FDA Device recall Z-0043-2014
STERRAD 200 Sterilizer (Single Door), Part Number: 10201
- FDA Device
- Class II
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class II recall of STERRAD 200 Sterilizer (Single Door), Part Number: 10201 by Advanced Sterilization Products, citing advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0043-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-18 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Reason
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Identifiers
| code_info | Lot A: 0009*ENG 0003*FG 0048*FG 0050*MRB 0237*YAMATO 0239*YAMATO 0097*FSRIP 0097*FG 315*TTL 316…Lot A: 0009*ENG 0003*FG 0048*FG 0050*MRB 0237*YAMATO 0239*YAMATO 0097*FSRIP 0097*FG 315*TTL 316*TTL 317*TTL 318*TTL 314*FG 325*TTL 326*TTL 334*FG 335*FG 329*TTL 345*TTL 357*FG 359*FG 358*FG 344*TTL 351*FG 347*TTL 352*TTL 348*TTL 348*FG 360*TTL 361*TTL 364*FG 362*TTL 383*YAMATO 365*TTL 368*TTL 371*FG 369*TTL 370*TTL 374*TTL 378*TTL 379*TTL 397*TTL 376*TTL 398*TTL 400*TTL 401*TTL 402*TTL 386*TTL 403*TTL 404*TTL 406*TTL 405*TTL 399*TTL 419*TTL 388*TTL 420*TTL 421*TTL 0239*CD33 422*TTL 423*TTL 429*YAMATO 424*TTL 439*YAMATO 425*TTL 427*TTL 346*TTL 423*TTL 372*TTL 430*TTL 428*TTL 395*TTL 431*TTL 433*TTL 447*YAMATO 432*TTL 434*TTL 435*TTL 437*TTL 436*TTL 453*YAMATO 454*YAMATO 452*YAMATO 440*TTL 412*TTL 455*YAMATO 456*YAMATO 468*FG 460*FG 458*FG 459*FG 462*FG 463*FG 464*FG 473*FG 470*FG 465*FG 488*YAMATO 476*FG 481*FG 487* |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0043-2014%22
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