CLASS II ONGOING Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

Flexible DCI Intubation Fiberscope, Part: 11302BDD2 recalled

Karl Storz Endoscopy is recalling Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US, distributed nationwide in the US. The recall was initiated on 27 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesInstruction Manual Version: 08/2018

Quantity recalled428

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2895-2020
FDA event ID: 86009
Recalling firm: Karl Storz Endoscopy, El Segundo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jul 2020
FDA classified: 27 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Masks, Gloves & PPE

Timeline

27 Jul 2020	Recall initiated by company
27 Aug 2020	Classified by FDA	+31 days
2 Sep 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of CA, NY, PA, AZ, OH, NJ, FL, NC, IL, SC, MA, IA, ND, WI, UT, AR, GA, WA, KY, CO, TX, TN, AL, LA, NE, WV, MO, MN, VA, MT, CT, MI, IN, NM, NV, ME, VT, NH, WY, DC, DE, OR, OK, MD, ID, AK, MS, KS, HI, RI, SD and the country of Canada.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

Instruction Manual Version: 08/2018

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 86009

This product is part of a recall event; the main page for the event is Flexible Intubation Fiberscope, Part: 11301BN1 recalled.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2020	CLASS II	Flexible Intubation Fiberscope, Part: 11301BN1 recalled	Karl Storz Endoscopy	Sterility	Nationwide
2 Sep 2020	CLASS II	Flexible Intubation Fiberscope, Part: 11301AA1 recalled	Karl Storz Endoscopy	Sterility	Nationwide
2 Sep 2020	CLASS II	Flexible Intubation Fiberscope, Part: 11302BD2 recalled	Karl Storz Endoscopy	Sterility	Nationwide
2 Sep 2020	CLASS II	Flexible Intubation Video Endoscope, Part: 11303BNX recalled	Karl Storz Endoscopy	Sterility	Nationwide
2 Sep 2020	CLASS II	Flexible Intubation Video Endoscope, Part: 11302BDX recalled	Karl Storz Endoscopy	Sterility	Nationwide
2 Sep 2020	CLASS II	Flexible DCI Intubation Fiberscope, Part: 11301BND1 recalled	Karl Storz Endoscopy	Sterility	Nationwide
2 Sep 2020	CLASS II	Flexible Intubation Video Endoscope, Part: 11301BNX recalled	Karl Storz Endoscopy	Sterility	Nationwide

More recalls from Karl Storz Endoscopy

All 71

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Flexible Hystero-Fiberscope Kits recalled by Karl Storz Endoscopy	Karl Storz Endoscopy	Sterility	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide

Other Masks, Gloves & PPE recalls

All 447

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Adapter for Head Positioning recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
3 Jun 2026Device	CLASS II	Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled	O&M Halyard	Other	Nationwide