Z-2522-2023Class II

Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the...

Name: Z-2522-2023 Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the...
Creator: Aomori Olympus Co., Ltd.
Published: 2023-07-27
License: https://open.fda.gov/license/

AOMORI OLYMPUS CO., Ltd. Kuroishi Site / initiated 2023-07-27 / Open, Classified / root cause: manufacturing process

FDA source

Aomori Olympus Co., Ltd. began a recall of Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003... on 2023-07-27. FDA classified it as Class II and gives the reason as "The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2522-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-27
Posted: 2023-09-07
Recalling firm: AOMORI OLYMPUS CO., Ltd. Kuroishi Site
Product: Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Product code: FDS Gastroscope And Accessories, Flexible/Rigid
Reason for recall: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Olympus issued Urgent Medical Device Recall Letter dated July 27, 2023 to ENDOSCOPY DEPARTMENT, RISK MANAGEMENT. Letter states reason for recall, health risk and action to take: Immediately assess any product you have to identify the product number with affected lot listed in this communication, cease use and quarantine any affected products. The image below depicts the area where the lot number is identified. The lot# is on the Carton box and Pack. Please refer to Attachment 2 for the identification of the subject products. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility for your affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0429 4. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including patient physical condition suspected to be affected by DEHP, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). If you require additional information, please contact Tara Safi, Field Corrective Actions Administrator at [email protected].
Quantity in commerce: 1,048 units
Distribution: US Nationwide distribution.
Product codes and lots: (1)K-001: Lot Numbers: 5835330 0XI, 0YI, 12I, 14I, 15I, 16I, 17I, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K. UDI: 4953170048562 (2) K-002 Lot Numbers: 5835430 0XI, 0YI, 12I, 13I, 14I, 16I, 17I, 27K, 2XK, 2YK, 2ZK 4953170048579 K-003 5835530 0XI, 0YI, 12I, 13I, 14I, 15I, 16I, 17I, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK UDI:4953170048586 (3)K-004 Lot Numbers: 5835630 16I, 17I, 26K UDI: 4953170048593 (4)K-011 Lot Numbers: N2485230 0XI, 15I, 17I UDI: 4953170214035 (5) K-012 Lot Numbers: N2485330 16I, 17I UDI: 4953170214042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2522-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2522-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-13	2023-09-07
Z-2523-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-13	2023-09-07

Product code FDS

K984358Class IIOlympus Distal Attachment, Models Mh-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597Olympus America, Inc. / cleared 1999-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)