Z-1294-2026Class II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description...
OLYMPUS Corporation of the Americas / initiated 2026-01-07 / Open, Classified / root cause: manufacturing process
Olympus Corporation of the Americas began a recall of Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used... on . FDA classified it as Class II and gives the reason as "Devices which did not undergo thermoforming could deform and lose performance". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1294-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- OLYMPUS Corporation of the Americas
- Product
- 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.
- Product code
- KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Reason for recall
- Devices which did not undergo thermoforming could deform and lose performance.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- On or around January 7, 2026, URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: the following actions: 1. Examine your inventory and quarantine any identified devices immediately. 2. Immediately cease usage of any affected product in your inventory. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. Olympus will issue a credit to your facility upon receipt of your affected product. 4. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0487 c. Complete the form as instructed. 5. If you have further distributed it, please forward this notice to other users who may have the affected products. Olympus requests you to report any complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me at [email protected] or by phone at (647) 999-3203.
- Quantity in commerce
- 1980 units (OUS only)
- 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, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.
- Product codes and lots
- Model/Catalog Number: KD-401Q-0725; Material REF: 5856930; UDI-DI: 04953170041587; All Lots with a valid expiration date
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1268-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1269-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1270-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1271-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1272-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1273-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1274-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1275-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1276-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1277-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1278-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1279-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1280-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1281-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1282-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1283-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1284-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1285-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1286-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1287-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1288-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1289-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1290-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1291-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1292-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1293-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1294-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1295-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1296-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1297-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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