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.
- Vanta Clinician Programmer Application, Model A71200
FDA Device · Class II · 2022-08-31 · Medtronic Neuromodulation - BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP D…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model N…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437,…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Ki…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ve…
FDA Device · Class I · 2022-08-31 · Getinge Usa Sales - a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and…
FDA Device · Class II · 2022-08-31 · Getinge Usa Sales - FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - HAMILTON-C6 Intensive Care Ventilator, REF: 160021
FDA Device · Class I · 2022-08-31 · Hamilton Medical Ag - NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit
FDA Device · Class II · 2022-08-31 · Biomerieux - FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021
FDA Device · Class I · 2022-08-31 · Synapse Biomedical - GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Mod…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF…
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump
FDA Device · Class I · 2022-08-31 · Intera Oncology - Vanta Clinician Programmer Application, Model A71200
FDA Device · Class II · 2022-08-31 · Medtronic Neuromodulation - MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740
FDA Device · Class II · 2022-08-31 · Safe Orthopaedics - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 m…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124
FDA Device · Class II · 2022-08-31 · Deroyal Industries - a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tons…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKess…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX
FDA Device · Class II · 2022-08-31 · Ge Healthcare - Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTO…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Device · Class II · 2022-08-31 · Materialise Usa - Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Dynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide D…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - EVIS EXERA III Bronchovideoscope
FDA Device · Class II · 2022-08-31 · Aizu Olympus - Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (o…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
FDA Device · Class II · 2022-08-31 · Baxter Healthcare - a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde S…
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202
FDA Device · Class II · 2022-08-31 · Mckesson Medical Surgical Corporate Office - POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
FDA Device · Class II · 2022-08-24 · Abbott Molecular - KY JELLY LUBRICANT 2 FL OZ, SKU 901443
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - FIRST RESPONSE 2 CT, SKU 902343
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
FDA Device · Class I · 2022-08-24 · Heartware - CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - Veriquick Pregnancy Test 2CT, SKU 903756
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2
FDA Device · Class II · 2022-08-24 · Myolyn - FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974
FDA Device · Class III · 2022-08-24 · Siemens Medical Solutions Usa - DENTEMP ONE STEP .077OZ, SKU 902139
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - CURAD FIRST AID KIT, SKU 999037
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
FDA Device · Class II · 2022-08-24 · Trinity Sterile - SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 9…
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the tran…
FDA Device · Class II · 2022-08-24 · Becton Dickinson And - (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Heal…
FDA Device · Class II · 2022-08-24 · Aso - CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - GS SALINE SOLUTION 12FL OZ, SKU 902274
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
FDA Device · Class II · 2022-08-24 · Micro Therapeutics - Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
FDA Device · Class II · 2022-08-24 · Trinity Sterile - Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
FDA Device · Class II · 2022-08-24 · Micro Therapeutics - B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - ARIES SARS-CoV-2 Assay
FDA Device · Class II · 2022-08-24 · Luminex - CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
FDA Device · Class II · 2022-08-24 · Trinity Sterile - NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
FDA Device · Class II · 2022-08-24 · Stradis Medical - NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"
FDA Device · Class II · 2022-08-24 · Stradis Medical - Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
FDA Device · Class II · 2022-08-24 · Trinity Sterile - LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"
FDA Device · Class II · 2022-08-24 · Stradis Medical - TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
FDA Device · Class II · 2022-08-24 · Family Dollar Stores
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)