Blue Belt Technologies, Inc
Blue Belt Technologies, Inc has 3 FDA enforcement events on this register (3 product records) between 2023 and 2024: 3 device; the busiest year was 2023 with 2.
0% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in PA.
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 |
|---|---|---|---|---|---|
| 7 May 2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real… | Device | Class II | 1 | Ongoing |
| 13 Nov 2023 | CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S | Device | Class II | 1 | Ongoing |
| 7 Sep 2023 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 | Device | Class II | 1 | Ongoing |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Blue Belt Technologies, Inc had?
3 enforcement events (3 product records) on this register, 2023–2024: 3 device.
Are any Blue Belt Technologies, Inc recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are Blue Belt Technologies, 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.