Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
All Recalls
95,075 total recalls in our database
Mammotrak Interventional Coil 3.0T
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Gauthier Biomedical
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
Securitas Healthcare
Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
MEDLINE INDUSTRIES, LP - Northfield
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Mammotrak Diagnostic Coil 1.5T
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
MEDLINE INDUSTRIES, LP - Northfield
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Due to pin coming off of handles.
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical ASD
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
MEDLINE INDUSTRIES, LP - Northfield
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
MEDLINE INDUSTRIES, LP - Northfield
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Baxter Healthcare
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.
dS Breast 7ch 3.0T
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
GE Medical Systems
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
GE Proteus XR/A radiographic system
GE Healthcare (China) Co.
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.
For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
ST SENSE Breast Dx Coil
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
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.