Recalls
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Boston Scientific recall of spinal cord stimulator leads tied to more than 1,000 injuries
A problem with the leads could cause inadequate stimulation, Boston Scientific said. In the worst case, leads may need to be removed or replaced.
By Susan Kelly • Sept. 4, 2026 -
Medtronic recalls pH monitoring capsule linked to 184 serious injuries
For the second time in two years, Medtronic has pulled capsules from the market over a fault that could obstruct patients’ airways.
By Nick Paul Taylor • Aug. 28, 2026 -
J&J’s latest Impella recall tied to 3 deaths, 37 injuries
Hospitals can use automated controllers in inventory while waiting for service from J&J’s Abiomed business to ensure patients who need Impella heart pumps can still receive care.
By Susan Kelly • Aug. 27, 2026 -
BD recalls intraosseous needle sets associated with 4 deaths
Some needles were manufactured with incorrect dimensions, making it difficult to remove the stylet after placement.
By Elise Reuter • Aug. 5, 2026 -
Boston Scientific removes stroke prevention catheter after injury
The device, bought during Boston Scientific’s acquisition of Silk Road Medical, has a risk of catheter tip separation during use.
By Elise Reuter • July 27, 2026 -
Resmed ventilator safety issue linked to 5 serious injuries
The supply of the circuit boards needed to fix the devices is significantly constrained, preventing the company from immediately correcting all affected ventilators.
By Nick Paul Taylor • July 20, 2026 -
Medtronic recalls heart valve delivery catheter for risk of tip detaching
Certain delivery systems that are used to insert a pulmonary valve have an increased risk of distal tip detachment, the company said. The valve itself is not affected by the recall.
By Elise Reuter • July 14, 2026 -
Terumo recalls stent-graft system linked to three deaths
Terumo has yet to establish a direct causal relationship between the deaths and the delivery system separation issues.
By Nick Paul Taylor • July 2, 2026 -
Retrieved from Hologic on January 16, 2025
FDA updates Hologic BioZorb recall, citing 252 injuries
While the company no longer manufactures the radiographic markers, healthcare providers are still advised to monitor patients who have had them implanted.
By Susan Kelly • July 1, 2026 -
FDA posts early alert over device used with Impella heart pumps
J&J’s Abiomed and manufacturing partner Oscor warned of a bleeding risk from devices used to introduce catheters to the body.
By Nick Paul Taylor • June 22, 2026 -
Zoll receives FDA warning letter over quality concerns
The FDA cited problems with some of Zoll’s ventilators, automated external defibrillators and electrodes.
By Elise Reuter • Updated June 22, 2026 -
J&J recalls Impella controllers over hardware issues
The correction is the latest recall that J&J’s Abiomed has issued in recent years for Impella devices and controllers.
By Nick Paul Taylor • June 12, 2026 -
J&J recalls Impella heart pumps after patient dies
Johnson & Johnson asked customers to quarantine and return affected products. A spokesperson said J&J conducted quality system audits as part of its integration of Abiomed that resulted in some field actions.
By Nick Paul Taylor • May 29, 2026 -
Insulet recalls 7M patch pumps due to leak risk
The recall is Insulet’s second this year related to tears in the device tubing. So far, 24 serious adverse events have been reported.
By Elise Reuter • May 27, 2026 -
Dexcom warns of scrapped glucose sensors being resold
Dexcom has identified two lots of G7 sensors that have been stolen, sold and used by customers.
By Elise Reuter • Updated May 27, 2026 -
J&J corrects Impella controller over issue linked to 2 injuries, 1 death
The controller can stop for about 35 seconds, during which time the patient is unsupported by the heart pump.
By Nick Paul Taylor • May 26, 2026 -
4 medtech manufacturers recall kits over problem with Medline syringes
AVID Medical, Aligned Medical Solutions, Medical Action Industries and American Contract Systems all sent notices to customers about convenience kits that contain recalled Medline angiographic syringes.
By Elise Reuter • May 13, 2026 -
Medline recalls angiographic syringes, receives FDA warning letter
The company removed the devices from the market in February following complaints of the syringes disconnecting from manifolds.
By Elise Reuter • April 14, 2026 -
Philips warns not to use certain nebulizers in Trilogy Evo ventilator recall
Using non-pneumatic nebulizers with the ventilators can lead to under-delivery of therapy to patients, the company said.
By Elise Reuter • Updated April 9, 2026 -
Intuitive Surgical recalls stapler reloads over issue linked to patient death
The recall follows reports of incomplete staple lines in procedures using the company’s da Vinci surgical robots.
By Nick Paul Taylor • March 19, 2026 -
Insulet reports 18 serious adverse events with recall of Omnipod 5 insulin pumps
The company is recalling certain lots of its insulin patch pumps after finding a small tear in the internal tubing may cause insulin to leak inside the pod.
By Elise Reuter • March 13, 2026 -
Retrieved from Fresenius Kabi on March 03, 2026
Fresenius Kabi recalls Ivenix infusion pumps over software problem
Fresenius has issued a software release to address issues that could interrupt treatment with its Ivenix large volume pumps.
By Elise Reuter • March 3, 2026 -
FDA posts early alert for safety issue with Impella heart pump devices
The cassettes have an increased risk of purge leaks that can lead to the loss of hemodynamic support.
By Nick Paul Taylor • Feb. 26, 2026 -
Medline addresses bed fire risk linked to death
The FDA said hand pendants and cords may overheat, causing the devices to spark, burn, melt, smoke and catch fire.
By Nick Paul Taylor • Feb. 18, 2026 -
J&J recalls coil systems used in aneurysm treatment
Healthcare providers are advised to stop using the devices after a failure to detach was linked with four serious injuries and one death.
By Susan Kelly • Feb. 6, 2026