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.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-12-04FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
- 2024-12-04FDA-DeviceRemote Diagnostic Technologies Ltd.Class IIITempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
- 2024-12-04FDA-DeviceShimadzu Corp. Analytical & Measuring Instruments Div.Class IIAutosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.
- 2024-12-04FDA-DeviceShimadzu Corp. Analytical & Measuring Instruments Div.Class IIAutosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
- 2024-12-04FDA-DeviceAbbott MedicalClass IIIMerlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patient
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
- 2024-12-04FDA-DeviceAbbott MedicalClass IIIMerlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
- 2024-12-04FDA-DeviceGE Healthcare (China) Co., Ltd.Class IIGE Proteus XR/A radiographic system
Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
- 2024-12-04FDA-DeviceINCIPIO DEVICESClass IIOffset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIST SENSE Breast Dx Coil
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIST SENSE Breast Coil
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IISENSE Breast Coil 3.0T 7ch
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IISENSE Breast Coil
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIMammotrak Interventional Coil 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIMammotrak Diagnostic Coil 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIMammotrak Interventional Coil 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIMammotrak Diagnostic Coil 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIdS Breast 7ch 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIdS Breast 7ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIdS Breast 16ch 3.0T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
- 2024-12-04FDA-DevicePhilips North America LlcClass IIdS Breast 16ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
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