FDA recall, , Moderate risk
OmniTract Surgical Retractor System
The OmniTract Surgical Retractor System has a dry time that needs to be extended.
Summary by Recall Canary from the FDA notice
What happened
Integra LifeSciences Corp. (NeuroSciences) of Princeton, New Jersey, recalled the OmniTract Surgical Retractor System, which includes 633 of the firm's product codes. The current instructions for use state a dry time of 30 minutes, but Integra LifeSciences 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 recall began June 5, 2026, and was added to the FDA's Enforcement Report on July 9, 2026.
The product was distributed worldwide, including nationwide in the US and in many other countries. The recall was classified by the FDA on July 9, 2026, and in the FDA's weekly enforcement report on July 15, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
- UDI-DI
- 10381780268468
- 10381780268505
- 10381780268512
- 10381780268529
- 10381780268536
- 10381780268550
- 10381780268567
- 10381780268581
- 10381780268598
- 10381780268604
- 10381780268680
- 10381780268697
- 10381780268710
- 10381780268734
- 10381780268758
- 10381780268826
- 10381780268833
- 10381780268857
- 10381780268871
- 10381780268888
- 10381780268895
- 10381780268901
- 10381780268918
- 10381780268925
- 10381780268932
- 10381780268994
- 10381780269038
- 10381780269045
- 10381780269052
- 10381780269076
- 10381780269083
- 10381780269168
- 10381780269212
- 10381780269243
- 10381780269250
- 10381780269267
- 10381780269274
- 10381780282273
- 10381780269281
- 10381780269298
- 10381780269304
- 10381780269311
- 10381780269328
- 10381780269335
- 10381780269342
- 10381780269359
- 10381780269366
- 10381780269373
- 10381780269380
- 10381780269397
- 10381780269403
- 10381780269410
- 10381780269427
- 10381780269434
- 10381780269441
- 10381780269458
- 10381780269465
- 10381780269472
- 10381780269489
- 10381780269496
- 10381780269502
- 10381780269519
- 10381780269526
- 10381780269533
- 10381780269540
- 10381780269557
- 10381780269564
- 10381780269571
- 10381780269588
- 10381780269595
- 10381780269601
- 10381780269618
- 10381780269625
- 10381780269632
- 10381780269649
- 10381780269656
- 10381780269663
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- 10381780269793
- 10381780269809
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- 10381780269823
- 10381780269830
- 10381780269847
- 10381780269854
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- 10381780269908
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- 10381780270362
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- 10381780270386
- 10381780270393
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- 10381780268420
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- 10381780268437
- 10381780268444
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- 10381780271604
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- 10381780271727
- 10381780271734
- 10381780271741
- 10381780271758
- 10381780271765
- 10381780271772
- 10381780271789
- 10381780271796
- 10381780271826
- 10381780271864
- 10381780271871
- 10381780271888
- 10381780271895
- 10381780271901
- 10381780271918
- 10381780271925
- 10381780271932
- 10381780271949
- 10381780271956
- 10381780271963
- 10381780271970
- 10381780271987
- 10381780271994
- 10381780272007
- 10381780272014
- 10381780272021
- 10381780272038
- 10381780272045
- 10381780272069
- 10381780272076
- 10381780272083
- 10381780272090
- 10381780272106
- 10381780272113
- 10381780272120
- 10381780272137
- 10381780272144
- 10381780272151
- 10381780272168
- 10381780272175
- 10381780272199
- 10381780272205
- 10381780272212
- 10381780272229
- 10381780272236
- 10381780272243
- 10381780272250
- 10381780272267
- 10381780272274
- 10381780272281
- 10381780272298
- 10381780272304
- 10381780272311
- 10381780272328
- 10381780272335
- 10381780272342
- 10381780272359
- 10381780272366
- 10381780272373
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- 10381780272397
- 10381780399490
- 10381780272403
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- 10381780272489
- 10381780282280
- 10381780272496
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- 10381780272564
- 10381780272571
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- 10381780272595
- 10381780272625
- 10381780272632
- 10381780272649
- 10381780272656
- 10381780272663
- 10381780272670
- 10381780272687
- 10381780272694
- 10381780272700
- 10381780272717
- 10381780272724
- 10381780272731
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- 10381780272755
- 10381780272762
- 10381780272779
- 10381780272786
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- 10381780272816
- 10381780272823
- 10381780272830
- 10381780272847
- 10381780272854
- 10381780271352
- 10381780271468
- 10381780271611
- 10381780271628
- 10381780271635
- 10381780271642
- 10381780271659
- 10381780271666
- 10381780271802
- 10381780271819
- 10381780271833
- 10381780271840
- 10381780271857
- 10381780272052
- 10381780272182
- 10381780272601
- 10381780268451
- 10381780268475
- 10381780282266
- 10381780268482
- 10381780268499
- 10381780268543
- 10381780268574
- 10381780268611
- 10381780268628
- 10381780268635
- 10381780268642
- 10381780268659
- 10381780268666
- 10381780268673
- 10381780268703
- 10381780268727
- 10381780268741
- 10381780268765
- 10381780268772
- 10381780268789
- 10381780268796
- 10381780268802
- 10381780268819
- 10381780268840
- 10381780268864
- 10381780268949
- 10381780268956
- 10381780268963
- 10381780268970
- 10381780268987
- 10381780269007
- 10381780269014
- 10381780269021
- 10381780269069
- 10381780269090
- 10381780269106
- 10381780269113
- 10381780269120
- 10381780269137
- 10381780269144
- 10381780269151
- 10381780269175
- 10381780269182
- 10381780269199
- 10381780269205
- 10381780269229
- 10381780269236
- 10381780269922
- 10381780269939
- 10381780269946
- 10381780269953
- 10381780269991
- 10381780270003
- 10381780270010
- 10381780270065
- 10381780270058
- 10381780270072
- 10381780270119
- 10381780270126
- 10381780270164
- 10381780270171
- 10381780270188
- 10381780270195
- 10381780270201
- 10381780270263
- 10381780270270
- 10381780270287
- 10381780270577
- 10381780270607
- 10381780270676
- 10381780270751
- 10381780270829
- 10381780270874
- 10381780511076
- 10381780413394
- 10381780272618
- 10381780511090
- 10381780511106
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea (the Republic of), Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands (the), New Zealand, Norway, Pakistan, Palestine, State of, Philippines (the), Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, R¿union, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Thailand, Trinidad and Tobago, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland, (the), Viet Nam.
- Company
- Integra LifeSciences Corp. (NeuroSciences)Princeton, New Jersey
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99193
- Recall number
- Z-2714-2026
- Quantity recalled
- 633 units
All recalls from Integra LifeSciences Corp. (NeuroSciences)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
