Class II U.S. Food and Drug Administration

Integra LifeSciences Corp. OmniTract Surgical Retractor System recall: The current Omni-Tract Surgical Retractor System IFU states a dry time of 30

Recall published 3 months ago

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.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2714-2026
Published
July 15, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Integra LifeSciences Corp.
Product type
Medical devices
Units affected
633 units
Distribution
Nationwide
Made in
United States
Lot / code info
Product Code 3032, UDI 10381780268468; Product Code 3055, UDI 10381780268505; Product Code 3069, UDI 10381780268512; Product Code 3076, UDI 10381780268529; Product Code 3086, UDI 10381780268536; Product Code 3092, UDI 10381780268550; Product Code 3093, UDI 10381780268567; Product Code 3096, UDI 10381780268581; Product Code 3098, UDI 10381780268598; Product Code 3099, UDI 10381780268604; Product Code 3133, UDI 10381780268680; Product Code 3137, UDI 10381780268697; Product Code 3142, UDI 10381780268710; Product Code 3146, UDI 10381780268734; Product Code 3148, UDI 10381780268758; Product Code 3176, UDI 10381780268826; Product Code 3177, UDI 10381780268833; Product Code 3185, UDI 10381780268857; Product Code 3201, UDI 10381780268871; Product Code 3203, UDI 10381780268888; Product Code 3216, UDI 10381780268895; Product Code 3217, UDI 10381780268901; Product Code 3218, UDI 10381780268918; Product Code 3219, UDI 10381780268925; Product Code 3220, UDI 10381780268932; Product Code 3274, UDI 10381780268994; Product Code 3312, UDI 10381780269038; Product Code 3335, UDI 10381780269045; Product Code 3336, UDI 10381780269052; Product Code 3342, UDI 10381780269076; Product Code 3343, UDI 10381780269083; Product Code 3391, UDI 10381780269168; Product Code 3398, UDI 10381780269212; Product Code 3424, UDI 10381780269243; Product Code 3426, UDI 10381780269250; Product Code 3483, UDI 10381780269267; Product Code 3485, UDI 10381780269274; Product Code 3520, UDI 10381780282273; Product Code 3529, UDI 10381780269281; Product Code 3530, UDI 10381780269298; Product Code 3531, UDI 10381780269304; Product Code 3532, UDI 10381780269311; Product Code 3533, UDI 10381780269328; Product Code 3534, UDI 10381780269335; Product Code 3535, UDI 10381780269342; Product Code 3536, UDI 10381780269359; Product Code 3537, UDI 10381780269366; Product Code 3555, UDI 10381780269373; Product Code 3557, UDI 10381780269380; Product Code 3565, UDI 10381780269397; Product Code 3570, UDI 10381780269403; Product Code 3575, UDI 10381780269410; Product Code 3586, UDI 10381780269427; Product Code 3588, UDI 10381780269434; Product Code 3590, UDI 10381780269441; Product Code 3592, UDI 10381780269458; Product Code 3593, UDI 10381780269465; Product Code 3594, UDI 10381780269472; Product Code 3595, UDI 10381780269489; Product Code 3596, UDI 10381780269496; Product Code 3597, UDI 10381780269502; Product Code 3601, UDI 10381780269519; Product Code 3602, UDI 10381780269526; Product Code 3603, UDI 10381780269533; Product Code 3604, UDI 10381780269540; Product Code 3605, UDI 10381780269557; Product Code 3610, UDI 10381780269564; Product Code 3614, UDI 10381780269571; Product Code 3616, UDI 10381780269588; Product Code 3618, UDI 10381780269595; Product Code 3620, UDI 10381780269601; Product Code 3622, UDI 10381780269618; Product Code 3623, UDI 10381780269625; Product Code 3624, UDI 10381780269632; Product Code 3626, UDI 10381780269649; Product Code 3630, UDI 10381780269656; Product Code 3631, UDI 10381780269663; Product Code 3635, UDI 10381780269670; Product Code 3640, UDI 10381780269687; Product Code 3647, UDI 10381780269694; Product Code 3650, UDI 10381780269700; Product Code 3654, UDI 10381780202936¿; Product Code 3700, UDI 10381780269717; Product Code 3720, UDI 10381780269724; Product Code 3732, UDI 10381780269731; Product Code 3740, UDI 10381780269748; Product Code 3759, UDI 10381780269755; Product Code 3761, UDI 10381780269762; Product Code 3763, UDI 10381780269779; Product Code 3765, UDI 10381780269786; Product Code 3772, UDI 10381780269793; Product Code 3774, UDI 10381780269809; Product Code 3780, UDI 10381780269816; Product Code 3782, UDI 10381780269823; Product Code 3784, UDI 10381780269830; Product Code 3786, UDI 10381780269847; Product Code 3788, UDI 10381780269854; Product Code 3790, UDI 10381780269861; Product Code 3792, UDI 10381780269878; Product Code 3794, UDI 10381780269885; Product Code 3796, UDI 10381780269892; Product Code 3798, UDI 10381780269908; Product Code 3800, U…
UPC codes
10381780268468, 10381780268505, 10381780268512, 10381780268529, 10381780268536, 10381780268550, 10381780268567, 10381780268581, 10381780268598, 10381780268604, 10381780268680, 10381780268697, 10381780268710, 10381780268734, 10381780268758, 10381780268826, 10381780268833, 10381780268857, 10381780268871, 10381780268888

Products covered by this recall

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

Check your product

The notice names 40 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10381780268468
  • 10381780268505
  • 10381780268512
  • 10381780268529
  • 10381780268536
  • 10381780268550
  • 10381780268567
  • 10381780268581
  • 10381780268598
  • 10381780268604
  • 10381780268680
  • 10381780268697
  • 10381780268710
  • 10381780268734
  • 10381780268758
  • 10381780268826
  • 10381780268833
  • 10381780268857
  • 10381780268871
  • 10381780268888

Model or item number

On the rating label, the box or the instruction sheet.

  • UDI 10381780268468
  • 3055
  • UDI 10381780268505
  • 3069
  • UDI 10381780268512
  • 3076
  • UDI 10381780268529
  • 3086
  • UDI 10381780268536
  • 3092
  • UDI 10381780268550
  • 3093
  • UDI 10381780268567
  • 3096
  • UDI 10381780268581
  • 3098
  • UDI 10381780268598
  • 3099
  • UDI 10381780268604
  • 3133

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Integra LifeSciences Corp. — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Integra LifeSciences Corp. (NeuroSciences) — 1100 Campus Rd, Princeton, NJ, 08540-6650

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Integra LifeSciences Corp. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10381780268468, 10381780268505, 10381780268512; model number UDI 10381780268468, 3055, UDI 10381780268505. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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