Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-12-06FDA-DevicePATHClass IIAuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Affected lots of product may experience technical distortions to a greater extent than expected.
- 2023-12-06FDA-DevicePATHClass IISENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Affected lots of product may experience technical distortions to a greater extent than expected.
- 2023-12-06FDA-DevicePATHClass IISENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Affected lots of product may experience technical distortions to a greater extent than expected.
- 2023-12-06FDA-DeviceBecton Dickinson Infusion Therapy Systems Inc.Class IIBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
- 2023-11-29FDA-DeviceLEONI CIA CABLE SYSTEMSClass IIORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
- 2023-11-29FDA-DeviceLEONI CIA CABLE SYSTEMSClass IIORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
- 2023-11-29FDA-DeviceBoston Scientific CorporationClass IIEXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Poor image quality due to fluid ingress in the lens.
- 2023-11-29FDA-DeviceBoston Scientific CorporationClass IIEXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Poor image quality due to fluid ingress in the lens.
- 2023-11-29FDA-DevicePhilips North America LlcClass IISmartPath to dStream for 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DevicePhilips North America LlcClass IIIntera 1.5T Power/Pulsar
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DevicePhilips North America LlcClass IIIntera 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DevicePhilips North America LlcClass IIIngenia 1.5T CX
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DevicePhilips North America LlcClass IIAchieva 1.5T Initial System
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DevicePhilips North America LlcClass IIAchieva 1.5T Conversion
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DevicePhilips North America LlcClass IIAchieva 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-29FDA-DeviceBiomet, Inc.Class IICompress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178408
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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