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FDA Medical Device Recalls (openFDA)

Steris Corp: Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).

Recall number
Z-1193-2007
Recalling firm
Steris Corp
Product
Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).
Status
Terminated
Initiated
2007-03-22
Posted
2007-08-23
Terminated
2010-09-28
Reason
The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.
Root cause
Employee error
Action
By telephone 3/22/2007, customers were instructed to cease using the product and a service technician would be dispatched immediately to repair the unit.
Quantity
78
Distribution
Worldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.
Lot, serial or model codes
Prevac Steam Sterilizer, Model #'s V-136H, V-148H, V-160H, SV-148H, V-1264 & V-1263& SFPP Steam Sterilizer, Model #'s P-148H & P-160H.   Code # B093934202, B093924204, B09324223, B093924225, B093924227, B093924229, B093924233, B093924244, B093924246, B093924248, B093924250, B093924286, B093924288, B093924296, B093924307, B093924309, B093924310, B093924434, B093924476, B093927301, B093927302, B093927322, B300903936
510(k) numbers
["K010865"]
PMA numbers
not on file
Product code
FLE
Firm FEI
1527821
Firm city
Mentor
Firm state
OH
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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