CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report
Acceava Respiratory Strep A, CLIA Waived recalled
Cypress Medical Products is recalling Acceava Respiratory Strep A, CLIA Waived, distributed nationwide in the US. The recall was initiated on 20 Aug 2024 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-3185-2024
- FDA event ID
- 95235
- Recalling firm
- Cypress Medical Products, Richmond, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2024
- FDA classified
- 19 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 20 Aug 2024 | Recall initiated by company | |
| 19 Sep 2024 | Classified by FDA | +30 days |
| 25 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Product as listed by the FDA
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Which lots are affected?
GTIN: 10815845020031; All Lots
Where was it sold?
US Nationwide distribution.
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
1 other product · FDA event 95235This product is part of a recall event; the main page for the event is BinaxNOW Respiratory Strep A Test Kit, CLIA Waived recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived recalled | Cypress Medical Products | Other | Nationwide |
More recalls from Cypress Medical Products
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | General Purpose Syringe McKesson Luer Lock Tip Without Safety recalled | Cypress Medical Products | Other | Nationwide |
| Device | CLASS II | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived recalled | Cypress Medical Products | Other | Nationwide |
| Device | CLASS II | McKesson Syringe 60CC, Luer Lock Tip, Sterile recalled | Cypress Medical Products | Other | Nationwide |
| Device | CLASS II | McKesson Lap Sponge, X-Ray Detectable 12"x 12" recalled | Cypress Medical Products | Sterility | VA |
| Device | CLASS III | McKesson Consult Diagnostic Immunochemical Fecal Occult recalled | Cypress Medical Products | Packaging Defects | 27 states |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |