FDA recall, , Moderate risk
DEX Ophthalmic Tissue Forceps
DEX Ophthalmic Tissue Forceps have a field safety corrective action for their instructions for use.
Summary by Recall Canary from the FDA notice
What happened
Katalyst Surgical, LLC, of Chesterfield, Missouri, announced a field safety corrective action for DEX Ophthalmic Tissue Forceps due to an issue with their instructions for use.
The affected devices are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures, double pouched in tyvek pouches and sold in boxes of 5.
The corrective action covers multiple models, including the 25ga DEX Nano Tapered AWH Forceps, 23ga DEX Maculorhexis Forceps, and others, distributed nationwide and in Peru, Argentina, South Korea, Japan, and France.
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?
12 products
Affected if its UDI-DI, lot code and catalog code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/
- UDI-DI
- 10817489021665
- Catalog code
- DVF4005-25
- Lot code
- M50530
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/
- UDI-DI
- 10817489022136
- Catalog code
- DVF4019-23
- Lot code
- M49267
- M50930
- M51230
- M51587
- M51696
- M49921
- M51128
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/
- UDI-DI
- 10840096205111
- Catalog code
- DVF4014-25-S
- Lot code
- M49277
- M47588
- M47364
- M47363
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/
- UDI-DI
- 10817489022143
- 10840096205135
- 10840096202608
- Catalog code
- DVF4019-25
- Lot code
- M50065
- M50068
- M50069
- M50070
- M50071
- M50422
- M50423
- M50534
- M50536
- M50626
- M50625
- M50676
- M50895
- M50896
- M50675
- M50914
- M51032
- M51070
- M51129
- M51231
- M51326
- M51588
- M49164
- M49268
- M49269
- M49773
- M49772
- M49922
- M50067
- M50066
- M50072
- M50421
- M50420
- M50533
- M50631
- M49923
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/
- UDI-DI
- 10817489025557
- 1081748902557
- 10718489025557
- Catalog code
- DVF4034-27
- Lot code
- M47331
- M48044
- M48163
- M47612
- M48071
- M48164
- M48470
- M48471
- M48043
- M47611
- M48472
- M48658
- M48657
- M49169
- M49170
- M49287
- M49777
- M49776
- M49830
- M49831
- M49907
- M49906
- M49925
- M49926
- M50538
- M50628
- M50629
- M50897
- M50898
- M50678
- M50917
- M50932
- M50993
- M51034
- M51076
- M51077
- M51131
- M51235
- M51236
- M51292
- M51293
- 51329
- M51630
- M51629
- M51699
- M51700
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/
- UDI-DI
- 10817489021658
- Catalog code
- DVF4005-23
- Lot code
- M50529
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/
- UDI-DI
- 10840096205166
- Catalog code
- DVF4034-25-S
- Lot code
- M47337
- M50921
- M51525
- M51526
- M52172
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/
- UDI-DI
- 10817489025540
- Catalog code
- DVF4034-25
- Lot code
- M47116
- M48162
- M48276
- M48303
- M49168
- M49270
- M49285
- M49286
- M49775
- M49829
- M49905
- M50289
- M50208
- M50290
- M50916
- M50992
- M51033
- M51074
- M51075
- M51234
- M51290
- M51291
- M51521
- M51628
- M51698
- M51893
- M52019
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/
- UDI-DI
- 10840096205142
- Catalog code
- DVF4022-25-S
- Lot code
- M51041
- M50093
- M50293
- M50216
- M50431
- M50543
- M50634
- M50903
- M50937
- M50997
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/
- UDI-DI
- 10840096205135
- Catalog code
- DVF4019-25-S
- Lot code
- M50541
- M50542
- M50632
- M50633
- M50936
- M50996
- M51039
- M51040
- M51081
- M51138
- M47122
- M47123
- M47336
- M48308
- M48660
- M49294
- M49784
- M49839
- M49910
- M49929
- M49930
- M50215
- M50427
- M50429
- M50428
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/
- UDI-DI
- 10840096205128
- Catalog code
- DVF4016-25-S
- Lot code
- M48801
- M49278
- M47582
- M48049
- M451038
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/
- UDI-DI
- 10817489022150
- Catalog code
- DVF4019-27
- Lot code
- M50931
- M51130
- M51589
- M52018
- M52195
- M50073
- M50287
- M50677
- M50991
- M51071
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
- Company
- Katalyst Surgical, LLCChesterfield, Missouri
- Hazard
- Device defect
- 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
- 98660
- Recall numbers
- Z-2069-2026 to Z-2080-2026
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
