CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

Protective Sleeves recalled by Burlington Medical

Burlington Medical is recalling Burlington Medical, Protective Sleeves, distributed nationwide in the US. The recall was initiated on 11 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).

Quantity recalled1,129 units

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-1759-2026
FDA event ID: 98415
Recalling firm: Burlington Medical, Newport News, VA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Feb 2026
FDA classified: 2 Apr 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

11 Feb 2026	Recall initiated by company
2 Apr 2026	Classified by FDA	+50 days
8 Apr 2026	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

Potential for attenuation degradation over time, decreasing the lifespan.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Burlington Medical, Protective Sleeves.

Where it was distributed

Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.

Nationwide

Questions about this recall

Is Protective Sleeves recalled?

Yes. Burlington Medical recalled Protective Sleeves on 11 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1759-2026.

Why was it recalled?

Potential for attenuation degradation over time, decreasing the lifespan.

Which lots are affected?

All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8SL; UDI-DI (Product Code): 00840331271904 (SL8-R8SL). 2. Model Number: R8SL3; UDI-DI (Product Code): 00840331271911 (SL38-R8SL3-LG), 00840331271928 (SL38-R8SL3-MD), 00840331271935 (SL38-R8SL3-SM), 00840186699816 (SL38-R8SL3-XL), 00840331271942 (SL38-R8SL3-XS). 3. Model Number: S8SL; UDI-DI (Product Code): 00840331271959 (SL8-S8SL). 4. Model Number: S8SL3; UDI-DI (Product Code): 00840331271966 (SL38-S8SL3-LG), 00840331271973 (SL38-S8SL3-MD), 00840331271980 (SL38-S8SL3-SM), 00840186699823 (SL38-S8SL3-XL), 00840331271997 (SL38-S8SL3-XS). 5. Model Number: U8SL; UDI-DI (Product Code): 00840331272000 (SL8-U8SL). 6. Model Number: U8SL3; UDI-DI (Product Code): 00840331272017 (SL38-U8SL3-LG), 00840331272024 (SL38-U8SL3-MD), 00840331272031 (SL38-U8SL3-SM), 00840186699830 (SL38-U8SL3-XL), 00840331272048 (SL38-U8SL3-XS).

Where was it sold?

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.

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