FDA (Device enforcement)

11,102 recalls · page 24 of 112

• 3mensio Workstation (Vascular Fenestrated) software2025-07-14
• Spectrum IQ Infusion Pump, Product Code 35700092025-07-14
• Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.2025-07-14
• Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH,2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5) 2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Num2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/I2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSIN2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.2025-07-14
• AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOT2025-07-14
• Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK M2025-07-10
• Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 338602025-07-10
• Micro Joystick R-net. Electrical wheelchair component.2025-07-10
• Multi Joystick R-net. Electrical wheelchair component.2025-07-10
• IDM-MICRO-R. Electrical wheelchair component.2025-07-10
• IDM-MULTI-R. Electrical wheelchair component.2025-07-10
• All-round Joystick R-net Light. Electrical wheelchair component.2025-07-10
• IDM-ARLITE-R. Electrical wheelchair component.2025-07-10
• FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.2025-07-10
• Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.2025-07-09
• Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resusc2025-07-09
• VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;2025-07-09
• BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions2025-07-08
• BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF2025-07-08
• BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD2025-07-08
• BD Trucount Controls, 30 Test - REF: 3403352025-07-08
• Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual2025-07-08
• The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using Medline and other ma2025-07-08
• Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-092025-07-08
• epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.2025-07-07
• Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID 2025-07-07
• 3D9-3v Transducer Probe2025-07-03
• BP10-5ec Transducer Probe2025-07-03
• C10-3v Transducer Probe2025-07-03
• C10-4ec Transducer Probe2025-07-03
• c5-1 Transducer Probe2025-07-03
• C5-2 Transducer Probe2025-07-03
• C5-2 Lumify Transducer Probe2025-07-03
• C6-2 Transducer Probe2025-07-03
• C6-3 Transducer Probe2025-07-03
• C8-4v Transducer Probe2025-07-03
• C8-4v Transducer Probe2025-07-03
• C8-5 Transducer Probe2025-07-03
• C9-2 Transducer Probe2025-07-03
• C9-4 Transducer Probe2025-07-03
• C9-4v Transducer Probe2025-07-03
• C9-5ec Transducer Probe2025-07-03
• D2cwc Transducer Probe2025-07-03
• D2TCD Transducer Probe2025-07-03
• D5cwc Transducer Probe2025-07-03
• eL18-4 Transducer Probe2025-07-03
• L11-3 Transducer Probe2025-07-03
• L12-3 Transducer Probe2025-07-03
• L12-4 Transducer Probe2025-07-03
• L12-4 Lumify Transducer Probe2025-07-03
• L12-5 38mm Transducer Probe2025-07-03
• L12-5 50 Transducer Probe2025-07-03
• L15-7io Transducer Probe2025-07-03
• L17-5 Transducer Probe2025-07-03
• L18-5 Transducer Probe2025-07-03
• L8-4 Transducer Probe2025-07-03
• L9-3 Transducer Probe2025-07-03
• mC12-3 Transducer Probe2025-07-03
• mC7-2 Transducer Probe2025-07-03
• Mini Multi TEE Transducer Probe2025-07-03
• mL26-8 Transducer Probe2025-07-03
• OMNI III TEE Transducer Probe2025-07-03
• S12-4 Transducer Probe2025-07-03
• S3-1 Transducer Probe2025-07-03
• S4-1 Transducer Probe2025-07-03
• S4-1 Lumify Transducer Probe2025-07-03
• S4-2 Transducer Probe2025-07-03
• S5-2 Transducer Probe2025-07-03
• S7-3t Transducer Probe2025-07-03
• S7-2t Transducer Probe2025-07-03
• S8-3 Transducer Probe2025-07-03
• S8-3t Transducer Probe2025-07-03
• S9-2 Transducer Probe2025-07-03
• V6-2 Transducer Probe2025-07-03
• V9-2 Transducer Probe2025-07-03
• VL13-5 Transducer Probe2025-07-03
• X11-4t Transducer Probe2025-07-03
• X5-1 Transducer Probe2025-07-03
• X5-1c Transducer Probe2025-07-03
• X6-1 Transducer Probe2025-07-03
• X7-2 Transducer Probe2025-07-03
• X7-2t Transducer Probe2025-07-03
• X8-2t Transducer Probe2025-07-03
• XL14-3 Transducer Probe2025-07-03
• t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)2025-07-03
• Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-2352025-07-02
• Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-282025-07-02
• GE HealthCare OEC 9800.2025-07-02
• GE HealthCare OEC 9900 Elite C-arm Systems.2025-07-02
• JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, T2025-07-01
• HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)2025-06-30
• Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper2025-06-30