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.
- 2021-12-29FDA-DeviceCivco Medical Instruments Co. Inc.Class IIVirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- 2021-12-29FDA-DeviceCivco Medical Instruments Co. Inc.Class IIVirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- 2021-12-29FDA-DeviceCivco Medical Instruments Co. Inc.Class IIVirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- 2021-12-29FDA-DeviceCivco Medical Instruments Co. Inc.Class IIVirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- 2021-12-29FDA-DeviceCardiovascular Systems IncClass IWIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
- 2021-12-29FDA-DeviceWright Medical Technology IncClass IIStryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
The incorrect product is contained in the packaging.
- 2021-12-29FDA-DeviceWright Medical Technology IncClass IIStryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
The incorrect product is contained in the packaging.
- 2021-12-29FDA-DeviceMedtronic Navigation, Inc.Class IStealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.
- 2021-12-22FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IIMedical Device Identification Cards associated with Astra XT DR Implantable pulse generator
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
- 2021-12-22FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IIMedical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
- 2021-12-22FDA-DeviceXstrahl LimitedClass IITreatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Base plate may detach from the main body of the treatment applicator.
- 2021-12-22FDA-DeviceCook Inc.Class IIFlexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
- 2021-12-22FDA-DeviceCook Inc.Class IIFlexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
- 2021-12-22FDA-DeviceActivbody, Inc.Class IIactivforce 2 package labeling: Model: Activ5-M R 201-200563
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.
- 2021-12-22FDA-DeviceActivbody, Inc.Class IIBox Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.
- 2021-12-22FDA-DeviceCryoLife, Inc.Class IIBioGlue Surgical Adhesive, Model BG3510-5-G
Product is not approved for use in the EU and should not have been distributed in the EU.
- 2021-12-22FDA-DeviceClark Laboratories, Inc.Class IIBartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
- 2021-12-22FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
- 2021-12-22FDA-DeviceOssur AmericasClass IIMiami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
- 2021-12-22FDA-DeviceOlympus Corporation of the AmericasClass IIEVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
- 2021-12-22FDA-DeviceCardinal HealthClass IIRoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IIRoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IIRoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IIRoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IICardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IICardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IICardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IISmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IISmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Potential for open packaging seals compromising the sterility of the surgical gowns
- 2021-12-22FDA-DeviceCardinal HealthClass IISmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Potential for open packaging seals compromising the sterility of the surgical gowns
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