OPTI Medical Systems, Inc

FDA recalling firm · 3 enforcement events · 3 product records · 2012–2021 · GA

OPTI Medical Systems, Inc has 3 FDA enforcement events on this register (3 product records) between 2012 and 2021: 3 device; the busiest year was 2012 with 1.

0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in GA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

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

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for OPTI Medical Systems, Inc by year initiated.

Questions and answers

How many FDA recalls has OPTI Medical Systems, Inc had?

3 enforcement events (3 product records) on this register, 2012–2021: 3 device.

Are any OPTI Medical Systems, Inc recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are OPTI Medical Systems, Inc recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.