FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc., dba Datascope Patient Monitoring: SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe.
- Recall number
- Z-1397-2010
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- Product
- SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe.
- Status
- Terminated
- Initiated
- 2009-12-31
- Posted
- 2010-04-15
- Terminated
- 2011-12-09
- Reason
- SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.
- Root cause
- Process control
- Action
- Mindray DS USA, Inc. issued an "Urgent Product Recall" notification dated December 31, 2009 by certified mail. Consignees were informed of the affected product and requested to discard all remaining stock. Replacement product will be provided by the firm at no cost. For further information, contact Mindray DS USA, Inc. at 1-201-995-8000.
- Quantity
- Total: 33,976 boxes of 20 (boxes of 20 packaged into boxes of 200) in US, 801 boxes OUS
- Distribution
- Worldwide Distribution -- United States, Canada and Australia. Nationwide distribution to hospitals, medical facilities and distributors as well as to Canada and Australia.
- Lot, serial or model codes
- All lots of the following product numbers: 1. M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200) 2. A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits: 0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit.
- 510(k) numbers
- ["K072235"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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