Stat Surgical Supply

09/16/2026

Why would a Minnesota CDMO buy a Michigan metals shop?

Because robotic tools and catheter components are not commodities. When MIM, additive manufacturing, and finish machining sit in the same network, OEMs get a faster path—and hospitals get a better shot that the instrument set actually shows up.

We broke down what this deal means for surgical buyers, not just manufacturers.

Full story:

Precera Medical Acquires Additive Metal Services, Expanding MIM and Metal Additive Capacity for Surgical Components. Precera Medical, a Minnesota-based contrac...

05/22/2026

🚨 FDA Warning: Neurosurgical Supply Shortage May Continue Through 2026

The FDA is warning healthcare providers about shortages involving specialized neurosurgical patties and sponges used in brain and spine procedures.

These products are critical for:
✔ Protecting delicate tissue
✔ Absorbing fluids during surgery
✔ Maintaining surgical visibility

Hospitals and surgery centers are being advised to conserve inventory and secure alternative suppliers where possible.

https://www.statsurgicalsupply.com/news/fda-warns-neurosurgical-supply-shortage-could-disrupt-u-s-surgeries-through-end-of-2026

05/18/2026

⚠️ FDA Issues Serious Safety Classification for Certain Pacemakers

The FDA has classified a correction involving some Boston Scientific pacemakers and CRT-P devices as a Class I recall.

The issue may cause affected devices to enter “Safety Mode,” potentially impacting pacing and communication functions.

Healthcare providers are being advised to:
✔ Review affected device inventories
✔ Implement software updates
✔ Monitor impacted patients closely

This highlights how important software and battery reliability have become in modern medical devices.

https://www.statsurgicalsupply.com/news/fda-issues-class-i-recall-correction-for-boston-scientific-accolade-pacemakers-and-crt-p-devices

The U.S. Food and Drug Administration (FDA) has issued one of its most serious medical device safety classifications involving Boston Scientific’s ACCOLADE fami...

05/13/2026

⚠️ FDA Recall Alert for Omnipod 5 Insulin Pods

The FDA has announced a recall involving certain Omnipod 5 insulin pump pods due to possible interruptions or errors in insulin delivery.

Healthcare providers are being urged to:
✔ Check affected lot numbers
✔ Transition patients to alternative insulin delivery methods
✔ Monitor wearable devices during clinical care and procedures

As connected healthcare technology becomes more common, device reliability is more important than ever.

https://www.statsurgicalsupply.com/news/insulet-omnipod-5-pod-recall-signals-growing-risk-in-connected-drug-delivery-devices

05/07/2026

⚠️ Big changes may be coming to medical device access in the U.S.

The FDA and CMS have announced a new “RAPID” program aimed at speeding up Medicare coverage for breakthrough medical devices after FDA approval.

This could help hospitals and patients gain faster access to:
✔ Innovative surgical technologies
✔ Advanced implants and devices
✔ New treatment options for serious conditions

Healthcare leaders say the initiative may shorten coverage timelines dramatically.

https://www.statsurgicalsupply.com/news/cms-and-fda-launch-rapid-pathway-to-speed-medicare-coverage-for-breakthrough-medical-devices

04/29/2026

⚠️ Important Alert for Healthcare Providers

The FDA has issued an alert for certain dialysis catheter kits due to a risk of failure in one of the key components used during vascular access procedures.

Healthcare teams are advised to:
✔ Review and remove affected inventory
✔ Use alternative products
✔ Stay updated on FDA communications

Even a single defective component can impact an entire procedure.

https://www.statsurgicalsupply.com/news/fda-flags-removal-of-arrow-dialysis-catheter-kits-raising-supply-chain-and-procedure-risk-concerns

The U.S. Food and Drug Administration issued an early alert on April 24, 2026, regarding the removal of specific dialysis catheter kits manufactured by Arrow In...

04/27/2026

A major FDA inspection update could affect the future of surgical device supply.

The FDA’s new QMSR framework is changing how medical device manufacturers are inspected, with stronger focus on risk management, supplier controls, internal audits, and quality systems.

For hospitals and surgical suppliers, this means compliance readiness is becoming part of supply reliability.

https://www.statsurgicalsupply.com/news/fda-s-april-14-qmsr-inspection-update-signals-a-new-compliance-era-for-u-s-surgical-device-suppliers

04/24/2026

⚠️ FDA Issues Serious Recall Classification for Stryker TMJ Implants

The FDA has classified a correction involving certain Stryker patient-fitted TMJ implants as a Class I recall, the agency’s most serious category.

The concern involves screw placement risk during implantation, including a reported case where a screw penetrated the cranial vault.

Hospitals and surgical teams should review affected inventory, follow updated instructions, and continue monitoring patients according to standard follow-up protocols.

https://www.statsurgicalsupply.com/news/stryker-tmj-implant-correction-draws-fds-s-most-serious-recall-classification-after-skull-penetration-report

WASHINGTON, April 20, 2026 — The U.S. Food and Drug Administration has classified Stryker’s correction involving certain patient-fitted temporomandibular joint ...

04/20/2026

⚠️ Important Safety Alert for Healthcare Providers

The FDA has issued a serious recall for certain angiographic syringes due to a risk of disconnection during use.

This could lead to:
✔ Air entering the bloodstream
✔ Blood loss or infection
✔ Procedure interruptions

Healthcare facilities are advised to review inventory and remove affected products immediately.

Even small medical devices play a big role in patient safety.

https://www.statsurgicalsupply.com/news/medline-angiographic-syringe-recall-raises-immediate-safety-and-procurement-concerns-for-u-s-procedure-rooms

04/15/2026

⚠️ Important Update for Healthcare Teams

The FDA has issued an alert for certain vascular sizing catheters due to a risk of breakage during procedures.

Even though it’s not yet a recall, healthcare providers are being advised to:
✔ Stop using affected products
✔ Review and quarantine inventory
✔ Use alternative devices

This highlights how critical device safety is—even for tools used in routine procedures.

https://www.statsurgicalsupply.com/news/fda-early-alert-on-cook-medical-sizing-catheters-signals-a-high-impact-watch-item-for-interventional-supply-chains

The FDA’s April 9, 2026 early alert on certain Cook Medical sizing catheters is not yet a confirmed recall, but it is already significant news for the U.S. medi...