DSD Application Guide (MG04-0001 revision M) for the Pentax… recallZ-2213-2010 · Minntech Corp · initiated Jun 15, 2010
Terminated All recalls posted in August 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Minntech Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinte
FDA root cause category: Labeling False and Misleading
What the company is doing
Consignees were sent a Medivators Reprocessing Systems "Urgent Medical Device Recall" letter date June 17, 2010. The letter was addressed to "Dear Medivators Customers". The letter described the problem and product involved. Recommended consignees to immediately examine the Pentax EG-3630U Ultrasound Endoscope hookups and inform all staff of the notice to ensure that the DSD-11--HU01109 is not used with the Pentax endoscope. Also requested consignees to complete and return the enclosed response form.
Recall details
- Recall number
- Z-2213-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 15, 2010
- Posted by the FDA
- Aug 12, 2010
- Recalling firm
- Minntech Corp
- Quantity
- 185
- Product code
- FEB
- FDA submissions
- K914145
- Distribution
- AZ, AR, CA, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, PA, SC, TN, TX, UT, VA, WA, WV, WI, WY.
Product description
DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.
Code information (models, lots, serial numbers)
A lot number listing is not applicable as this is a field correction of the labeling. The 0109 hookup itself is not defective and can still be used safely with other enodscopes.
Other devices under the same FDA submission
3 devices cleared under K914145 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medivators HookupMedivators Inc. · Accessories, cleaning, for endoscope1 recall0 reports
- DSD-201 DSD-201 120VMedivators Inc. · Accessories, Cleaning, For Endoscope24 reports
- SSD-102Medivators Inc. · Accessories, Cleaning, For Endoscope3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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