Lower risk Medical device recall · FDA · Published July 27, 2023

Olympus Distal Attachment Recall: DEHP Chemical Risk in Disposable EMR Kits

Olympus recalls disposable EMR kits with distal attachments containing DEHP that exceeds safe exposure levels per ISO 10993-17:2002. Affected kits include specific model numbers and lot ranges.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2522-2023Medical device Olympus ›

Lower-risk recall

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

Take action

Contact the company

Recalling firmAomori Olympus Co., Ltd.2 Chome 248-1, Okkonoki · Kuroishi, Japan

✎ GovInfoNow plain-language explainer

Olympus is recalling certain disposable EMR kits that include a distal attachment. The attachment contains di-2-ethylhexyl phthalate (DEHP), a chemical that exceeds safe exposure levels as defined by international safety standards. This could pose a health risk with prolonged exposure, though the recall does not specify immediate harm. Read more at govinfonow.com/recall/57578-olympus-distal-attachment-recall-dehp-chemical-risk-in-disposable-emr.

Source Summary by GovInfoNow · govinfonow.com/recall/57578-olympus-distal-attachment-recall-dehp-chemical-risk-in-disposable-emr · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2522-2023

Cite this page

“Olympus Distal Attachment Recall: DEHP Chemical Risk in Disposable EMR Kits.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57578-olympus-distal-attachment-recall-dehp-chemical-risk-in-disposable-emr. Based on FDA recall #Z-2522-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2522-2023%22&limit=1).

Aomori Olympus Co., Ltd. recalled the Olympus Distal Attachment in its Disposable EMR Kit due to DEHP exceeding permissible exposure levels, according to the FDA on July 27, 2023.

How to tell if you have it

Brand: Olympus
Product: Olympus Distal Attachment (in Olympus Disposable EMR Kit)
Disposable EMR Kit models: K-001, K-002, K-003, K-004, K-011, K-012
Units affected: 1,048

The hazard

The Distal Attachment contains di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002, according to the FDA.

Context

GovInfoNow's records show Aomori Olympus Co., Ltd. has one other recall on record since Jan. 4, 2021, involving an Olympus INJECTOR FORCEMAX with a risk of infection from poor seals. Other recent recalls of similar products include Olymp Single Use Distal Cover (June 5, 2026) and Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes (March 25, 2026).

How to tell if you have this one

Check if your Olympus Disposable EMR Kit includes model numbers K-001, K-002, K-003, K-004, or K-012. Look for specific lot numbers and UDI codes listed in the recall notice.

Brand
Olympus
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-2522-2023	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; (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	1,048 units
Z-2523-2023	Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666; Model: UDI: MH-462 4953170047732 MH-463 4953170047756 MH-464 4953170047770 MH-465 4953170047794 MH-466 4953170047817 MH-483 N/A MH-587 4953170047855 MH-588 4953170364518 (US) MH-589 4953170047893 MH-590 N/A MH-591 4953170047930 MH-592 N/A MH-593 4953170047978 MH-594 4953170047992 MH-595 4953170048012 MH-596 N/A MH-597 4953170048050 MH-598 N/A MAJ-289 N/A MAJ-290 N/A MAJ-291 N/A MAJ-292 N/A MAJ-293 N/A MAJ-294 N/A MAJ-295 N/A MAJ-296 N/A MAJ-297 N/A MAJ-663 N/A MAJ-664 N/A MAJ-665 N/A MAJ-666 N/A DIstal Attachment- All lots	1,252 units

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Identify your Olympus Disposable EMR Kit model and lot numbers to confirm if it is affected by this recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 48 days after the firm started it.

Jul 27, 2023Firm started the recall
Sep 7, 2023FDA classified it Class II
Sep 13, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57578-olympus-distal-attachment-recall-dehp-chemical-risk-in-disposable-emr">Olympus Distal Attachment Recall: DEHP Chemical Risk in Disposable EMR Kits (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2522-2023 (July 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2522-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.