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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Boston Scientific Corporation: Capio SLIM Suture Capturing Device Recalled for Failure to Secure Sutures

Agency Publication Date: July 30, 2024
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Summary

Boston Scientific Corporation is recalling approximately 141,780 Capio SLIM Suture Capturing Devices because certain lots may not consistently catch the suture after the device is activated. These surgical tools are used by physicians during open surgeries to place stitches, and a failure to capture the suture can lead to longer surgery times or the need for additional medical interventions. Consumers who have undergone surgery involving these devices should consult their healthcare provider if they have concerns.

Risk

The device may fail to secure the suture during a surgical procedure, which can lead to delays while the surgeon attempts to correct the issue or potentially require additional medical procedures to ensure the stitches are placed correctly.

What You Should Do

  1. Check your medical records or contact your healthcare provider to determine if a Capio SLIM Suture Capturing Device was used during your procedure.
  2. For medical facilities, identify the 5-pack boxes (UPN M0068318261 / UDI 08714729842224) or individual packs (UPN M0068318260 / UDI 08714729842804) by checking for affected lot numbers including 30110296, 30110298, 30254839, 31248068, 33815834, and many others listed in the recall notice.
  3. For medical facilities, identify the 1-pack variant (UPN M0068318250 / UDI 08714729838005) by checking for lot numbers such as 29729168, 30362314, 31876917, and 33817740.
  4. If you are a healthcare provider or facility, immediately stop using the affected lots and contact Boston Scientific Corporation at 100 Boston Scientific Way, Marlborough, MA 01752 for instructions on returning the product.
  5. Contact your healthcare provider or the manufacturer for further instructions and potential refund regarding these devices.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Capio SLIM Suture Capturing Device (Pack of 5)
Model / REF:
M0068318261 (Outer Package)
M0068318260 (Inner Package)
Z-2451-2024
UPC Codes:
08714729842224
08714729842804
Lot Numbers (113):
30110296
30110298
30254839
30269668
30277679
30340398
30348745
30361515
30369786
30477997
30485719
30502470
30509859
30566414
30571306
30579075
30594738
30597768
30601523
30601525
30608273
30621482
30622202
30628533
30642670
30671135
30825890
30834186
30849605
30853891
30862718
30870581
30877151
30880729
31248068
31305827
31316815
31324676
31400076
31442842
31459986
31475463
31479225
31488049
31494812
31502318
31509747
31514250
31583783
31592632
Product: Capio SLIM Suture Capturing Device (1-Pack)
Model / REF:
M0068318250
Z-2452-2024
UPC Codes:
08714729838005
Lot Numbers (61):
29729168
29729169
29972338
30110291
30110294
30254836
30254837
30331858
30338212
30362314
30367934
30434163
30437947
30551935
30598976
30842709
30860944
30993213
30997334
31005909
31257604
31292169
31352417
31367044
31535491
31544821
31554784
31574100
31574101
31624545
31638194
31648501
31727288
31755722
31856165
31856166
31876917
31876918
31876919
31942747
31942748
31984730
32016719
32085084
32259390
32267863
32664886
32699058
32725350
32812025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94921
Status: Active
Manufacturer: Boston Scientific Corporation
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 2 products (70,890 units total)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.