FDA Medical Device Recalls (openFDA)
Aomori Olympus Co., Ltd.: NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
- Recall number
- Z-1030-2021
- Recalling firm
- Aomori Olympus Co., Ltd.
- Product
- NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
- Status
- Terminated
- Initiated
- 2021-01-04
- Posted
- not on file
- Terminated
- 2024-03-11
- Reason
- Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Root cause
- Under Investigation by firm
- Action
- On January 4, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the identified list of Endo-therapy devices may have a defective seal which may compromise the sterility of the product. Customers were asked to take the following actions: 1. Immediately assess any product you have in stock to identify endotherapy products with affected lot numbers listed in the recall letter. Cease use of product and quarantine any affected product. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit or replacement to your facility for any returned product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0391 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
- Quantity
- 7,400,000 (globally); 260,395 (US)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 03K, 04K, 08K, 05V, 06V, 07V, 08V, 09V, 0XV
- 510(k) numbers
- ["K153625"]
- PMA numbers
- not on file
- Product code
- FBK
- Firm FEI
- 3003995201
- Firm city
- Kuroishi
- Firm state
- 2 Chome
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28