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Burlington Medical, LLC
Burlington Medical, LLC: 37 FDA recall reports
Every medical device recall the FDA has published for Burlington Medical, LLC. The fault, and how the agency graded it.
37Reports
0Class I
13Ongoing
2026-04-08Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Burlington Medical, Wrap Aprons.
Z-1757-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Wrap Aprons.
- Where it went
- 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.
- How much
- 5,198 units
Burlington Medical, Leg Wraps.
Z-1761-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Leg Wraps.
- Where it went
- 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.
- How much
- 103 units
Burlington Medical, Half Aprons.
Z-1762-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Half Aprons.
- Where it went
- 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.
- How much
- 402 units
Burlington Medical, Vest
Z-1754-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Vest
- Where it went
- 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.
- How much
- 15,438 units
Burlington Medical, Demi Half Aprons.
Z-1763-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Demi Half Aprons.
- Where it went
- 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.
- How much
- 29 units
Burlington Medical, Kilt Blockers.
Z-1765-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Kilt Blockers.
- Where it went
- 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.
- How much
- 94 units
Burlington Medical, Protective Sleeves.
Z-1759-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Protective Sleeves.
- Where it went
- 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.
- How much
- 1,129 units
Burlington Medical, Frontal Aprons
Z-1756-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Frontal Aprons
- Where it went
- 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.
- How much
- 14323
Burlington Medical, Blockers.
Z-1764-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Blockers.
- Where it went
- 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.
- How much
- 51 units
Burlington Medical, Thyroid Shield.
Z-1753-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Thyroid Shield.
- Where it went
- 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.
- How much
- 41,962 units
Burlington Medical, Caps.
Z-1760-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Caps.
- Where it went
- 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.
- How much
- 961 units
Burlington Medical, Kilt
Z-1755-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, Kilt
- Where it went
- 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.
- How much
- 15,216 units
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Z-1758-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Potential for attenuation degradation over time, decreasing the lifespan.
- Product
- Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
- Where it went
- 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.
- How much
- 1,489 units
Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product
Z-2124-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 1
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healt
Z-2128-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 3
Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17
Z-2108-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, UEF17XXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 104
Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Us
Z-2109-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 6
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFV
Z-2115-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 7
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REV
Z-2113-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 22
2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD,
Z-2114-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 129
Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEURO
Z-2125-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 48
2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECS
Z-2112-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 310
Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKI
Z-2118-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 37
Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usag
Z-2123-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 39
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-S
Z-2122-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 807
Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T P
Z-2130-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 23
Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLT
Z-2119-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 210
2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, RE
Z-2116-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 332
Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products are desig
Z-2129-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 9
Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*
Z-2110-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was 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.
- Product
- Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
- Where it went
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- How much
- 23
Showing the 30 most recent of 37. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls