Reported Jun 25, 2025 · Ongoing

Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT…

Balt USA, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BALT USA, LLC · 29 Parker Ste 100 · Irvine, CA · 92618-1667

Is this the product you have?

40 of 40 products

Products covered by this recall
Model / numberProduct as published
00810068567311Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT
00810068567663PRES1045CPKPLT
00810068567694PRES1245CPKPLT
00810068567724PRES1445CPKPLT
00810068567304PRES0103CXPPLT
00810068567397PRES2512CXPPLT
00810068567380PRES0258CXPPLT
00810068567373PRES0212CXPPLT
00810068567342PRES0204CXPPLT
00810068567359PRES0206CXPPLT
00810068567366PRES0208CXPPLT
00810068567441PRES3520CXPPLT
00810068567458PRES3530CXPPLT
00810068567403PRES0310CXPPLT
00810068567410PRES0320CXPPLT
00810068567489PRES0420CPKPLT
00810068567519PRES0517CPKPLT
00810068568028PRES0540CPKPLT
00810068567557PRES0620CPKPLT
00810068567564PRES0635CPKPLT
Lot codes and dates

110 of 110 products

Products covered by this recall
Model / numberBarcodesProduct as published
PRES0153CXPPLT00810068567311F230800442 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk
PRES0153CXPPLT00810068567311F230800505 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk
PRES0153CXPPLT00810068567311F230800708 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk
PRES0153CXPPLT00810068567311F230800794 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack
PRES1045CPKPLT00810068567663F230800513 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack
PRES1045CPKPLT00810068567663F230800544 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack
PRES1245CPKPLT00810068567694F230800512 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack
PRES1245CPKPLT00810068567694F230800538 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack
PRES1245CPKPLT00810068567694F230800790 PRES1445CPKPLT Prestige 14mm x 45cm (Ver. T) Prestige Plus Complex Pack
PRES1445CPKPLT00810068567724F230800793 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0103CXPPLT00810068567304F230800574 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0103CXPPLT00810068567304F230800575 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0103CXPPLT00810068567304F230800576 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0103CXPPLT00810068567304F230800947 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES2512CXPPLT00810068567397F230800549 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES2512CXPPLT00810068567397F230800759 PRES0258CXPPLT Prestige 2.5mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0258CXPPLT00810068567380F230800833 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0212CXPPLT00810068567373F230800515 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0212CXPPLT00810068567373F230800527 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk
PRES0212CXPPLT00810068567373F230800578 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk
Amount recalled
1754 devices

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.