Vaporizer Plate Vaporizer Plate Consumable accessory used… recallZ-0197-06 · Advanced Sterilization Products · initiated Sep 16, 2005
Terminated All recalls posted in November 2005
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 Advanced Sterilization Products 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 STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load.
FDA root cause category: Other
What the company is doing
The recall strategy consists of supplying each customer of the STERRAD 100 and the STERRAD 1OOS with: a notification letter of the field action (mailed 09/22/05 ), a pack containing two vaporizer plates of the newly released design, and a set of instructions for self-installation.
Recall details
- Recall number
- Z-0197-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 16, 2005
- Posted by the FDA
- Nov 24, 2005
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 5365
- Product code
- MLR
- FDA submissions
- K991999
- Distribution
- Nationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.
Product description
Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
Code information (models, lots, serial numbers)
20220 STERRAO 100 Accessory Kit 1.8 20221 STERRAO 100 Accessory Kit 2.0 20222 STERRAO 100 Accessory Kit 2.0 Same as 20221 except single ply paper 20223 STERRAO 1 DOS Accessory Kit A (For use with Block 1.8 STERRAO 100S) 20224 STERRAO 1 DOS Accessory Kit B (For use with Block 2.0 STERRAO 1 DOS) 20225 STERRAO 100S Accessory Kit C (For use with Block 2.0 STERRAO System & Block 1.8 STERRAO with Printer UpQrade kit install 03-53045- 1- 001 Vaporizer Plate, Shelf Pac 03-05660- 0- 001
Other devices under the same FDA submission
2 devices cleared under K991999 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sterrad 10101Advanced Sterilization Products Services Inc. · Sterilizer, ethylene-oxide gas258 reports
- STERRAD™ 10113Advanced Sterilization Products Services Inc. · Sterilizer, chemical2 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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