🏥 Medical Devices Class I - Dangerous
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
All Recalls
95,089 total recalls in our database
Out of Specification Microbiological test results
🏥 Medical Devices Class I - Dangerous
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
🏥 Medical Devices Class I - Dangerous
Tubing detachment
🏥 Medical Devices Class I - Dangerous
Labeling inconsistency
Rigid Suction Canister 3000 CC and 2000 CC.
Medline Industries
🏥 Medical Devices Class I - Dangerous
Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
Epimed International
🏥 Medical Devices Class I - Dangerous
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
🏥 Medical Devices Class I - Dangerous
Tubing detachment
🏥 Medical Devices Class I - Dangerous
Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.
🏥 Medical Devices Class I - Dangerous
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
🏥 Medical Devices Class I - Dangerous
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
🏥 Medical Devices Class I - Dangerous
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
🏥 Medical Devices Class I - Dangerous
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Encore Medical
🏥 Medical Devices Class I - Dangerous
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
🏥 Medical Devices Class I - Dangerous
Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.
🏥 Medical Devices Class I - Dangerous
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
🏥 Medical Devices Class I - Dangerous
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
🏥 Medical Devices Class I - Dangerous
B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life.
🏥 Medical Devices Class I - Dangerous
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
🏥 Medical Devices Class I - Dangerous
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.