Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIDynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIDYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIMORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IICOOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IICENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIBECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIFISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIFISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721
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- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIBEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIBEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIFISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIa. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIDynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIMETREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIa. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000. d. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE PUMP SPRAY 24OZ METREX Catalog #13-1024. e. CaviCide1 DISINFECTANT, CLNR CAVICIDE1 24OZ (12/CS) METREX Catalog #13-5024. f.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIa. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIa. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988. c. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 5MLPLAS VACUTAINER (100/BX) Model Number: 367986. d. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY7.5ML PLAS VACUTAINER (100/BX) Model Number: 367987. e. BECTO
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIa. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICKINSON BD Vacutainer COLLECTION KIT, URINE COMPLETE 8ML 13"X75" (50/CS) BD Model Number: 364957
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIB. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIMedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIa. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400. e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LN
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIMckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIFischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIMEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIMEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIMEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass II3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIGETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IIa. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2022-08-31FDA-DeviceMckesson Medical-Surgical Inc. Corporate OfficeClass IISTERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
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