CLASS II Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
Hays Ultrasound kit recalled by Exact Medical Manufacturing
Exact Medical Manufacturing is recalling Hays Ultrasound kit, distributed in Florida, Georgia, Montana, New York, Ohio, Puerto Rico. The recall was initiated on 29 Apr 2021 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-1918-2021
- FDA event ID
- 87958
- Recalling firm
- Exact Medical Manufacturing, Lancaster, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2021
- FDA classified
- 21 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 29 Apr 2021 | Recall initiated by company | |
| 21 Jun 2021 | Classified by FDA | +53 days |
| 30 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
No 510k for the product to be used in a natural or surgical opening to the body
Product as listed by the FDA
Hays Ultrasound kit Item ID: H1000SE
Where it was distributed
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Questions about this recall
Why was it recalled?
No 510k for the product to be used in a natural or surgical opening to the body
Which lots are affected?
Lot Numbers: 2005E090 2006E495
Where was it sold?
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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 21 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
17 other products · FDA event 87958More recalls from Exact Medical Manufacturing
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover recalled | Exact Medical Manufacturing | Other | 6 states |
| Device | CLASS II | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands recalled | Exact Medical Manufacturing | Other | 6 states |
| Device | CLASS II | 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq recalled | Exact Medical Manufacturing | Other | 6 states |
| Device | CLASS II | Probe Cover, 6"x96" poly, tapered end recalled | Exact Medical Manufacturing | Other | 6 states |
| Device | CLASS II | Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole recalled | Exact Medical Manufacturing | Other | 6 states |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |