A voluntary recall notice for Lidocaine HCL Injection USP 1% 10mg/mL 5mL Ampules (Lidocaine Ampule) was issued to affected customers on 12 May 2026 for this limited list of lots: AE4013, AE5032, AE5039, AE5104.  The reason for recall by the contract manufacturer is due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.  Based upon review of the quality issues reported, Spectra Medical Devices has submitted its retained samples to independently verify product quality with respect to endotoxin and sterility release criteria for all Lidocaine Ampule lots that are within their expiry period.  All lots met the release criteria for endotoxin.  Lots listed did not meet release criteria for sterility.   

The product risk has been determined to be low, as the terminal sterilization overkill process provides a very high level of sterility assurance.  

All other lots not listed within their expiry period passed independent sterility and endotoxin verification testing and are not within the scope of this recall.

In February 2026, the Supreme Court of the United States ruled that the International Emergency Economic Powers Act (IEEPA) does not authorize the president to impose tariffs and therefore struck down the tariffs that were imposed in 2025.  

Elevaris Medical Devices, a Contract Development and Manufacturing Organization for industry-leading multi-national healthcare companies, announced the appointment of Lisa Perronne to its newly created role of Global Vice President, Quality Assurance and Regulatory Affairs (QARA).

Elevaris Medical Devices, the world-class Contract Development and Manufacturing Organization resulting from the acquisition of UK-based XL Precision Technologies by U.S.-based Spectra Medical Devices, is introducing its services and procedural needle portfolio to EMEA.

Elevaris Medical Devices, a Contract Development and Manufacturing Organization for industry-leading multi-national healthcare companies, announced the appointment of its new Chief Engineering and Operations Officer, Salvador Montes.

Elevaris is helping medical device companies speed up R&D with its XLerator live prototyping program—cutting weeks of design work down to just days through hands-on, in-factory collaboration.

In light of the April 2 announcement regarding new tariffs on U.S. global trading partners, we want to assure you that we are diligently analyzing the effect of these tariffs on our supply chain.

We wanted to provide our customers more details on our adoption of the Elevaris brand and what it means for operations going forward. In approaching this process, we had a goal of rebranding with as little disruption to our customers as possible.

Our rebrand is another significant milestone in our journey together since Spectra acquired XLPT in September 2024. It’s our promise to leverage the strengths of our individual brands while emphasizing our singular commitment to you.

Spectra Medical Devices (Spectra) and XL Precision Technologies (XLPT) announced today their newly combined brand presence as Elevaris Medical Devices, a world-class Contract Development and Manufacturing Organization (CDMO) leveraging a proven legacy of excellence to usher in a new era of precision medical device development and manufacturing capabilities.

Spectra Medical Devices, LLC (“Spectra”), a portfolio company of QHP Capital, is pleased to announce the closing of its acquisition of XLPrecision Technologies Ltd. (“XL-PT”). XL-PT is now a wholly-owned subsidiary of Spectra.

Spectra Medical Devices, a global manufacturer of made-to-spec procedural needles and a distributor of complementary medical instruments, supplies, and pharmaceuticals, today announced that it has secured European Union Medical Device Regulation (EU MDR) certification for its entire range of radiofrequency (RF) needles.