Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 6, 2026
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillar…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics Inc recalled epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Nu… - a moderate-severity action.
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Nu… was recalled by Siemens Healthcare Diagnostics Inc in May 6, 2026. Reason: Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results…. Check the official notice for the remedy. Verify recall #Z-2005-2026 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics Inc issued this moderate-severity FDA Devices recall-Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results….
- Moderate
- severity level
- Class II
- classification
- May 6, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2005-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2005-2026) was formally reported on May 6, 2026, with the manufacturer initiating the action on April 2, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Healthcare Diagnostics Inc is listed as the recalling firm, operating out of Norwood, MA. Federal records list the affected scope as 71725 (38025 US, 33700 OUS).
The documented reason for this recall is: Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
71725 (38025 US, 33700 OUS)
Related Recalls
6
3 from same agency
Product description
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Reason for recall
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2005-2026 |
| Date reported | May 6, 2026 |
| Date initiated | April 2, 2026 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Firm location | Norwood, MA |
| Affected scope | 71725 (38025 US, 33700 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2005-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 71725 (38025 US, 33700 OUS).
Why was this product recalled? ▼
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2026. Severity: Moderate. Recall number: Z-2005-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2005-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 6, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.