott Molecular
• 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
  FDA Device · Class II · 2022-11-30 · 3m Healthcare Business
• regard SHOULDER, GS00828G, Item Number 880367007
  FDA Device · Class II · 2022-11-30 · Roi Cps
• MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
  FDA Device · Class II · 2022-11-30 · Beckman Coulter
• EasyStand Bantam, with the following sizes. a. Small
  FDA Device · Class II · 2022-11-23 · Altimate Medical
• CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or wit…
  FDA Device · Class II · 2022-11-23 · Steris
• CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus…
  FDA Device · Class II · 2022-11-23 · Tollos
• 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen
  FDA Device · Class II · 2022-11-23 · Devilbiss Healthcare
• CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• 18239: ASM Omnipod Dash PDM, insulin delivery system
  FDA Device · Class I · 2022-11-23 · Insulet
• Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
  FDA Device · Class II · 2022-11-23 · Boston Scientific Neuromodulation
• CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLO…
  FDA Device · Class II · 2022-11-23 · Covidien
• CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• Philips Laser System, REF: LAS-100
  FDA Device · Class II · 2022-11-23 · Spectranetics
• CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116)
  FDA Device · Class II · 2022-11-23 · Teleflex
• GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
  FDA Device · Class II · 2022-11-23 · Sonendo
• CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
  FDA Device · Class II · 2022-11-23 · Texas Medical Technology
• Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L,…
  FDA Device · Class II · 2022-11-23 · Covidien
• BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative a…
  FDA Device · Class II · 2022-11-23 · Becton Dickinson And
• Hill-Rom Progressa Bed System
  FDA Device · Class II · 2022-11-23 · Baxter Healthcare
• Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
  FDA Device · Class II · 2022-11-23 · Howmedica Osteonics
• Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product
  FDA Device · Class II · 2022-11-23 · Medtronic Navigation
• CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System…
  FDA Device · Class II · 2022-11-23 · Novapproach Spine
• CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
  FDA Device · Class II · 2022-11-23 · Sonendo
• CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion
  FDA Device · Class II · 2022-11-23 · Lemaitre Vascular
• CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
  FDA Device · Class III · 2022-11-23 · Canadian Hospital Specialties
• Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
  FDA Device · Class II · 2022-11-23 · Getinge Usa Sales
• Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
  FDA Device · Class II · 2022-11-23 · Atrium Medical
• CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
  FDA Device · Class II · 2022-11-23 · Carefusion 2200
• Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CU…
  FDA Device · Class II · 2022-11-16 · Canon Medical System Usa
• Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿…
  FDA Device · Class II · 2022-11-16 · Alphatec Spine
• Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case
  FDA Device · Class II · 2022-11-16 · Fresenius Medical Care Holdings
• Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034
  FDA Device · Class II · 2022-11-16 · Irhythm Technologies
• ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early s…
  FDA Device · Class II · 2022-11-16 · Boston Scientific
• Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
  FDA Device · Class II · 2022-11-16 · Sedecal
• Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCT…
  FDA Device · Class II · 2022-11-16 · Avanos Medical
• Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
  FDA Device · Class II · 2022-11-16 · Access Vascular
• Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
  FDA Device · Class II · 2022-11-16 · Medtronic Minimed
• VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only
  FDA Device · Class II · 2022-11-16 · Ortho Clinical Diagnostics
• Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, a…
  FDA Device · Class II · 2022-11-16 · Beaver Visitec International
• NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
  FDA Device · Class II · 2022-11-16 · Coopersurgical
• ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, ea…
  FDA Device · Class II · 2022-11-16 · Boston Scientific
• X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration
  FDA Device · Class II · 2022-11-16 · X Nav Technologies
• Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
  FDA Device · Class II · 2022-11-16 · Cardinal Health 200
• Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754
  FDA Device · Class II · 2022-11-16 · Medtronic Minimed
• ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps,…
  FDA Device · Class II · 2022-11-16 · Boston Scientific
• FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend S…
  FDA Device · Class II · 2022-11-16 · Ferno Washington
• Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arteri…
  FDA Device · Class II · 2022-11-09 · Edwards Lifesciences
• MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures
  FDA Device · Class II · 2022-11-09 · Medline Industries Northfield
• BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures
  FDA Device · Class II · 2022-11-09 · Medline Industries Northfield
• Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev
  FDA Device · Class I · 2022-11-09 · Baxter Healthcare
• BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures
  FDA Device · Class II · 2022-11-09 · Medline Industries Northfield
• BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures
  FDA Device · Class II · 2022-11-09 · Medline Industries Northfield
• sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin
  FDA Device · Class II · 2022-11-09 · Sentec Ag
• CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470
  FDA Device · Class II · 2022-11-09 · Medline Industries Northfield
• BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
  FDA Device · Class II · 2022-11-09 · Becton Dickinson Infusion Therapy Systems
• Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B…
  FDA Device · Class I · 2022-11-09 · Baxter Healthcare
• BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures
  FDA Device · Class II · 2022-11-09 · Medline Industries Northfield
• EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile
  FDA Device · Class II · 2022-11-09 · Boston Scientific
• C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001
  FDA Device · Class II · 2022-11-09 · Baxter Healthcare
• Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903
  FDA Device · Class I · 2022-11-09 · Baxter Healthcare
• WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System
  FDA Device · Class II · 2022-11-09 · Microvention
• EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile
  FDA Device · Class II · 2022-11-09 · Boston Scientific

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)