Recall archive / FDA device enforcement

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming s... — FDA record Z-0753-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 21, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
Reason: Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (
Classification: Class II
Recalling firm: Abbott Medical
Quantity: 7295 programmers
Agency-reported status: Ongoing
Source record identifier: Z-0753-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Programmer Model Number: 3650 UDI-DI code: 05414734509725 Software Version Number / Serial Numbers: 28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2 12050154 28.0.1 REV 2 12051352 28.0.1 REV 2 12051615 28.0.1 REV 2 12056133 28.0.1 REV 2 12713 28.0.1 REV 2 14655 28.0.1 REV 2 23324 28.0.1 REV 2 24050 28.0.1 REV 2 12042174 28.0.1 REV 2 12042239 28.0.1 REV 2 12048730 28.0.1 REV 2 11959 28.0.1 REV 2 16116 28.0.1 REV 2 16571 28.0.1 REV 2 27499 28.0.1 REV 2 12056125 28.0.1 REV 2 15378 28.0.1 REV 2 18041 28.0.1 REV 2 27164 28.0.1 REV 2 12045425 28.0.1 REV 2 12045483 28.0.1 REV 2 12870 28.0.1 REV 2 14910 28.0.1 REV 2 18143 28.0.1 REV 2 21904 28.0.1 REV 2 23317 28.0.1 REV 2 12043799 28.0.1 REV 2 12044806 28.0.1 REV 2 12055973 28.0.1 REV 2 24842 28.0.1 REV 2 12040739 28.0.1 REV 2 12042686 28.0.1 REV 2 12044212 28.0.1 REV 2 12045527 28.0.1 REV 2 12052141 28.0.1 REV 2 12055384 28.0.1 REV 2 12052537 28.0.1 REV 2 19660 28.0.1 REV 2 21099 28.0.1 REV 2 24610 28.0.1 REV 2 30022 28.0.1 REV 2 12044540 28.0.1 REV 2 12047076 28.0.1 REV 2 12053304 28.0.1 REV 2 12706 28.0.1 REV 2 20207 28.0.1 REV 2 20933 28.0.1 REV 2 22212 28.0.1 REV 2 25022 28.0.1 REV 2 27371 28.0.1 REV 2 12044759 28.0.1 REV 2 12045223 28.0.1 REV 2 12052322 28.0.1 REV 2 12056132 28.0.1 REV 2 12060627 28.0.1 REV 2 12061640 28.0.1 REV 2 11628 28.0.1 REV 2 11891 28.0.1 REV 2 20861 28.0.1 REV 2 22163 28.0.1 REV 2 25164 28.0.1 REV 2 25942 28.0.1 REV 2 26189 28.0.1 REV 2 12040940 28.0.1 REV 2 12041991 28.0.1 REV 2 12045260 28.0.1 REV 2 12046359 28.0.1 REV 2 12051613 28.0.1 REV 2 12052588 28.0.1 REV 2 12055272 28.0.1 REV 2 12061523 28.0.1 REV 2 12073 28.0.1 REV 2 12386 28.0.1 REV 2 21011 28.0.1 REV 2 22744 28.0.1 REV 2 23629 28.0.1 REV 2 23881 28.0.1 REV 2 12048206 28.0.1 REV 2 12048470 28.0.1 REV 2 12138 28.0.1 REV 2 12330 28.0.1 REV 2 16714 28.0.1 REV 2 20209 28.0.1 REV 2 21538 28.0.1 REV 2 23327 28.0.1 REV 2 24046 28.0.1 REV 2 25837 28.0.1 REV 2 12050165 28.0.1 REV 2 12051284 28.0.1 REV 2 12055859 28.0.1 REV 2 12055880 28.0.1 REV 2 16005 28.0.1 REV 2 12044210 28.0.1 REV 2 12044518 28.0.1 REV 2 12045375 28.0.1 REV 2 15043 28.0.1 REV 2 16127 28.0.1 REV 2 20025 28.0.1 REV 2 20956 28.0.1 REV 2 23113 28.0.1 REV 2 12042772 28.0.1 REV 2 12043605 28.0.1 REV 2 12048109 28.0.1 REV 2 11809 28.0.1 REV 2 16010 28.0.1 REV 2 25882 28.0.1 REV 2 26257 28.0.1 REV 2 27159 28.0.1 REV 2 12042806 28.0.1 REV 2 12061445 28.0.1 REV 2 11991 28.0.1 REV 2 12554 28.0.1 REV 2 16954 28.0.1 REV 2 17842 28.0.1 REV 2 20400 28.0.1 REV 2 26405 28.0.1 REV 2 12041928 28.0.1 REV 2 12044597 28.0.1 REV 2 12048812 28.0.1 REV 2 12060584 28.0.1 REV 2 24146 28.0.1 REV 2 12046557 28.0.1 REV 2 12048311 28.0.1 REV 2 12060407 28.0.1 REV 2 15175 28.0.1 REV 2 19180 28.0.1 REV 2 12045434 28.0.1 REV 2 12052162 28.0.1 REV 2 12055217 28.0.1 REV 2 11577 28.0.1 REV 2 16703 28.0.1 REV 2 16840 28.0.1 REV 2 19150 28.0.1 REV 2 26198 28.0.1 REV 2 26493 28.0.1 REV 2 28038 28.0.1 REV 2 12044032 28.0.1 REV 2 12050131 28.0.1 REV 2 12052590 28.0.1 REV 2 12055295 28.0.1 REV 2 12060629 28.0.1 REV 2 15257 28.0.1 REV 2 17658 28.0.1 REV 2 30735 28.0.1 REV 2 12045895 28.0.1 REV 2 12046696 28.0.1 REV 2 12047207 28.0.1 REV 2 12050175 28.0.1 REV 2 12051144 28.0.1 REV 2 22419 28.0.1 REV 2 22943 28.0.1 REV 2 30704 28.0.1 REV 2 12040805 28.0.1 REV 2 12044618 28.0.1 REV 2 12046363 28.0.1 REV 2 25194 28.0.1 REV 2 12045242 28.0.1 REV 2 12045276 28.0.1 REV 2 12051266 28.0.1 REV 2 11373 28.0.1 REV 2 18152 28.0.1 REV 2 12040924 28.0.1 REV 2 12041295 28.0.1 REV 2 22299 28.0.1 REV 2 24386 28.0.1 REV 2 24492 28.0.1 REV 2 25569 28.0.1 REV 2 12048312 28.0.1 REV 2 12048422 28.0.1 REV 2 12051199 28.0.1 REV 2 12052525 28.0.1 REV 2 11635 28.0.1 REV 2 17295 28.0.1 REV 2 20479 28.0.1 REV 2 23627 28.0.1 REV 2 12044434 28.0.1 REV 2 12045558 28.0.1 REV 2 12055864 28.0.1 REV 2 16105 28.0.1 REV 2 24762 28.0.1 REV 2 25147 28.0.1 REV 2 26011 28.0.1 REV 2 12041951 28.0.1 REV 2 12051079 28.0.1 REV 2 12051168 28.0.1 REV 2 12060736 28.0.1 REV 2 15926 28.0.1 REV 2 21177 28.0.1 REV 2 30016 28.0.1 REV 2 12060805 28.0.1 REV 2 16966 28.0.1 REV 2 20250 28.0.1 REV 2 20886 28.0.1 REV 2 21876 28.0.1 REV 2 24760 28.0.1 REV 2 26628 28.0.1 REV 2 27295 28.0.1 REV 2 27700 28.0.1 REV 2 27933 28.0.1 REV 2 12047177 28.0.1 REV 2 12048506 28.0.1 REV 2 12049432 28.0.1 REV 2 12060785 28.0.1 REV 2 24999 28.0.1 REV 2 12048294 28.0.1 REV 2 16828 28.0.1 REV 2 16907 28.0.1 REV 2 22241 28.0.1 REV 2 24884 28.0.1 REV 2 25075 28.0.1 REV 2 23091 28.0.1 REV 2 24696 28.0.1 REV 2 25999 28.0.1 REV 2 30823 28.0.1 REV 2 12045679 28.0.1 REV 2 12052118 28.0.1 REV 2 12052305 28.0.1 REV 2 18554 28.0.1 REV 2 20197 28.0.1 REV 2 21939 28.0.1 REV 2 23161 28.0.1 REV 2 25940 28.0.1 REV 2 12042222 28.0.1 REV 2 12046932 28.0.1 REV 2 12051416 28.0.1 REV 2 12055874 28.0.1 REV 2 19968 28.0.1 REV 2 21014 28.0.1 REV 2 25308 28.0.1 REV 2 25876 28.0.1 REV 2 12049933 28.0.1 REV 2 12061366 28.0.1 REV 2 21140 28.0.1 REV 2 24552 28.0.1 REV 2 12044482 28.0.1 REV 2 23466 28.0.1 REV 2 23422 28.0.1 REV 2 11688 28.0.1 REV 2 12052631 28.0.1 REV 2 25422 28.0.1 REV 2 12045682 28.0.1 REV 2 24946 28.0.1 REV 2 20876 28.0.1 REV 2 12049422 28.0.1 REV 2 25962 28.0.1 REV 2 12043694 28.0.1 REV 2 19241 28.0.1 REV 2 20042 28.0.1 REV 2 23762 28.0.1 REV 2 12048510 28.0.1 REV 2 12051108 28.0.1 REV 2 12061482 28.0.1 REV 2 12048450 28.0.1 REV 2 19699 28.0.1 REV 2 12052609 28.0.1 REV 2 14964 28.0.1 REV 2 21909 28.0.1 REV 3 15024 28.0.1 REV 3 15071 28.0.1 REV 3 15394 28.0.1 REV 3 17875 28.0.1 REV 3 12041047 28.0.1 REV 3 12042155 28.0.1 REV 3 14785 28.0.1 REV 3 14882 28.0.1 REV 3 15272 28.0.1 REV 3 15645 28.0.1 REV 3 19453 28.0.1 REV 3 21665 28.0.1 REV 3 23850 28.0.1 REV 3 25024 28.0.1 REV 3 12044251 28.0.1 REV 3 12052328 28.0.1 REV 3 11971 28.0.1 REV 3 16152 28.0.1 REV 3 20827 28.0.1 REV 3 27705 28.0.1 REV 3 12044657 28.0.1 REV 3 12049919 28.0.1 REV 3 12056081 28.0.1 REV 3 12061517 28.0.1 REV 3 12061540 28.0.1 REV 3 26178 28.0.1 REV 3 12041349 28.0.1 REV 3 14075 28.0.1 REV 3 15373 28.0.1 REV 3 19105 28.0.1 REV 3 19228 28.0.1 REV 3 21087 28.0.1 REV 3 24744 28.0.1 REV 3 12044142 28.0.1 REV 3 14007 28.0.1 REV 3 14782 28.0.1 REV 3 15928 28.0.1 REV 3 22448 28.0.1 REV 3 24561 28.0.1 REV 3 12041404 28.0.1 REV 3 12042086 28.0.1 REV 3 12043580 28.0.1 REV 3 12045905 28.0.1 REV 3 12048844 28.0.1 REV 3 12454 28.0.1 REV 3 14740 28.0.1 REV 3 15261 28.0.1 REV 3 20202 28.0.1 REV 3 26332 28.0.1 REV 3 27934 28.0.1 REV 3 12041063 28.0.1 REV 3 12048271 28.0.1 REV 3 12045488 28.0.1 REV 3 15423 28.0.1 REV 3 27848 28.0.1 REV 3 12045216 28.0.1 REV 3 12045453 28.0.1 REV 3 12048228 28.0.1 REV 3 11646 28.0.1 REV 3 23911 28.0.1 REV 3 26264 28.0.1 REV 3 12041335 28.0.1 REV 3 12051341 28.0.1 REV 3 12051667 28.0.1 REV 3 12060801 28.0.1 REV 3 11364 28.0.1 REV 3 12135 28.0.1 REV 3 14455 28.0.1 REV 3 12040818 28.0.1 REV 3 12040953 28.0.1 REV 3 12043618 28.0.1 REV 3 12046946 28.0.1 REV 3 19381 28.0.1 REV 3 16386 28.0.1 REV 3 16901 28.0.1 REV 3 12040798 28.0.1 REV 3 12051705 28.0.1 REV 3 11682 28.0.1 REV 3 20450 28.0.1 REV 3 24039 28.0.1 REV 3 12048318 28.0.1 REV 3 12054689 28.0.1 REV 3 12055869 28.0.1 REV 3 11371 28.0.1 REV 3 11708 28.0.1 REV 3 17280 28.0.1 REV 3 18084 28.0.1 REV 3 19840 28.0.1 REV 3 20380 28.0.1 REV 3 20459 28.0.1 REV 3 24679 28.0.1 REV 3 12042574 28.0.1 REV 3 12045237 28.0.1 REV 3 12050182 28.0.1 REV 3 12055311 28.0.1 REV 3 15305 28.0.1 REV 3 16595 28.0.1 REV 3 20483 28.0.1 REV 3 24217 28.0.1 REV 3 25972 28.0.1 REV 3 27666 28.0.1 REV 3 12056061 28.0.1 REV 3 11975 28.0.1 REV 3 16928 28.0.1 REV 3 20496 28.0.1 REV 3 20867 28.0.1 REV 3 25426 28.0.1 REV 3 26454 28.0.1 REV 3 12045804 28.0.1 REV 3 12051437 28.0.1 REV 3 12060033 28.0.1 REV 3 13668 28.0.1 REV 3 14794 28.0.1 REV 3 14983 28.0.1 REV 3 20065 28.0.1 REV 3 24357 28.0.1 REV 3 12045468 28.0.1 REV 3 17058 28.0.1 REV 3 19680 28.0.1 REV 3 27643 28.0.1 REV 3 12045570 28.0.1 REV 3 12050171 28.0.1 REV 3 12050187 28.0.1 REV 3 20188 28.0.1 REV 3 20442 28.0.1 REV 3 24027 28.0.1 REV 3 26432 28.0.1 REV 3 27592 28.0.1 REV 3 27743 28.0.1 REV 3 12049304 28.0.1 REV 3 15994 28.0.1 REV 3 28107 28.0.1 REV 3 12048078 28.0.1 REV 3 12060766 28.0.1 REV 3 18229 28.0.1 REV 3 22233 28.0.1 REV 3 23497 28.0.1 REV 3 25921 28.0.1 REV 3 30275 28.0.1 REV 3 12043589 28.0.1 REV 3 12044455 28.0.1 REV 3 18130 28.0.1 REV 3 23380 28.0.1 REV 3 23707 28.0.1 REV 3 12051098 28.0.1 REV 3 12055293 28.0.1 REV 3 20896 28.0.1 REV 3 23664 28.0.1 REV 3 27681 28.0.1 REV 3 12041300 28.0.1 REV 3 12044249 28.0.1 REV 3 12044699 28.0.1 REV 3 12051081 28.0.1 REV 3 12054754 28.0.1 REV 3 12055190 28.0.1 REV 3 12055550 28.0.1 REV 3 12398 28.0.1 REV 3 14676 28.0.1 REV 3 15073 28.0.1 REV 3 18068 28.0.1 REV 3 25127 28.0.1 REV 3 12042011 28.0.1 REV 3 12045140 28.0.1 REV 3 12045872 28.0.1 REV 3 12046244 28.0.1 REV 3 12052159 28.0.1 REV 3 12061378 28.0.1 REV 3 11790 28.0.1 REV 3 22079 28.0.1 REV 3 22797 28.0.1 REV 3 24471 28.0.1 REV 3 25938 28.0.1 REV 3 25968 28.0.1 REV 3 12041308 28.0.1 REV 3 12042662 28.0.1 REV 3 12045013 28.0.1 REV 3 12045721 28.0.1 REV 3 12048202 28.0.1 REV 3 12052134 28.0.1 REV 3 12054714 28.0.1 REV 3 12060802 28.0.1 REV 3 12469 28.0.1 REV 3 23798 28.0.1 REV 3 24089 28.0.1 REV 3 30709 28.0.1 REV 3 12044994 28.0.1 REV 3 12049444 28.0.1 REV 3 12051334 28.0.1 REV 3 11854 28.0.1 REV 3 17005 28.0.1 REV 3 19258 28.0.1 REV 3 21172 28.0.1 REV 3 23439 28.0.1 REV 3 24825 28.0.1 REV 3 27910 28.0.1 REV 3 12041331 28.0.1 REV 3 12043679 28.0.1 REV 3 12044986 28.0.1 REV 3 12048439 28.0.1 REV 3 12052263 28.0.1 REV 3 16702 28.0.1 REV 3 12044642 28.0.1 REV 3 12048466 28.0.1 REV 3 12060668 28.0.1 REV 3 15187 28.0.1 REV 3 23268 28.0.1 REV 3 24507 28.0.1 REV 3 12044610 28.0.1 REV 3 12052087 28.0.1 REV 3 12060663 28.0.1 REV 3 11863 28.0.1 REV 3 13959 28.0.1 REV 3 17266 28.0.1 REV 3 17741 28.0.1 REV 3 20356 28.0.1 REV 3 23582 28.0.1 REV 3 24413 28.0.1 REV 3 24972 28.0.1 REV 3 25773 28.0.1 REV 3 26112 28.0.1 REV 3 28029 28.0.1 REV 3 30012 28.0.1 REV 3 12050063 28.0.1 REV 3 15955 28.0.1 REV 3 25761 28.0.1 REV 3 26739 28.0.1 REV 3 30793 28.0.1 REV 3 12049901 28.0.1 REV 3 12051664 28.0.1 REV 3 12055810 28.0.1 REV 3 25265 28.0.1 REV 3 12055902 28.0.1 REV 3 22214 28.0.1 REV 3 22314 28.0.1 REV 3 12045485 28.0.1 REV 3 20005 28.0.1 REV 3 12046761 28.0.1 REV 3 12041886 28.0.1 REV 3 15004 28.0.1 REV 3 14988 28.0.1 REV 3 15513 28.0.1 REV 3 12381 28.0.1 REV 3 27344 28.0.1 REV 3 17640 28.0.1 REV 3 20222 28.0.1 REV 3 12429 28.0.1 REV 3 12044445 28.0.1 REV 3 19395 28.0.1 REV 3 26455 28.0.1 REV 3 19154 28.0.1 REV 3 12055956 28.0.1 REV 3 12041978 28.0.1 REV 3 12056082 28.0.1 REV 3 12042687 28.0.1 REV 3 27966 28.0.1 REV 3 14911 28.0.1 REV 3 17551 28.0.1 REV 3 12047002 28.0.1 REV 3 17462 28.0.1 REV 3 12055923 28.1.1 REV 1 18003 28.1.1 REV 1 19608 28.1.1 REV 1 23031 28.1.1 REV 1 25892 28.1.1 REV 1 12047062 28.1.1 REV 1 12053048 28.1.1 REV 1 12060701 28.1.1 REV 1 12310 28.1.1 REV 1 13817 28.1.1 REV 1 18019 28.1.1 REV 1 12043395 28.1.1 REV 1 12044648 28.1.1 REV 1 12045608 28.1.1 REV 1 12052959 28.1.1 REV 1 12053251 28.1.1 REV 1 12054669 28.1.1 REV 1 11819 28.1.1 REV 1 12152 28.1.1 REV 1 12206 28.1.1 REV 1 15031 28.1.1 REV 1 15476 28.1.1 REV 1 17871 28.1.1 REV 1 17912 28.1.1 REV 1 22167 28.1.1 REV 1 23984 28.1.1 REV 1 25969 28.1.1 REV 1 26712 28.1.1 REV 1 12040705 28.1.1 REV 1 12040809 28.1.1 REV 1 12042039 28.1.1 REV 1 12044422 28.1.1 REV 1 12048164 28.1.1 REV 1 12051084 28.1.1 REV 1 12051382 28.1.1 REV 1 12052034 28.1.1 REV 1 12052050 28.1.1 REV 1 12053203 28.1.1 REV 1 12005 28.1.1 REV 1 12564 28.1.1 REV 1 25820 28.1.1 REV 1 26419 28.1.1 REV 1 12042211 28.1.1 REV 1 12045204 28.1.1 REV 1 12045683 28.1.1 REV 1 12052633 28.1.1 REV 1 12256 28.1.1 REV 1 13627 28.1.1 REV 1 15312 28.1.1 REV 1 17877 28.1.1 REV 1 18020 28.1.1 REV 1 21117 28.1.1 REV 1 27039 28.1.1 REV 1 27673 28.1.1 REV 1 27913 28.1.1 REV 1 12041851 28.1.1 REV 1 12042084 28.1.1 REV 1 12046961 28.1.1 REV 1 12048566 28.1.1 REV 1 12051078 28.1.1 REV 1 12053189 28.1.1 REV 1 14952 28.1.1 REV 1 18057 28.1.1 REV 1 19093 28.1.1 REV...

Label field

Details supplied by the agency

Lot, code or applicability

Programmer Model Number: 3650 UDI-DI code: 05414734509725 Software Version Number / Serial Numbers: 28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2 12050154 28.0.1 REV 2 12051352 28.0.1 REV 2 12051615 28.0.1 REV 2 12056133 28.0.1 REV 2 12713 28.0.1 REV 2 14655 28.0.1 REV 2 23324 28.0.1 REV 2 24050 28.0.1 REV 2 12042174 28.0.1 REV 2 12042239 28.0.1 REV 2 12048730 28.0.1 REV 2 11959 28.0.1 REV 2 16116 28.0.1 REV 2 16571 28.0.1 REV 2 27499 28.0.1 REV 2 12056125 28.0.1 REV 2 15378 28.0.1 REV 2 18041 28.0.1 REV 2 27164 28.0.1 REV 2 12045425 28.0.1 REV 2 12045483 28.0.1 REV 2 12870 28.0.1 REV 2 14910 28.0.1 REV 2 18143 28.0.1 REV 2 21904 28.0.1 REV 2 23317 28.0.1 REV 2 12043799 28.0.1 REV 2 12044806 28.0.1 REV 2 12055973 28.0.1 REV 2 24842 28.0.1 REV 2 12040739 28.0.1 REV 2 12042686 28.0.1 REV 2 12044212 28.0.1 REV 2 12045527 28.0.1 REV 2 12052141 28.0.1 REV 2 12055384 28.0.1 REV 2 12052537 28.0.1 REV 2 19660 28.0.1 REV 2 21099 28.0.1 REV 2 24610 28.0.1 REV 2 30022 28.0.1 REV 2 12044540 28.0.1 REV 2 12047076 28.0.1 REV 2 12053304 28.0.1 REV 2 12706 28.0.1 REV 2 20207 28.0.1 REV 2 20933 28.0.1 REV 2 22212 28.0.1 REV 2 25022 28.0.1 REV 2 27371 28.0.1 REV 2 12044759 28.0.1 REV 2 12045223 28.0.1 REV 2 12052322 28.0.1 REV 2 12056132 28.0.1 REV 2 12060627 28.0.1 REV 2 12061640 28.0.1 REV 2 11628 28.0.1 REV 2 11891 28.0.1 REV 2 20861 28.0.1 REV 2 22163 28.0.1 REV 2 25164 28.0.1 REV 2 25942 28.0.1 REV 2 26189 28.0.1 REV 2 12040940 28.0.1 REV 2 12041991 28.0.1 REV 2 12045260 28.0.1 REV 2 12046359 28.0.1 REV 2 12051613 28.0.1 REV 2 12052588 28.0.1 REV 2 12055272 28.0.1 REV 2 12061523 28.0.1 REV 2 12073 28.0.1 REV 2 12386 28.0.1 REV 2 21011 28.0.1 REV 2 22744 28.0.1 REV 2 23629 28.0.1 REV 2 23881 28.0.1 REV 2 12048206 28.0.1 REV 2 12048470 28.0.1 REV 2 12138 28.0.1 REV 2 12330 28.0.1 REV 2 16714 28.0.1 REV 2 20209 28.0.1 REV 2 21538 28.0.1 REV 2 23327 28.0.1 REV 2 24046 28.0.1 REV 2 25837 28.0.1 REV 2 12050165 28.0.1 REV 2 12051284 28.0.1 REV 2 12055859 28.0.1 REV 2 12055880 28.0.1 REV 2 16005 28.0.1 REV 2 12044210 28.0.1 REV 2 12044518 28.0.1 REV 2 12045375 28.0.1 REV 2 15043 28.0.1 REV 2 16127 28.0.1 REV 2 20025 28.0.1 REV 2 20956 28.0.1 REV 2 23113 28.0.1 REV 2 12042772 28.0.1 REV 2 12043605 28.0.1 REV 2 12048109 28.0.1 REV 2 11809 28.0.1 REV 2 16010 28.0.1 REV 2 25882 28.0.1 REV 2 26257 28.0.1 REV 2 27159 28.0.1 REV 2 12042806 28.0.1 REV 2 12061445 28.0.1 REV 2 11991 28.0.1 REV 2 12554 28.0.1 REV 2 16954 28.0.1 REV 2 17842 28.0.1 REV 2 20400 28.0.1 REV 2 26405 28.0.1 REV 2 12041928 28.0.1 REV 2 12044597 28.0.1 REV 2 12048812 28.0.1 REV 2 12060584 28.0.1 REV 2 24146 28.0.1 REV 2 12046557 28.0.1 REV 2 12048311 28.0.1 REV 2 12060407 28.0.1 REV 2 15175 28.0.1 REV 2 19180 28.0.1 REV 2 12045434 28.0.1 REV 2 12052162 28.0.1 REV 2 12055217 28.0.1 REV 2 11577 28.0.1 REV 2 16703 28.0.1 REV 2 16840 28.0.1 REV 2 19150 28.0.1 REV 2 26198 28.0.1 REV 2 26493 28.0.1 REV 2 28038 28.0.1 REV 2 12044032 28.0.1 REV 2 12050131 28.0.1 REV 2 12052590 28.0.1 REV 2 12055295 28.0.1 REV 2 12060629 28.0.1 REV 2 15257 28.0.1 REV 2 17658 28.0.1 REV 2 30735 28.0.1 REV 2 12045895 28.0.1 REV 2 12046696 28.0.1 REV 2 12047207 28.0.1 REV 2 12050175 28.0.1 REV 2 12051144 28.0.1 REV 2 22419 28.0.1 REV 2 22943 28.0.1 REV 2 30704 28.0.1 REV 2 12040805 28.0.1 REV 2 12044618 28.0.1 REV 2 12046363 28.0.1 REV 2 25194 28.0.1 REV 2 12045242 28.0.1 REV 2 12045276 28.0.1 REV 2 12051266 28.0.1 REV 2 11373 28.0.1 REV 2 18152 28.0.1 REV 2 12040924 28.0.1 REV 2 12041295 28.0.1 REV 2 22299 28.0.1 REV 2 24386 28.0.1 REV 2 24492 28.0.1 REV 2 25569 28.0.1 REV 2 12048312 28.0.1 REV 2 12048422 28.0.1 REV 2 12051199 28.0.1 REV 2 12052525 28.0.1 REV 2 11635 28.0.1 REV 2 17295 28.0.1 REV 2 20479 28.0.1 REV 2 23627 28.0.1 REV 2 12044434 28.0.1 REV 2 12045558 28.0.1 REV 2 12055864 28.0.1 REV 2 16105 28.0.1 REV 2 24762 28.0.1 REV 2 25147 28.0.1 REV 2 26011 28.0.1 REV 2 12041951 28.0.1 REV 2 12051079 28.0.1 REV 2 12051168 28.0.1 REV 2 12060736 28.0.1 REV 2 15926 28.0.1 REV 2 21177 28.0.1 REV 2 30016 28.0.1 REV 2 12060805 28.0.1 REV 2 16966 28.0.1 REV 2 20250 28.0.1 REV 2 20886 28.0.1 REV 2 21876 28.0.1 REV 2 24760 28.0.1 REV 2 26628 28.0.1 REV 2 27295 28.0.1 REV 2 27700 28.0.1 REV 2 27933 28.0.1 REV 2 12047177 28.0.1 REV 2 12048506 28.0.1 REV 2 12049432 28.0.1 REV 2 12060785 28.0.1 REV 2 24999 28.0.1 REV 2 12048294 28.0.1 REV 2 16828 28.0.1 REV 2 16907 28.0.1 REV 2 22241 28.0.1 REV 2 24884 28.0.1 REV 2 25075 28.0.1 REV 2 23091 28.0.1 REV 2 24696 28.0.1 REV 2 25999 28.0.1 REV 2 30823 28.0.1 REV 2 12045679 28.0.1 REV 2 12052118 28.0.1 REV 2 12052305 28.0.1 REV 2 18554 28.0.1 REV 2 20197 28.0.1 REV 2 21939 28.0.1 REV 2 23161 28.0.1 REV 2 25940 28.0.1 REV 2 12042222 28.0.1 REV 2 12046932 28.0.1 REV 2 12051416 28.0.1 REV 2 12055874 28.0.1 REV 2 19968 28.0.1 REV 2 21014 28.0.1 REV 2 25308 28.0.1 REV 2 25876 28.0.1 REV 2 12049933 28.0.1 REV 2 12061366 28.0.1 REV 2 21140 28.0.1 REV 2 24552 28.0.1 REV 2 12044482 28.0.1 REV 2 23466 28.0.1 REV 2 23422 28.0.1 REV 2 11688 28.0.1 REV 2 12052631 28.0.1 REV 2 25422 28.0.1 REV 2 12045682 28.0.1 REV 2 24946 28.0.1 REV 2 20876 28.0.1 REV 2 12049422 28.0.1 REV 2 25962 28.0.1 REV 2 12043694 28.0.1 REV 2 19241 28.0.1 REV 2 20042 28.0.1 REV 2 23762 28.0.1 REV 2 12048510 28.0.1 REV 2 12051108 28.0.1 REV 2 12061482 28.0.1 REV 2 12048450 28.0.1 REV 2 19699 28.0.1 REV 2 12052609 28.0.1 REV 2 14964 28.0.1 REV 2 21909 28.0.1 REV 3 15024 28.0.1 REV 3 15071 28.0.1 REV 3 15394 28.0.1 REV 3 17875 28.0.1 REV 3 12041047 28.0.1 REV 3 12042155 28.0.1 REV 3 14785 28.0.1 REV 3 14882 28.0.1 REV 3 15272 28.0.1 REV 3 15645 28.0.1 REV 3 19453 28.0.1 REV 3 21665 28.0.1 REV 3 23850 28.0.1 REV 3 25024 28.0.1 REV 3 12044251 28.0.1 REV 3 12052328 28.0.1 REV 3 11971 28.0.1 REV 3 16152 28.0.1 REV 3 20827 28.0.1 REV 3 27705 28.0.1 REV 3 12044657 28.0.1 REV 3 12049919 28.0.1 REV 3 12056081 28.0.1 REV 3 12061517 28.0.1 REV 3 12061540 28.0.1 REV 3 26178 28.0.1 REV 3 12041349 28.0.1 REV 3 14075 28.0.1 REV 3 15373 28.0.1 REV 3 19105 28.0.1 REV 3 19228 28.0.1 REV 3 21087 28.0.1 REV 3 24744 28.0.1 REV 3 12044142 28.0.1 REV 3 14007 28.0.1 REV 3 14782 28.0.1 REV 3 15928 28.0.1 REV 3 22448 28.0.1 REV 3 24561 28.0.1 REV 3 12041404 28.0.1 REV 3 12042086 28.0.1 REV 3 12043580 28.0.1 REV 3 12045905 28.0.1 REV 3 12048844 28.0.1 REV 3 12454 28.0.1 REV 3 14740 28.0.1 REV 3 15261 28.0.1 REV 3 20202 28.0.1 REV 3 26332 28.0.1 REV 3 27934 28.0.1 REV 3 12041063 28.0.1 REV 3 12048271 28.0.1 REV 3 12045488 28.0.1 REV 3 15423 28.0.1 REV 3 27848 28.0.1 REV 3 12045216 28.0.1 REV 3 12045453 28.0.1 REV 3 12048228 28.0.1 REV 3 11646 28.0.1 REV 3 23911 28.0.1 REV 3 26264 28.0.1 REV 3 12041335 28.0.1 REV 3 12051341 28.0.1 REV 3 12051667 28.0.1 REV 3 12060801 28.0.1 REV 3 11364 28.0.1 REV 3 12135 28.0.1 REV 3 14455 28.0.1 REV 3 12040818 28.0.1 REV 3 12040953 28.0.1 REV 3 12043618 28.0.1 REV 3 12046946 28.0.1 REV 3 19381 28.0.1 REV 3 16386 28.0.1 REV 3 16901 28.0.1 REV 3 12040798 28.0.1 REV 3 12051705 28.0.1 REV 3 11682 28.0.1 REV 3 20450 28.0.1 REV 3 24039 28.0.1 REV 3 12048318 28.0.1 REV 3 12054689 28.0.1 REV 3 12055869 28.0.1 REV 3 11371 28.0.1 REV 3 11708 28.0.1 REV 3 17280 28.0.1 REV 3 18084 28.0.1 REV 3 19840 28.0.1 REV 3 20380 28.0.1 REV 3 20459 28.0.1 REV 3 24679 28.0.1 REV 3 12042574 28.0.1 REV 3 12045237 28.0.1 REV 3 12050182 28.0.1 REV 3 12055311 28.0.1 REV 3 15305 28.0.1 REV 3 16595 28.0.1 REV 3 20483 28.0.1 REV 3 24217 28.0.1 REV 3 25972 28.0.1 REV 3 27666 28.0.1 REV 3 12056061 28.0.1 REV 3 11975 28.0.1 REV 3 16928 28.0.1 REV 3 20496 28.0.1 REV 3 20867 28.0.1 REV 3 25426 28.0.1 REV 3 26454 28.0.1 REV 3 12045804 28.0.1 REV 3 12051437 28.0.1 REV 3 12060033 28.0.1 REV 3 13668 28.0.1 REV 3 14794 28.0.1 REV 3 14983 28.0.1 REV 3 20065 28.0.1 REV 3 24357 28.0.1 REV 3 12045468 28.0.1 REV 3 17058 28.0.1 REV 3 19680 28.0.1 REV 3 27643 28.0.1 REV 3 12045570 28.0.1 REV 3 12050171 28.0.1 REV 3 12050187 28.0.1 REV 3 20188 28.0.1 REV 3 20442 28.0.1 REV 3 24027 28.0.1 REV 3 26432 28.0.1 REV 3 27592 28.0.1 REV 3 27743 28.0.1 REV 3 12049304 28.0.1 REV 3 15994 28.0.1 REV 3 28107 28.0.1 REV 3 12048078 28.0.1 REV 3 12060766 28.0.1 REV 3 18229 28.0.1 REV 3 22233 28.0.1 REV 3 23497 28.0.1 REV 3 25921 28.0.1 REV 3 30275 28.0.1 REV 3 12043589 28.0.1 REV 3 12044455 28.0.1 REV 3 18130 28.0.1 REV 3 23380 28.0.1 REV 3 23707 28.0.1 REV 3 12051098 28.0.1 REV 3 12055293 28.0.1 REV 3 20896 28.0.1 REV 3 23664 28.0.1 REV 3 27681 28.0.1 REV 3 12041300 28.0.1 REV 3 12044249 28.0.1 REV 3 12044699 28.0.1 REV 3 12051081 28.0.1 REV 3 12054754 28.0.1 REV 3 12055190 28.0.1 REV 3 12055550 28.0.1 REV 3 12398 28.0.1 REV 3 14676 28.0.1 REV 3 15073 28.0.1 REV 3 18068 28.0.1 REV 3 25127 28.0.1 REV 3 12042011 28.0.1 REV 3 12045140 28.0.1 REV 3 12045872 28.0.1 REV 3 12046244 28.0.1 REV 3 12052159 28.0.1 REV 3 12061378 28.0.1 REV 3 11790 28.0.1 REV 3 22079 28.0.1 REV 3 22797 28.0.1 REV 3 24471 28.0.1 REV 3 25938 28.0.1 REV 3 25968 28.0.1 REV 3 12041308 28.0.1 REV 3 12042662 28.0.1 REV 3 12045013 28.0.1 REV 3 12045721 28.0.1 REV 3 12048202 28.0.1 REV 3 12052134 28.0.1 REV 3 12054714 28.0.1 REV 3 12060802 28.0.1 REV 3 12469 28.0.1 REV 3 23798 28.0.1 REV 3 24089 28.0.1 REV 3 30709 28.0.1 REV 3 12044994 28.0.1 REV 3 12049444 28.0.1 REV 3 12051334 28.0.1 REV 3 11854 28.0.1 REV 3 17005 28.0.1 REV 3 19258 28.0.1 REV 3 21172 28.0.1 REV 3 23439 28.0.1 REV 3 24825 28.0.1 REV 3 27910 28.0.1 REV 3 12041331 28.0.1 REV 3 12043679 28.0.1 REV 3 12044986 28.0.1 REV 3 12048439 28.0.1 REV 3 12052263 28.0.1 REV 3 16702 28.0.1 REV 3 12044642 28.0.1 REV 3 12048466 28.0.1 REV 3 12060668 28.0.1 REV 3 15187 28.0.1 REV 3 23268 28.0.1 REV 3 24507 28.0.1 REV 3 12044610 28.0.1 REV 3 12052087 28.0.1 REV 3 12060663 28.0.1 REV 3 11863 28.0.1 REV 3 13959 28.0.1 REV 3 17266 28.0.1 REV 3 17741 28.0.1 REV 3 20356 28.0.1 REV 3 23582 28.0.1 REV 3 24413 28.0.1 REV 3 24972 28.0.1 REV 3 25773 28.0.1 REV 3 26112 28.0.1 REV 3 28029 28.0.1 REV 3 30012 28.0.1 REV 3 12050063 28.0.1 REV 3 15955 28.0.1 REV 3 25761 28.0.1 REV 3 26739 28.0.1 REV 3 30793 28.0.1 REV 3 12049901 28.0.1 REV 3 12051664 28.0.1 REV 3 12055810 28.0.1 REV 3 25265 28.0.1 REV 3 12055902 28.0.1 REV 3 22214 28.0.1 REV 3 22314 28.0.1 REV 3 12045485 28.0.1 REV 3 20005 28.0.1 REV 3 12046761 28.0.1 REV 3 12041886 28.0.1 REV 3 15004 28.0.1 REV 3 14988 28.0.1 REV 3 15513 28.0.1 REV 3 12381 28.0.1 REV 3 27344 28.0.1 REV 3 17640 28.0.1 REV 3 20222 28.0.1 REV 3 12429 28.0.1 REV 3 12044445 28.0.1 REV 3 19395 28.0.1 REV 3 26455 28.0.1 REV 3 19154 28.0.1 REV 3 12055956 28.0.1 REV 3 12041978 28.0.1 REV 3 12056082 28.0.1 REV 3 12042687 28.0.1 REV 3 27966 28.0.1 REV 3 14911 28.0.1 REV 3 17551 28.0.1 REV 3 12047002 28.0.1 REV 3 17462 28.0.1 REV 3 12055923 28.1.1 REV 1 18003 28.1.1 REV 1 19608 28.1.1 REV 1 23031 28.1.1 REV 1 25892 28.1.1 REV 1 12047062 28.1.1 REV 1 12053048 28.1.1 REV 1 12060701 28.1.1 REV 1 12310 28.1.1 REV 1 13817 28.1.1 REV 1 18019 28.1.1 REV 1 12043395 28.1.1 REV 1 12044648 28.1.1 REV 1 12045608 28.1.1 REV 1 12052959 28.1.1 REV 1 12053251 28.1.1 REV 1 12054669 28.1.1 REV 1 11819 28.1.1 REV 1 12152 28.1.1 REV 1 12206 28.1.1 REV 1 15031 28.1.1 REV 1 15476 28.1.1 REV 1 17871 28.1.1 REV 1 17912 28.1.1 REV 1 22167 28.1.1 REV 1 23984 28.1.1 REV 1 25969 28.1.1 REV 1 26712 28.1.1 REV 1 12040705 28.1.1 REV 1 12040809 28.1.1 REV 1 12042039 28.1.1 REV 1 12044422 28.1.1 REV 1 12048164 28.1.1 REV 1 12051084 28.1.1 REV 1 12051382 28.1.1 REV 1 12052034 28.1.1 REV 1 12052050 28.1.1 REV 1 12053203 28.1.1 REV 1 12005 28.1.1 REV 1 12564 28.1.1 REV 1 25820 28.1.1 REV 1 26419 28.1.1 REV 1 12042211 28.1.1 REV 1 12045204 28.1.1 REV 1 12045683 28.1.1 REV 1 12052633 28.1.1 REV 1 12256 28.1.1 REV 1 13627 28.1.1 REV 1 15312 28.1.1 REV 1 17877 28.1.1 REV 1 18020 28.1.1 REV 1 21117 28.1.1 REV 1 27039 28.1.1 REV 1 27673 28.1.1 REV 1 27913 28.1.1 REV 1 12041851 28.1.1 REV 1 12042084 28.1.1 REV 1 12046961 28.1.1 REV 1 12048566 28.1.1 REV 1 12051078 28.1.1 REV 1 12053189 28.1.1 REV 1 14952 28.1.1 REV 1 18057 28.1.1 REV 1 19093 28.1.1 REV...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA, WI, and WV. The countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 1, 2025
Recall initiation date: Nov 21, 2024
Center classification date: Dec 23, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records