FDA recall, , Moderate risk
Intuitive Surgical Da Vinci PSS SP1098
The Da Vinci Assy, PSS, SP1098 may have a retainer pin issue that can cause uncontrolled motion.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc., of Sunnyvale, California, began a recall on April 22, 2026, for the Da Vinci ASSY, PSS, SP1098. The operative components of the surgical system may have been distributed with an E-brake retainer pin that, in the event of a structural column failure, would prevent E-brake engagement and may result in uncontrolled motion.
Additionally, if the pin moves or backs out, it may cause restricted column range of motion and/or uncontrolled motion, which may lead to patient tissue injury, crushing injury, or bleeding.
The recall was added to the FDA's Enforcement Report and classified on June 22, 2026, with distribution worldwide, including nationwide in the U.S. across 38 states and in countries such as Belgium, Japan, Germany, and the United Kingdom. For those with the product, the potential for uncontrolled motion may cause injury.
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?
Match the UDI-DI and part code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Da Vinci Assy, PSS, SP1098
- UDI-DI
- 00886874114605
- 10008062
- 10211920
- 10003059
- 10009706
- 10003509
- 10003510
- 10009707
- 10065786
- 10020729
- 10012963
- 10020705
- 10031145
- 10031144
- 10012962
- 10036960
- 10711066
- 10035476
- 10043635
- 10072852
- 10072853
- 10069899
- 10076490
- 10087446
- 10054478
- 10080929
- 10130089
- 10165287
- 10180162
- 10172589
- 10103483
- 10103484
- 10056518
- 10092007
- 10246370
- 10209961
- 10183740
- 10232634
- 10231116
- 10211880
- 10194911
- 10245457
- 10112470
- 10189443
- 10238314
- 10644376
- 10036961
- 10274101
- 10112471
- 10238315
- 10172574
- 10281524
- 10278366
- 10252751
- 10289629
- 10293276
- 10261900
- 10274102
- 10285085
- 10281525
- 10243796
- 10267796
- 10278365
- 10285084
- 10308532
- 10318311
- 10293274
- 10323177
- 10322512
- 10289630
- 10326939
- 10293275
- 10333333
- 10326938
- 10492299
- 10302474
- 10302473
- 10368392
- 10332310
- 10346946
- 10354749
- 10346943
- 10333332
- 10346942
- 10267795
- 10323178
- 10295600
- 10223509
- 10252780
- 10396330
- 10263730
- 10354748
- 10337879
- 10265272
- 10354750
- 10384455
- 10359960
- 10368393
- 10366206
- 10375031
- 10363897
- 10396329
- 10363898
- 10375032
- 10375033
- 10409934
- 10401560
- 10409933
- 10408268
- 10294693
- 10408269
- 10396331
- 10480883
- 10499186
- 10499185
- 10384456
- 10502598
- 10495654
- 10502599
- 10505838
- 10512168
- 10512167
- 10512166
- 10508290
- 10368391
- 10556776
- 10417803
- 10526733
- 10417164
- 10508289
- 10384454
- 10492298
- 10480878
- 10526735
- 10526736
- 10537191
- 10495655
- 10526734
- 10526732
- 10537202
- 10568118
- 10308533
- 10547839
- 10564979
- 10550219
- 10564978
- 10550220
- 10550221
- 10561240
- 10594744
- 10575228
- 10571615
- 10575229
- 10583123
- 10571614
- 10556769
- 10583124
- 10594746
- 10556777
- 10564977
- 10594743
- 10579531
- 10613173
- 10568117
- 10571616
- 10615325
- 10583126
- 10619701
- 10594742
- 10541679
- 10579530
- 10561239
- 10594745
- 10615326
- 10590323
- 10590322
- 10583125
- 10615941
- 10608089
- 10644375
- 10604955
- 10561241
- 10624252
- 10647203
- 10670710
- 10672825
- 10624990
- 10295599
- 10633489
- 10622883
- 10647201
- 10624251
- 10686903
- 10612973
- 10619702
- 10672839
- 10696000
- 10615940
- 10659191
- 10651445
- 10651443
- 10682596
- 10702363
- 10644374
- 10653815
- 10651444
- 10627633
- 10686902
- 10672840
- 10627632
- 10695999
- 10665125
- 10604956
- 10480877
- 10682597
- 10694981
- 10633487
- 10716881
- 10659189
- 10728578
- 10627631
- 10702364
- 10734551
- 10659190
- 10633488
- 10734552
- 10706206
- 10744259
- 10706207
- 10766233
- 10766236
- 10793380
- 10759158
- 10759159
- 10759161
- 10763608
- 10763609
- 10808841
- 10766234
- 10763611
- 10741377
- 10759160
- 10763610
- 10826493
- 10776325
- 10766235
- 10741378
- 10744258
- 10734553
- 10808839
- 10808840
- 10771126
- 10803470
- 10793379
- 10817400
- 10798922
- 10803484
- 10766232
- 10887260
- 10830719
- 10771125
- 10776323
- 10815457
- 10744257
- 10823000
- 10776324
- 10782092
- 10873054
- 10879012
- 10897582
- 10856718
- 10889592
- 10864698
- 10922820
- 10912617
- 10647204
- 10869722
- 10889594
- 10871773
- 10845441
- 10859690
- 10826495
- 10579532
- 10782090
- 10826494
- 10792831
- 10883203
- 10871774
- 10856716
- 10856732
- 10859689
- 10947466
- 10798915
- 10968849
- 10952495
- 10957321
- 10875232
- 10903586
- 10927370
- 10947464
- 10951328
- 10981839
- 10787962
- 10908841
- 10908842
- 10817401
- 10938311
- 10933815
- 10938312
- 10955031
- 10927371
- 10933816
- 10998396
- 10927372
- 10240354
- 10998395
- 11004904
- 10979952
- 10875231
- 10912618
- 10897581
- 10938310
- 10991256
- 10991257
- 10991259
- 10895278
- 10883202
- 10889593
- 10912619
- 11016764
- 11013103
- Part code
- 380601
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of California, Georgia, Ohio, Pennsylvania, New York, Minnesota, Tennessee, Oregon, Illinois, Maryland, New Jersey, Alabama, Nevada, Texas, Florida, Louisiana, Connecticut, North Carolina, Arizona, Iowa, Missouri, Washington, Michigan, West Virginia, Wisconsin, Kentucky, Kansas, Virginia, Oklahoma, Massachusetts, Indiana, Colorado, South Carolina, South Dakota, Mississippi, New Hampshire, Utah, Maine and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania.
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- 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
- 98701
- Recall number
- Z-2521-2026
All recalls from Intuitive Surgical, Inc.
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
