The Recall Desk
HighFDA (Devices)·Z-2429-2020·Announced 2020-07-01

Suntech Oscar 2 Blood Pressure Monitor Recall for Display Error

Suntech Medical is recalling Oscar 2 blood pressure monitors because the display may show an incorrect decimal point for three-digit readings in mmHg.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the device is a medical instrument where incorrect readings pose a risk of harm, although no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Suntech Medical, Inc. is recalling 1,037 units of the Oscar 2, Model 250 System blood pressure monitor. The recall was initiated because the device display can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set to mmHg.

The affected units were distributed nationwide to California, Connecticut, Florida, Illinois, Louisiana, Maryland, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, and Utah. They were also distributed worldwide to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, United Kingdom, and Vietnam.

Consumers should check their device serial number against the list provided in the official recall notice to determine if their unit is affected. If the serial number matches, users should stop using the device and contact Suntech Medical for instructions on repair or replacement.

The recalled product

Product
Oscar 2, Model 250 System
Manufacturer
Suntech Medical, Inc.
Category
Medical Device — Blood Pressure Monitor
Hazard
Affected units
1,037

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog Numbers (Serial Numbers): 99-0133-00 (SN:00101086
  • SN:00101159
  • SN:00101248
  • SN:00102173
  • SN:00107798
  • SN:00112277
  • SN:00113151
  • SN:00113262
  • SN:00113268
  • SN:00113279
  • SN:00113717
  • SN:00113838
  • SN:00114084
  • SN:00114513
  • SN:00115988
  • SN:00116238
  • SN:00116258
  • SN:00116331
  • SN:00116380
  • SN:00116384

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Related recalls

Same manufacturer · Suntech Medical, Inc.

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Same hazard · display error

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