510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0643-2024Class II

Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/...

Bard Peripheral Vascular Inc / initiated 2023-11-08 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Bard Peripheral Vascular Inc began a recall of Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x... on . FDA classified it as Class II and gives the reason as "The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0643-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Bard Peripheral Vascular Inc
Product
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM
Product code
KNW Instrument, Biopsy
Reason for recall
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
On 11/8/23, recall notices were distributed to customers and distributors who were asked to do the following: 1) Discontinue use of affected product, and immediately dispose of all affected product remaining in your possession in accordance with your local facility's process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this recall. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. - Distributors were asked to Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this expanded field action notification. 3) Complete and return the attached Customer Response Form via email to [email protected] Customers requiring additional assistance can contact the firm's North American Regional Complaint Center by phone: 1-844-823-5433, say "recall" when prompted M-F 8am - 5pm CT, or via email: [email protected]
Quantity in commerce
1,243,937
Distribution
Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL, ID, IN, AL, VA, CO, WI, NY, NV, OK, OH, WA, MI, MS, AZ, HI, SD, NJ, NE, MT, NC, DC, CT, WY, UT, TN, LA, NM, SC, VT, MO, ME, AR, OR, KS, RI, AK, WV, DE, ND, PR, GU and the countries of CA, BE, AU, KR, SG, CN, TH, HK, VI, VN, AR, JP, CL, IN, TW, CO, MX, DO, BR, BD, MM, PK, NP, PA.
Product codes and lots
REF/UDI-DI/Lot (Expiration Date): 1410MSK/ 00801741142543/ 0001418630(05/28/24), 0001429851(07/28/24), 0001433778(08/28/24), 0001441794(10/28/24), 0001443076(10/28/24, 0001446454(11/28/24, 0001451131(01/28/25, 0001452840(01/28/25, 0001463142(03/28/25, 0001468867(04/28/25, 0001475757(06/28/25, 0001481508(07/28/25, 0001485193(08/28/25, 0001487094(08/28/25, 0001488512(08/28/25, 0001491080(09/28/25, 0001491583(09/28/25, 0001498859(11/28/25, 0001502349(12/28/25); 1416MSK/ 00801741142550/0001402196(01/28/24), 0001423061(06/28/24), 0001430525(07/28/24), 0001434059(08/28/24), 0001435619(09/28/24), 0001452376(01/28/25), 0001458437(02/28/25), 0001464693(03/28/25), 0001464694(03/28/25); 1610MSK/ 00801741142567/0001390419(10/28/23), 0001392740(10/28/23), 0001402197(01/28/24), 0001415815(04/28/24), 0001418632(05/28/24), 0001426735(06/28/24), 0001426839(07/28/24), 0001430408(07/28/24), 0001430528(07/28/24), 0001433779(08/28/24), 0001468480(04/28/25), 0001468479(04/28/25), 0001474221(05/28/25), 0001478981(06/28/25), 0001481036(07/28/25), 0001481035(07/28/25), 0001480804(07/28/25), 0001480805(07/28/25), 0001485185(08/28/25), 0001487093(08/28/25), 0001486540(08/28/25), 0001491078(09/28/25), 0001502344(12/28/25); 1616MSK/ 00801741142574/0001410073(02/28/24), 0001418633(05/28/24), 0001429719(07/28/24), 0001432764(08/28/24), 0001441990(10/28/24), 0001445629(11/28/24), 0001451613(01/28/25), 0001468728(04/28/25), 0001474220(05/28/25), 0001474506(05/28/25), 0001476311(06/28/25), 0001480541(07/28/25), 0001480542(07/28/25), 0001498110(11/28/25); 1810MSK/ 00801741097058/0001390415(10/28/23), 0001390414(10/28/23), 0001392714(10/28/23), 0001393862(10/28/23), 0001394226(10/28/23), 0001394535(10/28/23), 0001398597(12/28/23), 0001398596(12/28/23), 0001399830(12/28/23), 0001398961(12/28/23), 0001400410(12/28/23), 0001400409(12/28/23), 0001402163(01/28/24), 0001402164(01/28/24), 0001402165(01/28/24), 0001411232(03/28/24), 0001412043(03/28/24), 0001412042(03/28/24), 0001412044(03/28/24), 0001411871(03/28/24), 0001411233(03/28/24), 0001415831(04/28/24), 0001415832(04/28/24), 0001415833(04/28/24), 0001418634(05/28/24), 0001418637(05/28/24), 0001418638(05/28/24), 0001418639(05/28/24), 0001418635(05/28/24), 0001423157(06/28/24), 0001423153(06/28/24), 0001423889(06/28/24), 0001423818(06/28/24), 0001425382(06/28/24), 0001425996(06/28/24), 0001427153(07/28/24), 0001427154(07/28/24), 0001427151(07/28/24), 0001427971(07/28/24), 0001428062(07/28/24), 0001428063(07/28/24), 0001428595(07/28/24), 0001428594(07/28/24), 0001428593(07/28/24), 0001432766(08/28/24), 0001432765(08/28/24), 0001435553(09/28/24), 0001435552(09/28/24), 0001436593(09/28/24), 0001436594(09/28/24), 0001436596(09/28/24), 0001437223(09/28/24), 0001439097(10/28/24), 0001439098(10/28/24), 0001440545(10/28/24), 0001440550(10/28/24), 0001440546(10/28/24), 0001440547(10/28/24), 0001440548(10/28/24), 0001441274(10/28/24), 0001441333(10/28/24), 0001441334(10/28/24), 0001442964(10/28/24), 0001442322(10/28/24), 0001444346(11/28/24), 0001444344(11/28/24), 0001444348(11/28/24), 0001444345(11/28/24), 0001445638(11/28/24), 0001444347(11/28/24), 0001448511(12/28/24), 0001448510(12/28/24), 0001448509(12/28/24), 0001448508(12/28/24), 0001448746(12/28/24), 0001448745(12/28/24), 0001450208(12/28/24), 0001450000(12/28/24), 0001452266(01/28/25), 0001452380(01/28/25), 0001452267(01/28/25), 0001457033(02/28/25), 0001457034(02/28/25), 0001458731(02/28/25), 0001458730(02/28/25), 0001459349(02/28/25), 0001458728(02/28/25), 0001458729(02/28/25), 0001460530(03/28/25), 0001465424(04/28/25), 0001465423(04/28/25), 0001465703(04/28/25), 0001465704(04/28/25), 0001466004(04/28/25), 0001466003(04/28/25), 0001466075(04/28/25), 0001465493(04/28/25), 0001465883(04/28/25), 0001465491(04/28/25), 0001465492(04/28/25), 0001467088(04/28/25), 0001465882(04/28/25), 0001467181(04/28/25), 0001467180(04/28/25), 0001468726(04/28/25), 0001470276(05/28/25), 0001470007(05/28/25), 0001469995(05/28/25), 0001473075(05/28/25), 0001473604(05/28/25), 0001470254(05/28/25), 0001473043(05/28/25), 0001473602(05/28/25), 0001473603(05/28/25), 0001474075(05/28/25), 0001475710(06/28/25), 0001477992(06/28/25), 0001477987(06/28/25), 0001477993(06/28/25), 0001477990(06/28/25), 0001475711(06/28/25), 0001477985(06/28/25), 0001478765(06/28/25), 0001478764(06/28/25), 0001478960(06/28/25), 0001478959(06/28/25), 0001479238(06/28/25), 0001478581(06/28/25), 0001481263(07/28/25), 0001481261(07/28/25), 0001482202(07/28/25), 0001481262(07/28/25), 0001482322(07/28/25), 0001483661(07/28/25), 0001483662(07/28/25), 0001486541(08/28/25), 0001487721(08/28/25), 0001487089(08/28/25), 0001487722(08/28/25), 0001487720(08/28/25), 0001488976(08/28/25), 0001488974(08/28/25), 0001488975(08/28/25), 0001486542(08/28/25), 0001490113(09/28/25), 0001490114(09/28/25), 0001490116(09/28/25), 0001490112(09/28/25), 0001490117(09/28/25), 0001490115(09/28/25), 0001490739(09/28/25), 0001490738(09/28/25), 0001491038(09/28/25), 0001490742(09/28/25), 0001491039(09/28/25), 0001491021(09/28/25), 0001490741(09/28/25), 0001491022(09/28/25), 0001492549(09/28/25), 0001494131(10/28/25), 0001494132(10/28/25), 0001494195(10/28/25), 0001494843(10/28/25), 0001494841(10/28/25), 0001494844(10/28/25), 0001494842(10/28/25), 0001497923(10/28/25), 0001497741(10/28/25), 0001497740(10/28/25), 0001497925(10/28/25), 0001497739(10/28/25), 0001497924(11/28/25), 0001499062(11/28/25), 0001501269(12/28/25), 0001501273(12/28/25), 0001501270(12/28/25), 0001501272(12/28/25), 0001501263(12/28/25), 0001501267(12/28/25), 0001501271(12/28/25), 0001501264(12/28/25), 0001501268(12/28/25), 0001501265(12/28/25), 0001501266(12/28/25), 0001503385(12/28/25), 0001503382(12/28/25), 0001503384(12/28/25); 1816MSK/00801741097065/ 0001390396(10/28/23), 0001390397(10/28/23), 0001390398(10/28/23), 0001392710(10/28/23), 0001393863(10/28/23), 0001394534(10/28/23), 0001396998(11/28/23), 0001396999(11/28/23), 0001398599(12/28/23), 0001398919(12/28/23), 0001398598(12/28/23), 0001400412(12/28/23), 0001400411(12/28/23), 0001402168(01/28/24), 0001402166(01/28/24), 0001402167(01/28/24), 0001410074(02/28/24), 0001411878(03/28/24), 0001411882(03/28/24), 0001411879(03/28/24), 0001412690(03/28/24), 0001412691(03/28/24), 0001412693(03/28/24), 0001413032(03/28/24), 0001413033(03/28/24), 0001415838(04/28/24), 0001415839(04/28/24), 0001415835(04/28/24), 0001415841(04/28/24), 0001415837(04/28/24), 0001415840(04/28/24), 0001418554(05/28/24), 0001418649(05/28/24), 0001418644(05/28/24), 0001418646(05/28/24), 0001418645(05/28/24), 0001418648(05/28/24), 0001418647(05/28/24), 0001418643(05/28/24), 0001422221(05/28/24), 0001422328(05/28/24), 0001423158(06/28/24), 0001423160(06/28/24), 0001423159(06/28/24), 0001425987(06/28/24), 0001425990(06/28/24), 0001425989(06/28/24), 0001427603(07/28/24), 0001427607(07/28/24), 0001427610(07/28/24), 0001427617(07/28/24), 0001427609(07/28/24), 0001428585(07/28/24), 0001428587(07/28/24), 0001428586(07/28/24), 0001429849(07/28/24), 0001430932(07/28/24), 0001429850(07/28/24), 0001431200(08/28/24), 0001431199(08/28/24), 0001436070(09/28/24), 0001437562(09/28/24), 0001437563(09/28/24), 0001439251(10/28/24), 0001440554(10/28/24), 0001440555(10/28/24), 0001440557(10/28/24), 0001439252(10/28/24), 0001440552(10/28/24), 0001441545(10/28/24), 0001441546(10/28/24), 0001441548(10/28/24), 0001441547(10/28/24), 0001442311(10/28/24), 0001442308(10/28/24), 0001442310(10/28/24), 0001442307(10/28/24), 0001443670(11/28/24), 0001443662(11/28/24), 0001443660(11/28/24), 0001443661(11/28/24), 0001443659(11/28/24), 0001443658(11/28/24), 0001460536(03/28/25), 0001460525(03/28/25), 0001462195(03/28/25), 0001460526(03/28/25), 0001462867(03/28/25), 0001460521(03/28/25), 0001462866(03/28/25), 0001463988(03/28/25), 0001463586(03/28/25), 0001463987(03/28/25), 0001465104(03/28/25), 0001467002(04/28/25), 0001467001(04/28/25), 0001468229(04/28/25), 0001468230(04/28/25), 0001468228(04/28/25), 0001468231(04/28/25), 0001469728(04/28/25), 0001469729(04/28/25), 0001469758(04/28/25), 0001469759(04/28/25), 0001474077(05/28/25), 0001474076(05/28/25), 0001474218(05/28/25), 0001474573(05/28/25), 0001474572(05/28/25), 0001474768(05/28/25), 0001474767(05/28/25), 0001474980(05/28/25), 0001476218(06/28/25), 0001477154(06/28/25), 0001477155(06/28/25), 0001477156(06/28/25), 0001481268(07/28/25), 0001481270(07/28/25), 0001481523(07/28/25), 0001481520(07/28/25), 0001481269(07/28/25), 0001481521(07/28/25), 0001481522(07/28/25), 0001485403(08/28/25), 0001485404(08/28/25), 0001485405(08/28/25), 0001485406(08/28/25), 0001486548(08/28/25), 0001486547(08/28/25), 0001486910(08/28/25), 0001487344(08/28/25), 0001488715(08/28/25), 0001489811(09/28/25), 0001489812(09/28/25), 0001490109(09/28/25), 0001490110(09/28/25), 0001490108(09/28/25), 0001490107(09/28/25), 0001491313(09/28/25), 0001491314(09/28/25), 0001491315(09/28/25), 0001491774(09/28/25), 0001491316(09/28/25), 0001491773(09/28/25), 0001493542(09/28/25), 0001493543(09/28/25), 0001493686(09/28/25), 0001493685(09/28/25), 0001493818(10/28/25), 0001494200(10/28/25), 0001494203(10/28/25), 0001494204(10/28/25), 0001494201(10/28/25), 0001494836(10/28/25), 0001494202(10/28/25), 0001494838(10/28/25), 0001494198(10/28/25), 0001494196(10/28/25), 0001494837(10/28/25), 0001494197(10/28/25), 0001494199(10/28/25), 0001495250(10/28/25), 0001494835(10/28/25), 0001495244(10/28/25), 0001495251(10/28/25), 0001495247(10/28/25), 0001495248(10/28/25), 0001495253(10/28/25), 0001495245(10/28/25), 0001495971(10/28/25), 0001496079(10/28/25), 0001496078(10/28/25), 0001495252(10/28/25), 0001495973(10/28/25), 0001495970(10/28/25), 0001496387(10/28/25), 0001495972(10/28/25), 0001495969(10/28/25), 0001496384(10/28/25), 0001496389(10/28/25), 0001496386(10/28/25), 0001496565(10/28/25), 0001497084(10/28/25), 0001496954(10/28/25), 0001496956(10/28/25), 0001496385(10/28/25), 0001496955(10/28/25), 0001496566(10/28/25), 0001497352(11/28/25), 0001497353(11/28/25), 0001498289(11/28/25), 0001498290(11/28/25), 0001498291(11/28/25), 0001499112(11/28/25), 0001499666(11/28/25), 0001499665(11/28/25), 0001499111(11/28/25), 0001499109(11/28/25), 0001499108(11/28/25), 0001499745(11/28/25), 0001499746(11/28/25), 0001499748(11/28/25), 0001499742(11/28/25), 0001500140(11/28/25), 0001500386(11/28/25), 0001500385(11/28/25), 0001499744(11/28/25), 0001500888(11/28/25), 0001500890(11/28/25), 0001500891(11/28/25), 0001501017(11/28/25),0001501018(11/28/25), 0001501247(12/28/25), 0001447510(12/28/24), 0001447511(12/28/24), 0001447513(12/28/24), 0001447512(12/28/24), 0001448119(12/28/24), 0001448118(12/28/24), 0001448121(12/28/24), 0001448120(12/28/24), 0001448743(12/28/24), 0001450414(12/28/24), 0001450413(12/28/24), 0001451076(01/28/25), 0001451075(01/28/25), 0001451625(01/28/25), 0001451626(01/28/25), 0001451621(01/28/25), 0001451622(01/28/25), 0001453517(01/28/25), 0001453516(01/28/25), 0001454295(01/28/25), 0001457030(02/28/25), 0001456850(02/28/25), 0001456856(02/28/25); 1820MSK/ 00801741097072/0001390395(10/28/23), 0001393302(10/28/23), 0001395412(11/28/23), 0001399924(12/28/23), 0001398970(12/28/23), 0001402194(01/28/24), 0001412041(03/28/24), 0001412040(03/28/24), 0001414697(04/28/24), 0001414698(04/28/24), 0001415131(04/28/24), 0001415130(04/28/24), 0001418624(05/28/24), 0001422573(05/28/24), 0001422798(06/28/24), 0001424731(06/28/24), 0001435536(09/28/24), 0001435620(09/28/24), 0001439254(10/28/24), 0001439255(10/28/24), 0001439256(10/28/24), 0001443406(11/28/24), 0001443409(11/28/24), 0001449979(12/28/24), 0001458050(02/28/25), 0001458051(02/28/25), 0001461273(03/28/25), 0001464301(03/28/25), 0001464468(03/28/25), 0001465731(04/28/25), 0001476033(06/28/25), 0001476034(06/28/25), 0001476035(06/28/25), 0001477256(06/28/25), 0001480266(07/28/25), 0001480368(07/28/25), 0001480369(07/28/25), 0001487716(08/28/25), 0001488502(08/28/25), 0001487718(08/28/25), 0001487719(08/28/25), 0001489904(09/28/25), 0001489890(09/28/25), 0001489891(09/28/25), 0001493060(09/28/25), 0001490111(09/28/25), 0001496111(10/28/25), 0001496110(10/28/25), 0001498327(11/28/25), 0001498326(11/28/25), 0001500878(11/28/25), 0001502903(12/28/25), 0001504427(12/28/25); 1825MSK/ 00801741142581/0001440070(10/28/24), 0001443305(11/28/24), 0001455151(01/28/25), 0001480267(07/28/25), 0001498155(11/28/25), 0001502905(12/28/25); 2010MSK/00801741097089/ 0001390416(10/28/23), 0001392742(10/28/23), 0001395411(11/28/23), 0001398976(12/28/23), 0001402093(01/28/24), 0001414353(03/28/24), 0001414355(03/28/24), 0001412036(03/28/24), 0001414683(04/28/24), 0001415823(04/28/24), 0001415822(04/28/24), 0001418626(05/28/24), 0001420606(05/28/24), 0001423813(06/28/24), 0001427149(07/28/24), 0001430092(07/28/24), 0001430336(07/28/24), 0001430524(07/28/24), 0001432741(08/28/24), 0001437858(09/28/24), 0001442202(10/28/24), 0001445947(11/28/24), 0001445948(11/28/24), 0001445945(11/28/24), 0001448749(12/28/24), 0001448750(12/28/24), 0001448747(12/28/24), 0001448748(12/28/24)0001449432(12/28/24), 0001449433(12/28/24), 0001456597(02/28/25), 0001456153(02/28/25), 0001456573(02/28/25), 0001456936(02/28/25), 0001456596(02/28/25),0001459554(02/28/25),0001461729(03/28/25), 0001461728(03/28/25), 0001462125(03/28/25), 0001475009(05/28/25), 0001475008(05/28/25), 0001478968(06/28/25), 0001478963(06/28/25), 0001479643(06/28/25), 0001479644(06/28/25), 0001482928(07/28/25), 0001482931(07/28/25), 0001482930(07/28/25), 0001482932(07/28/25), 0001482929(07/28/25), 0001482934(07/28/25), 0001488082(08/28/25), 0001487710(08/28/25), 0001487711(08/28/25), 0001487602(08/28/25), 0001488510(08/28/25), 0001488081(08/28/25), 0001490705(09/28/25), 0001490708(09/28/25), 0001490706(09/28/25), 0001498139(11/28/25), 0001498140(11/28/25), 0001503043(12/28/25), 0001503044(12/28/25), 0001504002(12/28/25), 0001503958(12/28/25), 0001445946(11/28/24); 2016MSK/ 00801741097096/0001390417(10/28/23), 0001390418(10/28/23), 0001392738(10/28/23), 0001394806(11/28/23), 0001395410(11/28/23), 0001398980(12/28/23), 0001398979(12/28/23), 0001401523(12/28/23), 0001401520(12/28/23), 0001402087(01/28/24), 0001402086(01/28/24), 0001415824(04/28/24), 0001415826(04/28/24), 0001418627(05/28/24), 0001418628(05/28/24), 0001423816(06/28/24), 0001423815(06/28/24), 0001428803(07/28/24), 0001428592(07/28/24), 0001429954(07/28/24), 0001430089(07/28/24), 0001430339(07/28/24), 0001432740(08/28/24), 0001432739(08/28/24), 0001434756(08/28/24), 0001437864(09/28/24), 0001441795(10/28/24), 0001441796(10/28/24), 0001442314(10/28/24), 0001442315(10/28/24), 0001442313(10/28/24), 0001442312(10/28/24), 0001445803(11/28/24), 0001445944(11/28/24), 0001445802(11/28/24), 0001445801(11/28/24), 0001448753(12/28/24), 0001448752(12/28/24),0001450642(12/28/24), 0001450646(12/28/24), 0001450644(12/28/24), 0001453528(01/28/25), 0001453530(01/28/25), 0001453529(01/28/25), 0001454098(01/28/25), 0001456155(02/28/25), 0001456154(02/28/25), 0001457603(02/28/25), 0001457602(02/28/25), 0001458843(02/28/25), 0001469201(04/28/25), 0001469202(04/28/25), 0001469200(04/28/25), 0001469577(04/28/25), 0001475585(05/28/25), 0001475411(05/28/25), 0001475410(05/28/25), 0001475412(05/28/25), 0001476363(06/28/25), 0001476364(06/28/25), 0001478962(06/28/25), 0001478961(06/28/25), 0001480801(07/28/25), 0001483581(07/28/25), 0001483582(07/28/25), 0001486538(08/28/25), 0001487713(08/28/25), 0001486539(08/28/25), 0001489271(08/28/25), 0001489612(08/28/25), 0001487714(08/28/25), 0001492480(09/28/25), 0001492475(09/28/25), 0001492477(09/28/25), 0001492478(09/28/25), 0001492479(09/28/25), 0001492476(09/28/25), 0001495451(10/28/25), 0001497095(10/28/25), 0001497094(10/28/25), 0001497674(10/28/25), 0001497354(10/28/25), 0001498772(11/28/25), 0001499753(11/28/25), 0001499751(11/28/25), 0001499752(11/28/25), 0001500387(11/28/25), 0001503045(12/28/25), 0001503830(12/28/25), 0001503828(12/28/25), 0001503046(12/28/25), 0001503829(12/28/25), 0001458844(02/28/25); 2020MSK/ 00801741097102/0001412035(03/28/24), 0001414700(04/28/24), 0001415128(04/28/24), 0001422837(06/28/24), 0001425299(06/28/24), 0001425389(06/28/24), 0001435087(09/28/24), 0001439257(10/28/24), 0001443304(11/28/24), 0001451614(01/28/25), 0001463280(03/28/25), 0001464594(03/28/25), 0001469727(04/28/25), 0001469431(04/28/25), 0001469767(04/28/25), 0001469768(04/28/25), 0001471378(05/28/25), 0001487723(08/28/25), 0001491546(09/28/25), 0001492487(09/28/25), 0001494059(09/28/25), 0001499269(11/28/25), 0001504259(12/28/25)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0643-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0643-2024Class IIOngoingVoluntary: Firm initiated