The Recall Desk
HighFDA (Devices)·Z-2522-2023·Announced 2023-09-13

Olympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels

Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with documented chemical hazard (DEHP exceeding permissible exposure levels per ISO 10993-17: 2002). This constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criterion.

Plain-English summary

Aomori Olympus Co., Ltd. is recalling 1,048 units of the Olympus Distal Attachment, a component of Olympus Disposable EMR Kits (models K-001, K-002, K-003, K-004, K-011, and K-012). The product is designed to be attached to the distal end of endoscopes and was distributed nationwide in the United States.

The distal attachment contains di-2-ethylhexyl phthalate (DEHP) at levels exceeding the permissible exposure limit as established in ISO 10993-17: 2002, a standard for biological hazard evaluation of medical devices.

Affected devices are identified by specific lot numbers assigned to each kit model. K-001 lot numbers include 5835330 with variant codes 0XI, 0YI, 12I, 14I, 15I, 16I, 17I, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K (UDI: 4953170048562). Specific lot numbers and UDI codes for other models (K-002 through K-012) are available in the detailed recall information.

The recalled product

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
Manufacturer
Aomori Olympus Co., Ltd.
Category
Medical Device — Endoscopic Equipment
Hazard
  • dehp
  • chemical-exposure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (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
  • 13I
  • 2ZK 4953170048579 K-003 5835530 0XI
  • 25K
  • 2ZK UDI:4953170048586 (3)K-004 Lot Numbers: 5835630 16I

Distribution

Distributed nationwide across the United States.

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