Integra LifeSciences Recalls OmniTract Surgical Retractor System
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Integra LifeSciences Corp. is recalling 633 units of the OmniTract Surgical Retractor System due to insufficient dry times stated in the instructions for use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references United States. 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, medical-devices.
What Happened
Integra LifeSciences Corp. (NeuroSciences) initiated a voluntary recall of the OmniTract Surgical Retractor System after identifying that the current instructions for use (IFU) state a dry time of 30 minutes. The firm determined the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Which Products Are Affected
The recall covers the OmniTract Surgical Retractor System, which includes 633 of the firm's product codes. A total of 633 units are affected. The recall number is Z-2714-2026. Distribution was nationwide in the United States and to numerous countries worldwide including Australia, Canada, China, Germany, Japan, and the United Kingdom.
What You Should Do
The recalling firm initiated the recall via letter notification. Customers should follow the updated dry times in the revised IFU based on sterilization cycle exposure.
Why This Matters
This Class II recall addresses a potential issue with device reprocessing that could affect sterilization effectiveness for surgical retractors distributed globally.
Source
FDA recall Z-2714-2026; event ID 99193. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,198 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.