Data Foundry

Medical device recalls 2026

OmniTract Surgical Retractor System — Class II medical device recall Z-2714-2026

Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2026-07-15, distributed nationwide. The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has

Recall numberZ-2714-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmIntegra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States
Recall initiated2026-06-05
Classified2026-07-09
Reported by FDA2026-07-15
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BD, BE, BG, CA, CH, CL, CN, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IS, IT, JO, JP, KR, KW, LK, LT, MT, MX, MY, NL, NO, NP, NZ, PH, PK, PL, PT, QA, SA, SE, SG, SI, TH, TR, TT, TW, VN, ZA
Quantity633 units
UPC / GTIN / UDI-DI10381780202936, 10381780268413, 10381780268420, 10381780268437, 10381780268444, 10381780268451, 10381780268468, 10381780268475, 10381780268482, 10381780268499, 10381780268505, 10381780268512, 10381780268529, 10381780268536, 10381780268543, 10381780268550, 10381780268567, 10381780268574, 10381780268581, 10381780268598, 10381780268604, 10381780268611, 10381780268628, 10381780268635, 10381780268642 and 428 more

Product

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

Reason for recall

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2714-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.