Medical Device
Manufacturing
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,476 records, page 247 of 1190
FDA device recalls, page 247 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0087-2023Class IIPositron Emission Tomography and Computed Tomography System, Model: uMI 550Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-1330-2022Class IIOSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and...Ossur AmericasISH
Z-0217-2024Class IILEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.Medtronic NeuromodulationMHY
Z-1427-2022Class IIGE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and...GE HealthcareBSZ
Z-1468-2022Class IIHammerTube Implant, 2.75mm, 10 Cannulated (Sterile)Paragon 28HTY
Z-1367-2022Class IIAnti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600...Ortho-Clinical Diagnostics, Inc.QKO
Z-1296-2022Class IISOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball...OLYMPUS Corporation of the AmericasGEX
Z-1809-2022Class IIIa. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b...Mckesson Medical-Surgical Inc. Corporate OfficeLRJ
Z-1808-2022Class IIIa. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1807-2022Class III3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1806-2022Class IIIa. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4"...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1805-2022Class IIIa. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1804-2022Class IIIa. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1803-2022Class IIIAbsorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1802-2022Class IIIMedical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model...Mckesson Medical-Surgical Inc. Corporate OfficeGAQ
Z-1801-2022Class IIISkin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO...Mckesson Medical-Surgical Inc. Corporate OfficeIYE
Z-1800-2022Class IIIa. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated...Mckesson Medical-Surgical Inc. Corporate OfficeGER
Z-1799-2022Class IIIa. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219...Mckesson Medical-Surgical Inc. Corporate OfficeGER
Z-1798-2022Class IIIa. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1797-2022Class IIIMERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model...Mckesson Medical-Surgical Inc. Corporate OfficeKGX
Z-1796-2022Class IIIa. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen /...Mckesson Medical-Surgical Inc. Corporate OfficeFRO
Z-1795-2022Class IIICooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.Mckesson Medical-Surgical Inc. Corporate OfficeFYD
Z-1794-2022Class IIIa. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M...Mckesson Medical-Surgical Inc. Corporate OfficeJOJ
Z-1793-2022Class IIIa. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch...Mckesson Medical-Surgical Inc. Corporate OfficeFRC
Z-1792-2022Class IIIa. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator...Mckesson Medical-Surgical Inc. Corporate OfficeJOJ
Z-1791-2022Class IIISPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide...Mckesson Medical-Surgical Inc. Corporate OfficeKCT
Z-1790-2022Class IIIa. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas /...Mckesson Medical-Surgical Inc. Corporate OfficeFRC
Z-1789-2022Class IIIDERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model...Mckesson Medical-Surgical Inc. Corporate OfficeKGN
Z-1788-2022Class IIIa. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl...Mckesson Medical-Surgical Inc. Corporate OfficeMPN
Z-1787-2022Class IIIDERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9%...Mckesson Medical-Surgical Inc. Corporate OfficeFQH
Z-1637-2022Class IIMEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY...Mckesson Medical-Surgical Inc. Corporate OfficeJSM
Z-1636-2022Class IIFISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712Mckesson Medical-Surgical Inc. Corporate OfficeJTW
Z-1635-2022Class IIDYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250Mckesson Medical-Surgical Inc. Corporate OfficeKMJ
Z-1634-2022Class IIDynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216Mckesson Medical-Surgical Inc. Corporate OfficeKXG
Z-1633-2022Class IIDYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202Mckesson Medical-Surgical Inc. Corporate OfficeKXG
Z-1632-2022Class IIMORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog...Mckesson Medical-Surgical Inc. Corporate OfficeOKV
Z-1631-2022Class IICOOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog...Mckesson Medical-Surgical Inc. Corporate OfficeHHW
Z-1630-2022Class IICENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS)...Mckesson Medical-Surgical Inc. Corporate OfficeFCN
Z-1629-2022Class IIBECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog...Mckesson Medical-Surgical Inc. Corporate OfficeGGK
Z-1628-2022Class IIFISHER SCIENTIFIC Aseptic Control LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog...Mckesson Medical-Surgical Inc. Corporate OfficeMMS
Z-1627-2022Class IIFISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721Mckesson Medical-Surgical Inc. Corporate OfficeJSM
Z-1626-2022Class IIBEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS...Mckesson Medical-Surgical Inc. Corporate OfficeHMX
Z-1625-2022Class IIBEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX)...Mckesson Medical-Surgical Inc. Corporate OfficeKCN
Z-1624-2022Class IIFISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015Mckesson Medical-Surgical Inc. Corporate OfficeJRC
Z-1623-2022Class IIa. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25...Mckesson Medical-Surgical Inc. Corporate OfficeFQM
Z-1622-2022Class IIDynarex PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501Mckesson Medical-Surgical Inc. Corporate OfficeLKB
Z-1621-2022Class IIMETREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number...Mckesson Medical-Surgical Inc. Corporate OfficeMNL
Z-1620-2022Class IIa. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model...Mckesson Medical-Surgical Inc. Corporate OfficeLRJ
Z-1619-2022Class IIa. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX...Mckesson Medical-Surgical Inc. Corporate OfficeNGT
Z-1618-2022Class IIa. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER...Mckesson Medical-Surgical Inc. Corporate OfficeJKA