OPTI Medical Systems, Inc: FDA recalls
FDA enforcement events from 2012 to 2021; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.
FDA enforcement reports name OPTI Medical Systems, Inc as the recalling firm in 3 events. The events have 3 product records. The recalls started from 2012 to 2021. All the events are device recalls. By FDA enforcement events, OPTI Medical Systems, Inc is number 1,113 of 1,628 firms that have a page. Events that OPTI Medical Systems, Inc started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
3 events, newest first.
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 25 Jun 2021 | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 | Device | Class II | 1 | Ongoing |
| 9 Aug 2013 | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma. | Device | Class II | 1 | Terminated |
| 3 Jul 2012 | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the… | Device | Class II | 1 | Terminated |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
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Type and class
| Type | Events |
|---|---|
| Device | 3 |
| Class | Events |
|---|---|
| Class II | 3 |
- Share of the events of the firm in Class I
- 0%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 1
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. OPTI Medical Systems, Inc: FDA recalls. https://recallregister.com/firm/opti-medical-systems-inc/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 3 Nov 2026
- State of the firm address
- GA
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of OPTI Medical Systems, Inc have?
- Class II: 3 events. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of OPTI Medical Systems, Inc?
- FDA event 88344, which the firm started on 25 Jun 2021. The first product in the record is:
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
- How many FDA recalls of OPTI Medical Systems, Inc have the status Ongoing?
- 1 event has the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.