Recalls affecting Maryland

FDA has not published a risk classification for this recall yet.

Recall #:

84309

Lot/product code:

Serial Numbers: 13101261

Recalling firm:

Villa Sistemi Medicali S.P.A.

FDA has not published a risk classification for this recall yet.

Recall #:

84309

Lot/product code:

Serial Numbers: 08020473 11100873 15041446

Recalling firm:

Villa Sistemi Medicali S.P.A.

FDA has not published a risk classification for this recall yet.

Recall #:

85416

Lot/product code:

Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.

Recalling firm:

Shimadzu Medical Systems

FDA has not published a risk classification for this recall yet.

Recall #:

84309

Lot/product code:

Serial Numbers: 08090531 09090591 10040680 15051450 11020798 17011602 17041639

Recalling firm:

Villa Sistemi Medicali S.P.A.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0527-2020

Lot/product code:

RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021

Recalling firm:

AuroMedics Pharma LLC

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0530-2020

Lot/product code:

RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021

Recalling firm:

AuroMedics Pharma LLC

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0526-2020

Lot/product code:

Lot # NBSB19001DA3; Exp FEB 2021

Recalling firm:

AuroMedics Pharma LLC

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0528-2020

Lot/product code:

RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021

Recalling firm:

AuroMedics Pharma LLC

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0529-2020

Lot/product code:

UI1519001-A UI1519002-A UI1519003-A UI1519004-A

Recalling firm:

AuroMedics Pharma LLC

FDA has not published a risk classification for this recall yet.

Recall #:

90484

Lot/product code:

UDI-DI (GTIN): 04046963419639

Recalling firm:

Aesculap Implant Systems LLC

FDA has not published a risk classification for this recall yet.

Recall #:

84352

Lot/product code:

Lot codes: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, 70123853, 70129395, 7011472 05, 70121444, 70123849, 70124474, 70124529, 70124694, 70127498, 70131871, 70124527, 70113694, 70120282, 70121445, 70123850, 70124525, 70124689, 70124695, 70127499, 70120470, 70124692, 70120283, 70121668, 70123852, 70124526, 70124691, 70124696, 70128623, 70122004, 70127335  UDI Code: 04037691670164

Recalling firm:

GETINGE US SALES LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86647

Lot/product code:

a) 1GE512055-40: 20170042941, 20170042942, 20170042943, 20170042944, 20170042945, 20170042946, 20170043764, 20170043765, 20170043766, 20170043767, 20170043768, 20170043769, 20170043770, 20170043771, 20170043772, 20170043773, 20170043774, 20170043775  b) 1GE512055-45: 20170055478, 20170055479, 20170055480, 20170055481, 20170055482, 20170055483, 20170055484, 20170055485, 20170055486, 20170055487, 20170055488, 20170055489, 20170055490, 20170056038, 20170056039, 20170056040, 20170056041, 20170056042, 20170056043, 20170056044, 20170056045, 20170056046, 20170056047, 20170056048, 20170056049, 20170056050, 20170056051, 20170056052, 20170056053, 20170056054, 20170056055, 20170056056, 20170056527, 20170056528, 20170056529, 20170056530, 20170056531, 20170056532, 20170056533, 20170056534, 20170056535, 20170056536, 20170056537, 20170056538, 20170056539, 20170056540, 20170056541, 20170056542, 20170056543, 20170056544, 20170056545, 20170056546, 20170058170, 20170058171, 20170058172, 20170058173, 20170058174, 20170058175, 20170058176, 20170058177, 20170058178, 20170058179, 20170058180, 20170058181, 20170058182, 20170058183, 20170058184, 20170058185, 20170058186, 20170058187, 20170058188, 20170058189, 20170058190, 20170058191, 20170058192, 20170058193, 20170058194, 20170058195, 20170059025, 20170059026, 20170059027, 20170059028, 20170059029, 20170059030, 20170059031, 20170059032, 20170059033, 20170059034, 20170059035, 20170059036, 20170059037, 20170059038, 20170059039, 20170059040, 20170059041, 20170059042, 20170059043, 20170059044, 20170059045, 20170059046, 20170059047, 20170059048, 20170059049, 20170059050, 20170059316, 20170059317, 20170059318, 20170059319, 20170059320, 20170059321, 20170059322, 20170059323, 20170059324, 20170059325, 20170059326, 20170059327, 20170059328, 20170060129, 20170060130, 20170060131, 20170060132, 20170060133, 20170060134, 20170060135, 20170060136, 20170060137, 20170060138, 20170060139, 20170060140, 20170060141, 20170060142, 20170060143, 20170060144, 20170060145, 20170060146, 20170060147, 20170060148, 20170060149, 20170060150, 20170060151, 20170060152, 20170060153, 20170060154, 20170061737, 20170061738, 20170061739, 20170061740, 20170061741, 20170061742, 20170061743, 20170061744, 20170061745, 20170061746, 20170061747, 20170061748, 20170061749, 20170061750, 20170061751, 20170061752, 20170061753, 20170061754, 20170061755, 20170061756, 20170061757, 20170061758, 20170061759, 20170061760, 20170061761, 20170061762, 20170063084, 20170063085, 20170063086, 20170063087, 20170063088, 20170063089, 20170063090, 20170063091, 20170063092, 20170063093, 20170063094, 20170063095, 20170063096, 20170064049, 20170064050, 20170064051, 20170064052, 20170064053, 20170064054, 20170064055, 20170064056, 20170064057, 20170064058, 20170064059, 20170064060, 20170064061, 20170064062, 20170064063, 20170064064, 20170064065, 20170064066  c) 1GE512055-85: 20180190190, 20180190191, 20180190192, 20180190193, 20180190194, 20180190195, 20180190196, 20180190197, 20180190198, 20180190199, 20180190200, 20180190201, 20180190202, 20180190203, 20180190204, 20180190205, 20180190206, 20180190207, 20180190208, 20180190209, 20180190210, 20180190211, 20180190212, 20180190213, 20180190214, 20180190215, 20180190216, 20180190217, 20180190218, 20180190219, 20180190914, 20180190915, 20180190916, 20180190917, 20180190918, 20180190919, 20180190920, 20180190921, 20180190922, 20180190923, 20180190924, 20180190925, 20180190926, 20180190927, 20180190928, 20180190929, 20180190930, 20180190931, 20180190932, 20180190933, 20180190934, 20180190935, 20180190936, 20180190937, 20180190938, 20180190939, 20180190940, 20180190941, 20180190942, 20180190943, 20180191864, 20180191865, 20180191866, 20180191867, 20180191868, 20180191869, 20180191870, 20180191871, 20180191872, 20180191873, 20180191874, 20180191875, 20180191876, 20180191877, 20180191878, 20180191879, 20180191880, 20180191881, 20180191882, 20180191883, 20180191884, 20180191885, 20180191886, 20180191887, 20180191888, 20180191889, 20180191890, 20180191891, 20180191892, 20180191893, 20180193407, 20180193408, 20180193409, 20180193410, 20180193411, 20180193412, 20180193413, 20180193414, 20180193415, 20180193416, 20180193417, 20180193418, 20180193419, 20180193420, 20180193421, 20180193428, 20180193429, 20180193430, 20180193431, 20180193432, 20180193433, 20180193434, 20180193435, 20180193436, 20180193437, 20180193438, 20180193439, 20180193440, 20180193441, 20180193442  d) 1GE512055-95: 20170114725, 20170116005, 20170116006, 20170116007, 20170116008, 20170116009, 20170116010, 20170116011, 20170116012, 20170116013, 20170116014, 20170116015, 20170116016, 20170116017, 20170116018, 20170116019, 20170116020, 20170116021, 20170116022, 20170116023, 20170116024, 20170116025, 20170116026, 20170116027, 20170116028, 20170116029, 20170116030, 20170116031, 20170116032, 20170116033, 20170116034, 20170116035, 20170116036, 20170116037, 20170116038, 20170116039, 20170116040, 20170116041, 20170116042, 20170116043, 20170116044, 2… (truncated, 11354 characters total — see the official FDA record for the full value)

Recalling firm:

Linet Spol. S.r.o.

FDA has not published a risk classification for this recall yet.

Recall #:

84332

Lot/product code:

UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170

Recalling firm:

Medtronic Xomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84332

Lot/product code:

UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918

Recalling firm:

Medtronic Xomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84332

Lot/product code:

UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438

Recalling firm:

Medtronic Xomed, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84228

Lot/product code:

All Lot Codes. Affected SKUs: C06020MB, C06020MV, C06020SB, C06020SV, C06030MB, C06030MV, C06030SB, C06030SV, C06040MB, C06040MV, C06040SB, C06040SV, C06060MB, C06060MV, C06060SB, C06060SV, C06080MB, C06080MV, C06080SB, C06080SV, C06100MB, C06100MV, C06100SB, C06100SV, C07020MB, C07020MV, C07020SB, C07020SV, C07030MB, C07030MV, C07030SB, C07030SV, C07040MB, C07040MV, C07040SB, C07040SV, C07060MB, C07060MV, C07060SB, C07060SV, C07080MB, C07080MV, C07080SB, C07080SV, C07100MB, C07100MV, C07100SB, C07100SV, C08020MB, C08020MV, C08020SB, C08020SV, C08030MB, C08030MV, C08030SB, C08030SV, C08040MB, C08040MV, C08040SB, C08040SV, C08060MB, C08060MV, C08060SB, C08060SV, C08080MB, C08080MV, C08080SB, C08080SV, C08100MB, C08100MV, C08100SB, C08100SV, C09020MB, C09020MV, C09020SB, C09020SV, C09030MB, C09030MV, C09030SB, C09030SV, C09040MB, C09040MV, C09040SB, C09040SV, C09060MB, C09060MV, C09060SB, C09060SV, C09080MB, C09080MV, C09080SB, C09080SV, C09100MB, C09100MV, C09100SB, C09100SV, C10020MB, C10020MV, C10020SB, C10020SV, C10030MB, C10030MV, C10030SB, C10030SV, C10040MB, C10040MV, C10040SB, C10040SV, C10060MB, C10060MV, C10060SB, C10060SV, C10080MB, C10080MV, C10080SB, C10080SV, C10100MB, C10100MV, C10100SB, C10100SV, C12020MB, C12020MV, C12020SB, C12020SV, C12030MB, C12030MV, C12030SB, C12030SV, C12040MB, C12040MV, C12040SB, C12040SV, C12060MB, C12060MV, C12060SB, C12060SV, C12080MB, C12080MV, C12080SB, C12080SV, C14030MB, C14030MV, C14030SB, C14030SV, C14040MB, C14040MV, C14040SB, C14040SV, C14060MB, C14060MV, C14060SB, C14060SV, C14080MB, C14080MV, C14080SB, C14080SV.

Recalling firm:

Cardinal Health Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84228

Lot/product code:

All Lot Codes. Affected SKUs: N1020SB, N1020SB, N1020SC, N1030SB, N1030SB, N1030SC, N1040SB, N1040SB, N1040SC, N520SB, N520SC,  N530SB, N530SC, N540SB, N540SC, N620SB, N620SC, N630SB, N630SC, N640SB, N640SC, N720SB, N720SC, N730SB, N730SC, N740SB, N740SC,  N820SB, N820SB, N820SC, N830SB, N830SB, N830SC, N840SB, N840SB, N840SC, N920SB, N920SB, N920SC, N930SB, N930SB, N930SC, N940SB, N940SB, N940SC, P05020RXB, P05030RXB, P05040RXB, P0520RXCE, P0530RXCE, P0540RXCE, P06020RXB, P06030RXB, P06040RXB, P0620RXCE, P0630RXCE, P0640RXCE, P07020RXB, P07030RXB, P07040RXB, P0720RXCE, P0730RXCE, P0740RXCE, P08020RXB, P08030RXB, P08040RXB, P0820RXCE, P0830RXCE, P0840RXCE, P09020RXB, P09030RXB, P0920RXCE, P0930RXCE, P0940RXCE, P10020RXB, P1020RXCE, P1030RXCE, P1040RXCE.

Recalling firm:

Cardinal Health Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84228

Lot/product code:

All Lot Codes. Affected SKUs: N1020ABR, N1020BBR, N1020TBR, N1040ABR, N1040BBR, N1040EBR, N1040TBR, N1060ABR, N1060BBR, N1060EBR, N1060TBR, N1080ABR, N1080BBR, N1080EBR, N1080TBR, N6120BV, N620ABR, N620BBR, N620TBR, N640ABR, N640BBR, N640TBR, N660ABR, N660BBR, N660TBR, N680ABR, N680BBR, N680TBR, N7120BV, N720ABR, N720BBR, N720TBR, N740ABR, N740BBR, N740TBR, N760ABR, N760BBR, N760TBR, N780ABR, N780BBR, N780TBR, N8120BV, N820ABR, N820BBR, N820TBR, N840ABR, N840BBR, N840EBR, N840TBR, N860ABR,  N860BBR, N860EBR, N860TBR, N880ABR, N880BBR, N880EBR, N880TBR, N920ABR, N920BBR, N920TBR, N940ABR, N940BBR, N940TBR, N960ABR, N960BBR, N960TBR, N980ABR, N980BBR, N980TBR.

Recalling firm:

Cardinal Health Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84301

Lot/product code:

Lot: 65549

Recalling firm:

Leica Microsystems, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84430

Lot/product code:

All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***

Recalling firm:

Medtronic Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84499

Lot/product code:

The products involved are DeWALT laser distance measurers, model numbers DWO 165, DWO 1 65S, DW0330S and Stanley Fat Max FMHT77506 TLM 165. These products were produced for DeWALT and Stanley by a contract manufacturer..

Recalling firm:

STANLEY BLACK & DECKER INC.

FDA has not published a risk classification for this recall yet.

Recall #:

84430

Lot/product code:

All Serial Numbers ( excluding devices with black retainer rings)

Recalling firm:

Medtronic Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84430

Lot/product code:

All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***

Recalling firm:

Medtronic Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

84364

Lot/product code:

1) REF KB9000-01 Lot Numbers: 9798560, 49798543, 49976101, 49798578, 49976119, 50166762, 50166842, 50353058, 50353066, 50353074, 50353082, 50353091, 50353103, 50471126, 50575494, 50555223  2) REF 11-450A-00 Lot Numbers: 9798480, 50226649, 50226665, 49832318, 49976047, 50034962, 49976063, 49976071, 50167028, 50167052, 50166949, 50343909, 50353023, 50353031, 50353040, 50429112, 50465800, 50465797, 50555258, 50653675    3) REF 1150UTPP Lot Numbers: 49799386, 49843130, 49910865, 49976645, 49976637, 50166447, 50343870, 50352952, 50352961, 50352979, 50352987, 50352995, 50385594

Recalling firm:

DeRoyal Industries Inc

FDA has not published a risk classification for this recall yet.

Recall #:

84430

Lot/product code:

All Serial Numbers ( excluding devices with black retainer rings)

Recalling firm:

Medtronic Inc.