Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IIsmiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceSmiths Medical ASD Inc.Class IImedex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
- 2021-10-20FDA-DeviceRed Medical SuppliesClass IEcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
- 2021-10-20FDA-DeviceRed Medical SuppliesClass IEcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
- 2021-10-20FDA-DeviceRed Medical SuppliesClass IEcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
- 2021-10-20FDA-DeviceInpeco S.A.Class IIFlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
- 2021-10-20FDA-DeviceMedtronic Sofamor Danek USA IncClass IIEndoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Engraving on implants may not match what is listed on the pouch labels.
- 2021-10-20FDA-DeviceMedtronic Sofamor Danek USA IncClass IIEndoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Engraving on implants may not match what is listed on the pouch labels.
- 2021-10-20FDA-DeviceBioMerieux SAClass IIMYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Under certain conditions, there is a risk for a false negative result.
- 2021-10-20FDA-DeviceRoche Molecular Systems, Inc.Class IIcobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
- 2021-10-20FDA-DeviceBio-Rad Laboratories, Inc.Class IIBioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
- 2021-10-20FDA-DevicePhilips North America LLCClass IIPhilips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Customers were not notified of previous recalls associated with various defibrillator models.
- 2021-10-20FDA-DevicePhilips North America LLCClass IIPhilips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Customers were not notified of previous recalls associated with various defibrillator models.
- 2021-10-20FDA-DevicePhilips North America LLCClass IIPhilips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Customers were not notified of previous recalls associated with various defibrillator models.
- 2021-10-20FDA-DevicePhilips North America LLCClass IIPhilips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Customers were not notified of previous recalls associated with various defibrillator models.
- 2021-10-20FDA-DeviceW L Gore & Associates, Inc.Class IIHeparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
- 2021-10-20FDA-DeviceNational Distribution & Contracting IncClass IECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- 2021-10-20FDA-DeviceNational Distribution & Contracting IncClass IECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- 2021-10-20FDA-DeviceAbbott Molecular, Inc.Class IAlinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
There is a potential for false positive results.
- 2021-10-20FDA-DeviceAbbott Molecular, Inc.Class IAlinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
There is a potential for false positive results.
- 2021-10-20FDA-DeviceAbbott Molecular, Inc.Class IAlinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
There is a potential for false positive results.
- 2021-10-20FDA-DeviceAbbott Molecular, Inc.Class IAlinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
There is a potential for false positive results.
- 2021-10-20FDA-DeviceAbbott Molecular, Inc.Class IAlinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
There is a potential for false positive results.
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