Device recall: Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software…
Class II FDA enforcement event 98252. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Devices which did not undergo thermoforming could deform and lose performance.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Olympus Corporation of the Americas started this device recall on 7 Jan 2026. The firm address in the FDA record is in Center Valley, PA. FDA put the recall in Class II. FDA event 98252 has 30 product records. The first FDA enforcement report date is 11 Feb 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
Olympus Corporation of the Americas, Center Valley, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
30 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1268-2026 | 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. | 72023 units (3920 US, 68103 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1269-2026 | 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. | 12641 units (8789 US, 3852 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1270-2026 | 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. | 7689 units (7501 US, 188 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1271-2026 | 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. | 33433 units (36 US, 33397 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1272-2026 | 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. | 65117 units (9707 US, 55410 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1273-2026 | 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. | 136037 units (9959 US, 126078 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1274-2026 | 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. | 86303 units (1803 US, 84500 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1275-2026 | 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. | 30489 units (11779 US, 18710 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1276-2026 | 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. | 17655 units (2411 US, 15244 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1277-2026 | 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. | 4183 units (821 US, 3362 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1278-2026 | 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. | 10008 units (3038 US, 6970 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1279-2026 | 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. | 10257 units (274 US, 9983 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1280-2026 | 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. | 5946 units (2208 US, 3738 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1281-2026 | 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. | 5089 units (30 US, 5059 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1282-2026 | 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. | 1918 units (413 US, 1505 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1283-2026 | 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. | 1504 units (350 US, 1154 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1284-2026 | 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. | 93 units (5 US, 88 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1285-2026 | 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. | 125 units (7 US, 118 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1286-2026 | 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. | 887 units (650 US, 237 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1287-2026 | 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. | 886 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1288-2026 | 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. | 1072 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1289-2026 | 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. | 1490 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1290-2026 | 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. | 3954 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1291-2026 | 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. | 7046 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1292-2026 | 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. | 2344 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1293-2026 | 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. | 999 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1294-2026 | 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. | 1980 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1295-2026 | 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. | 650 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1296-2026 | 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. | 1025 units (OUS only) | Class II | Ongoing | 11 Feb 2026 |
| Z-1297-2026 | 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. | 1474 units (all OUS) | Class II | Ongoing | 11 Feb 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 30Median of the firm: 1
- Events of the firm on the register
- 141
Other events of the firm
Official channels
- FDA enforcement report Z-1268-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 98252. https://recallregister.com/fda/ii/98252/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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,…
- What quantity of product is in FDA event 98252?
- The event has 30 product records. The first record gives this quantity:
72023 units (3920 US, 68103 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.