CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
i-STAT EG7+ cartridge recalled by Abbott Point Of Care
Abbott Point Of Care is recalling i-STAT EG7+ cartridge, distributed nationwide in the US. The recall was initiated on 1 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1999-2026
- FDA event ID
- 98635
- Recalling firm
- Abbott Point Of Care, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2026
- FDA classified
- 29 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Apr 2026 | Recall initiated by company | |
| 29 Apr 2026 | Classified by FDA | +28 days |
| 6 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Product as listed by the FDA
i-STAT EG7+ cartridge; List Number: 03P76-25;
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.
Questions about this recall
Why was it recalled?
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Which lots are affected?
List Number: 03P76-25; UDI-DI: 00054749000043; Lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98635This product is part of a recall event; the main page for the event is i-STAT G3+ cartridge recalled by Abbott Point Of Care.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | i-STAT G3+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide | |
| CLASS II | i-STAT EG6+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
More recalls from Abbott Point Of Care
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | i-STAT EG6+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT G3+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT CG8+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT CG4+ cartridge (white) recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
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| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |