CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
Dressing Rect L recalled by Breg
Breg is recalling Dressing Rect L, distributed nationwide in the US. The recall was initiated on 30 Mar 2017 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-1903-2017
- FDA event ID
- 76994
- Recalling firm
- Breg, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2017
- FDA classified
- 1 May 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2017 | Recall initiated by company | |
| 1 May 2017 | Classified by FDA | +32 days |
| 10 May 2017 | 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
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Dressing Rect L recalled?
Yes. Breg recalled Dressing Rect L on 30 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1903-2017.
Why was it recalled?
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Which lots are affected?
D163474, D163544
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 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 Breg
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Breg REF 100519-000 Walker Folding Walker With Wheels Utilized as recalled | Breg | Other | 41 states |
| Device | CLASS II | If Hip, Sterile Polar Dressing recalled by Breg | Breg | Sterility | Nationwide |
| Device | CLASS II | Dressing Shldr recalled by Breg | Breg | Sterility | Nationwide |
| Device | CLASS II | Dressing Knee/Shldr recalled by Breg | Breg | Sterility | Nationwide |
| Device | CLASS II | Dressing Back recalled by Breg | Breg | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |