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.
- 2021-10-06FDA-DeviceOlympus Corporation of the AmericasClass IIBF-N20 OES Bronchofiberscope, Model No. BF-N20
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- 2021-10-06FDA-DeviceElekta IncClass IIElekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
- 2021-10-06FDA-DeviceLymol Medical CorporationClass IILYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420
Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision.
- 2021-10-06FDA-DeviceWOM World of Medicine AGClass IICovidien HysteroLux Fluid Management System Control Unit, REF: 72205000
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOutlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOutlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOutlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIPUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIY-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIV1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOutlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class II10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class II60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOutlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class IIOutlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceB. Braun Medical, Inc.Class II15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- 2021-10-06FDA-DeviceVascutek, Ltd.Class IIThe Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
- 2021-10-06FDA-DeviceVascutek, Ltd.Class IIThe Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Te
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
- 2021-10-06FDA-DeviceAccelerated Care Plus CorporationClass IOmnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
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
- 2021-10-06FDA-DeviceDeroyal Industries, Inc. LafolletteClass IDeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.
- 2021-10-06FDA-DeviceGreiner Bio-One North America, Inc.Class IIVACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Blood collection tubes may experience a clotting issue.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
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