FDA Announces Recall of Olympus Thunderbeat II Shears
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Olympus Corporation of the Americas is recalling 830 units of the Thunderbeat II Shears due to a potential for detachment of a distal tip component during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references International. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of their Thunderbeat II Shears because of a potential for detachment of a distal tip component of the device during use. This recall is classified as Class II.
Which Products Are Affected
The affected product is the Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm, with Model Number TB2-0520FC. The UDI-DI Number is 04953170439995, and all Lot Numbers are included. A total of 830 units are affected, distributed internationally in the countries of Australia, Japan, Hong Kong, and Europe.
What You Should Do
Consumers who have the affected product should contact Olympus Corporation of the Americas at their address, 3500 Corporate Pkwy, Center Valley, PA 18034-8229, for information on returns or refunds, as the recall was initiated via e-mail.
Why This Matters
This recall involves medical devices that could pose a risk if the component detaches during use, potentially affecting patient safety in medical procedures. It highlights the importance of device integrity in healthcare settings.
Source
This recall information is attributed to the FDA, Recall Number Z-1851-2026. For more details, visit the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,228 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.