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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98252

30 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 07, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

30 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 30

Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1268-2026
Recall number
Z-1268-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
72023 units (3920 US, 68103 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-0320; Material REF: (1) N1089430, (2) N1089410, (3) N5411130; UDI-DI: (1) 04953170183973, (2) 04953170466274, (3) 04953170380556; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 2 of 30

Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1269-2026
Recall number
Z-1269-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
12641 units (8789 US, 3852 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC431Q-0720; Material REF: (1) N5391530, (2) N5391510, (3) N5777830; UDI-DI: (1) 04953170466427, (2) 04953170466427, (3) 04953170466427; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 3 of 30

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1270-2026
Recall number
Z-1270-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
7689 units (7501 US, 188 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-431Q-0720; Material REF: (1) 5859230, (2) N6221831, (3) N6221840; UDI-DI: (1) 04953170042362, (2) 04953170463778, (3) 04953170466564; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 4 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1271-2026
Recall number
Z-1271-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
33433 units (36 US, 33397 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-0330; Material REF: (1) N1089530, (2) N1089510, (3) N5411230; UDI-DI: (1) 04953170380563, (2) 04953170380563, (3) 04953170380563; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 5 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1272-2026
Recall number
Z-1272-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
65117 units (9707 US, 55410 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-0720; Material REF: (1) N1089610, (2) N5411330; UDI-DI: (1) 04953170184017, (2) 04953170380570; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 6 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1273-2026
Recall number
Z-1273-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
136037 units (9959 US, 126078 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-0725; Material REF: (1) N1089710, (2) N5411430; UDI-DI: (1) 04953170380587, (2) 04953170380587; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 7 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1274-2026
Recall number
Z-1274-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
86303 units (1803 US, 84500 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-0730; Material REF: (1) N1089810, (2) N5411530; UDI-DI: (1) 04953170380594, (2) 04953170380594; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 8 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1275-2026
Recall number
Z-1275-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
30489 units (11779 US, 18710 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V431M-0720; Material REF: (1) N1090410, (2) N1090430, (3) N5411930; UDI-DI: (1) 04953170184178, (2) 04953170184178, (3) 04953170184178; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 9 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1276-2026
Recall number
Z-1276-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
17655 units (2411 US, 15244 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V431M-0730; Material REF: (1) N1090530, (2) N1090510, (3) N5412030; UDI-DI: (1) 04953170380648, (2) 04953170380648, (3) 04953170380648; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 10 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1277-2026
Recall number
Z-1277-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
4183 units (821 US, 3362 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC431Q-0730; Material REF: (1) N5391610, (2) N5391630, (3) N5777930; UDI-DI: (1) 04953170466434, (2) 04953170466434, (3) 04953170466434; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 11 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1278-2026
Recall number
Z-1278-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
10008 units (3038 US, 6970 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC411Q-0720; Material REF: (1) N5391210, (2) N5391230, (3) N5777530; UDI-DI: (1) 04953170371110, (2) 04953170371110, (3) 04953170371110; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 12 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1279-2026
Recall number
Z-1279-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
10257 units (274 US, 9983 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC411Q-0730; Material REF: (1) N5391330, (2) N5391310, (3) N5777630; UDI-DI: (1) 04953170399329, (2) 04953170399329, (3) 04953170399329; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 13 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1280-2026
Recall number
Z-1280-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
5946 units (2208 US, 3738 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC411Q-0320; Material REF: (1) N5391030, (2) N5391010, (3) N5777330; UDI-DI: (1) 04953170466403, (2) 04953170466403, (3) 04953170466403; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 14 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1281-2026
Recall number
Z-1281-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
5089 units (30 US, 5059 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC411Q-0330; Material REF: (1) N5391130, (2) N5391110, (3) N5777430; UDI-DI: (1) 04953170371097, (2) 04953170371097, (3) 04953170371097; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 15 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1282-2026
Recall number
Z-1282-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
1918 units (413 US, 1505 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC412Q-0215; Material REF: (1) N5391410, (2) N5391430, (3) N5777730; UDI-DI: (1) 04953170371158, (2) 04953170371158, (3) 04953170371158; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 16 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1283-2026
Recall number
Z-1283-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
1504 units (350 US, 1154 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC433Q-0720; Material REF: (1) N5391710, (2) N5391730, (3) N5778030; UDI-DI: (1) 04953170371219, (2) 04953170371219, (3) 04953170371219; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 17 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1284-2026
Recall number
Z-1284-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
93 units (5 US, 88 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC433Q-0730; Material REF: (1) N5391830, (2) N5391810, (3) N5778130; UDI-DI: (1) 04953170371233, (2) 04953170371233, (3) 04953170371233; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 18 of 30

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1285-2026
Recall number
Z-1285-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
125 units (7 US, 118 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-411Q-0720; Material REF: 5858030; UDI-DI: Under Review; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 19 of 30

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1286-2026
Recall number
Z-1286-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
887 units (650 US, 237 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-411Q-0730; Material REFs: (1) 5858230, (2) N6221731, (3) N6221740; UDI-DI: (1)04953170466557, (2)04953170466557, (3)04953170466557; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 20 of 30

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1287-2026
Recall number
Z-1287-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
886 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-401Q-0330; Material REF: 5856730; UDI-DI: 04953170041617; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 21 of 30

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1288-2026
Recall number
Z-1288-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
1072 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-401Q-0720; Material REF: 5856830; UDI-DI: 04953170041648; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 22 of 30

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1289-2026
Recall number
Z-1289-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
1490 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-401Q-0730; Material REF: 5857030; UDI-DI: 04953170041709; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 23 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1290-2026
Recall number
Z-1290-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
3954 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-1520; Material REF: (1) N5411630, (2) N1089910; UDI-DI: (1)04953170380600, (2) N/A; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 24 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1291-2026
Recall number
Z-1291-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
7046 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-1530; Material REF: (1) N5411730, (2) N1090010; UDI-DI: (1)04953170380617, (2)N/A; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 25 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1292-2026
Recall number
Z-1292-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
2344 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-3030; Material REF: (1) N5411830, (2) N1090310; UDI-DI: (1)04953170184154, (2)N/A; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 26 of 30

Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1293-2026
Recall number
Z-1293-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
999 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-401Q-0320; Material REF: 5856630; UDI-DI: 04953170041587; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 27 of 30

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1294-2026
Recall number
Z-1294-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
1980 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-401Q-0725; Material REF: 5856930; UDI-DI: 04953170041587; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 28 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1295-2026
Recall number
Z-1295-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
650 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-3020; Material REF: N1090110; UDI-DI: N/A; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 29 of 30

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1296-2026
Recall number
Z-1296-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
1025 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-V411M-3025; Material REF: N1090210; UDI-DI: N/A; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

device · product 30 of 30

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Z-1297-2026
Recall number
Z-1297-2026
Initiated
January 07, 2026
Classification
Class II
Status
Ongoing
Quantity
1474 units (all OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices which did not undergo thermoforming could deform and lose performance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not undergo thermoforming could deform and lose performance.

Code information

Model/Catalog Number: KD-VC411Q-0725; Material REF: N5424710; UDI-DI: N/A; All Lots with a valid expiration date

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.