Boston Scientific Corporation recall records

352 reported ongoing

354 records in this archive. Latest source date Aug 6, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.

Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the g...

Class IIReported ongoing

Distribution: International distribution to the country of Japan only.

Official source for EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
FDA device enforcement

Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products:...

The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.

Class IIReported ongoing

Distribution: Distribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin Islands. There was also government/military distribution. Foreign distribution was made to Andorra,...

Official source for Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model...
FDA device enforcement

EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

Poor image quality due to fluid ingress in the lens.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,...

Official source for EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
FDA device enforcement

EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.

Poor image quality due to fluid ingress in the lens.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,...

Official source for EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M0054242...
FDA device enforcement

Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide cath...
FDA device enforcement

Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide cat...
FDA device enforcement

Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide cat...
FDA device enforcement

Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide cat...
FDA device enforcement

Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide cat...
FDA device enforcement

Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide cat...
FDA device enforcement

Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide cat...
FDA device enforcement

Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide cat...
FDA device enforcement

Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Class IIReported ongoing

Distribution: US Nationwide distribution in the state of Indiana.

Official source for Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide cat...

Reasons in these listed records

  • Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue ...
  • The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
  • Poor image quality due to fluid ingress in the lens.
  • Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These examples come from this result page and are not a ranking of every recall reason.

Checking Boston Scientific Corporation

Is there a recall on boston scientific corporation right now?

This archive contains 354 records, including 352 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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