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All product recalls associated with Datascope Corp.
Total Recalls
1000
Past Year
1000
Class I (Serious)
143
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.
There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.
The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.
The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. The recommended maximum displayed head SAR is now 0.1 W/kg.
The recall involves Porter-Cable® 7¼-inch MAG-Saw™ Circular Saws with model numbers 324MAG (serial numbers 10001 through 108962), 325MAG (serial numbers 10001 through 014712), 423MAG (serial numbers 10001 through 100371), and 424MAG (serial numbers 10001 through 012690). The model and serial numbers are located on a label on the top of the saws. Units marked with a "T" at the location shown below have been inspected and are not affected by this recall. "Porter-Cable®" is written on the side of these saws.
When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.
Screwdriver handle breakage
Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)
Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
This recall involves 40-ounce white ceramic teapots with bamboo handles. The phrase "Microwave and Dishwasher Safe" is printed on the bottom of each teapot.
Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0
The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.
A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomoly can be corrected by reprogramming the Restore Neurostimulator using specific software.