CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
Overlap Vest, Single recalled by Burlington Medical
Burlington Medical is recalling Overlap Vest, Single, distributed nationwide in the US. The recall was initiated on 7 Jun 2019 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-2115-2019
- FDA event ID
- 83144
- Recalling firm
- Burlington Medical, Newport News, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2019
- FDA classified
- 30 Jul 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Jun 2019 | Recall initiated by company | |
| 30 Jul 2019 | Classified by FDA | +53 days |
| 7 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Product as listed by the FDA
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Where it was distributed
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Stores named: Walmart
Questions about this recall
Is Overlap Vest, Single recalled?
Yes. Burlington Medical recalled Overlap Vest, Single on 7 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2115-2019.
Why was it recalled?
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Which lots are affected?
Serial Numbers: 385688 387953 385694 385696 387781 384424 382874
Where was it sold?
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
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.
More recalls from Burlington Medical
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BAT (Breast, Axilla and Thyroid) Coverage recalled by Burlington Medical | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Burlington Medical, Kilt recalled | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Burlington Medical, Caps recalled | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Thyroid Shield recalled by Burlington Medical | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Burlington Medical, Blockers recalled | Burlington Medical | Potency & Assay | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |