FDA recall, , Moderate risk
Boston Scientific Rapid Refill Continuous Injection System
The Rapid Refill Continuous Injection System contains a syringe that may loosen or disconnect, causing fluid leakage or separation.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation, located in Marlborough, Massachusetts, began a recall on June 30, 2026, of the Rapid Refill Continuous Injection System, UPN M00566001. The device contains a recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of the syringe loosening or disconnecting from the manifold, resulting in a loose connection or complete disconnection.
This may lead to difficulty connecting the syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
The recall was added to the FDA's Enforcement Report and classified by the FDA on July 10, 2026, and was in the FDA's weekly enforcement report on July 22, 2026. The distribution is US nationwide, with an OUS consignee list pending.
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 and lot code are listed under that product.
Incomplete list: 40 of 299 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Rapid Refill Continuous Injection System, UPN M00566001
- UDI-DI
- 08714729285151
- 33786611
- 33825949
- 33826026
- 33949916
- 33968571
- 33968575
- 34079981
- 34153104
- 34153413
- 34153415
- 34203075
- 34203077
- 34153411
- 34203079
- 34203115
- 34386605
- 34386609
- 34386613
- 34429656
- 34429658
- 34595249
- 34693559
- 34616613
- 34616615
- 34712433
- 34763427
- 34763967
- 34805723
- 34805725
- 34805729
- 35006995
- 35006999
- 35056793
- 35208946
- 35186845
- 35208950
- 35397314
- 35208952
- 35305436
- 35498030
- 35448316
- 35498028
- 35551523
- 35626939
- 35574463
- 35688118
- 35688460
- 35828714
- 35831703
- 35848483
- 35877768
- 35995282
- 36049415
- 36159194
- 36219882
- 36294100
- 36303614
- 36332230
- 31177006
- 31180206
- 31666278
- 31329922
- 31356107
- 31666276
- 31798400
- 31798133
- 31798135
- 31798137
- 31852246
- 32162450
- 32208753
- 32255526
- 32255528
- 32496142
- 32661870
- 32696046
- 32696050
- 32696052
- 32752697
- 32773682
- 32791475
- 32791477
- 32820865
- 32838612
- 32791479
- 33119798
- 32977346
- 32977348
- 33030942
- 33120320
- 33158008
- 33158006
- 33354311
- 33354315
- 33354317
- 33403248
- 33403252
- 33696882
- 33696884
- 33696886
- 33696888
- 33750883
- 33750885
- 33750887
- 36332232
- 36497262
- 36159192
- 36587704
- 36612263
- 36739668
- 36785215
- 36785217
- 36814560
- 36845486
- 36983883
- 36983886
- 37291592
- 37059471
- 37417957
- 37417959
- 37429808
- 37456936
- 37472523
- 37585745
- 37627037
- 37654892
- 37941477
- 37974508
- 38033021
- 38033023
- 38124799
- 38143635
- 38165214
- 38182214
- 38201123
- 37959187
- 38353956
- 38374833
- 38430201
- 33968573
- 34386611
- 32838610
- 38205377
- 38429054
- 34066207
- 34429654
- 34616611
- 34712429
- 34763971
- 34805727
- 35006997
- 35448312
- 35448314
- 35626937
- 35688021
- 35848481
- 35687399
- 31616842
- 31601573
- 31616848
- 31616850
- 31616846
- 32208755
- 32455154
- 35877766
- 36776858
- 37037796
- 37200706
- 37276220
- 37291594
- 37639238
- 38154387
- 35305438
- 31797614
- 33354313
- 33696890
- 36470789
- 37309672
- 37396601
- 37407323
- 37472521
- 35056797
- 35626933
- 33786613
- 33825951
- 33950422
- 34965218
- 35056795
- 36101020
- 36100418
- 31356105
- 32208759
- 32661868
- 33030940
- 33679650
- 37059473
- 37041524
- 37633157
- 37991645
- 38137850
- 38393609
- 33968569
- 34703963
- 36319481
- 33649863
- 37019542
- 37493275
- 34616609
- 34386607
- 34763969
- 34805721
- 35942747
- 31852244
- 32977350
- 33354319
- 37884043
- 38001944
- 32752695
- 37189280
- 37612931
- 38703180
- 34429700
- 33968567
- 34017321
- 34568306
- 34712431
- 34873735
- 34873737
- 34965420
- 35007081
- 35186843
- 35208948
- 35397312
- 35448310
- 35305600
- 35626935
- 35778515
- 35778517
- 35778513
- 35989120
- 36027670
- 36049413
- 36303612
- 36319483
- 36312073
- 36353951
- 36437019
- 36517931
- 36409546
- 36537384
- 36622267
- 36750117
- 36750119
- 36994750
- 36962014
- 37407325
- 37456934
- 37766480
- 37660978
- 37764898
- 37723376
- 37991643
- 38856580
- 38178214
- 38337853
- 38326961
- 38410111
- 38414293
- 38576233
- 38586789
- 38622115
- 38633220
- 38676778
- 38649491
- 38680582
- 38864691
- 38687308
- 38876174
- 38901702
- 31170922
- 31601571
- 31616844
- 31852242
- 31852240
- 32162448
- 32208757
- 32696048
- 32723872
- 32723874
- 32838608
- 32964550
- 32977344
- 33119794
- 33119796
- 33257466
- 33334705
- 33403250
- 33649865
- 33933383
- Lot code
- 33786611
- 33825949
- 33826026
- 33949916
- 33968571
- 33968575
- 34079981
- 34153104
- 34153413
- 34153415
- 34203075
- 34203077
- 34153411
- 34203079
- 34203115
- 34386605
- 34386609
- 34386613
- 34429656
- 34429658
- 34595249
- 34693559
- 34616613
- 34616615
- 34712433
- 34763427
- 34763967
- 34805723
- 34805725
- 34805729
- 35006995
- 35006999
- 35056793
- 35208946
- 35186845
- 35208950
- 35397314
- 35208952
- 35305436
- 35498030
Recall details
- Company began the recall
- Sold in
US Nationwide distribution. OUS consignee list pending.
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- 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
- 99336
- Recall number
- Z-2725-2026
All recalls from Boston Scientific Corporation
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
