Recalls affecting Maryland

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

Recall #:

D-0598-2026

Lot/product code:

Lot #: AD93852, Exp Date: 06/2027.

Recalling firm:

SUN PHARMACEUTICAL INDUSTRIES INC

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

Recall #:

99002

Lot/product code:

Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.

Recalling firm:

Abiomed, Inc.

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

Recall #:

99143

Lot/product code:

Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796, VSWVH1006 / 00733132638796; Lot Serial No. 30970948, 30970949, 30970950, 30970951, 30970952, 30970953, 30970954, 30970955, 30970956, 30970957, 30970958, 30970959, 30970960.

Recalling firm:

W L Gore & Associates, Inc.

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

Recall #:

99002

Lot/product code:

Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.

Recalling firm:

Abiomed, Inc.

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

Recall #:

99002

Lot/product code:

1. Impella Set Product Code: 1000413; GTIN: 00813502013566; Serial numbers: 649727, 649728, 649729, 649730, 649731, 654349, 654348, 654342, 654341, 654340, 654339, 654338, 654336, 654335, 654334, 654333, 653010, 653009, 653008, 653007, 653006, 653005, 653004, 653003, 653002, 653001, 655735, 655733, 654357, 654356, 654382, 654383, 654381, 654380, 654378, 654367, 654366, 654364, 654365, 654362, 654363, 654361, 654360, 654359, 654358, 654379, 655734, 654386, 654355, 654385, 654384, 654353, 654352, 654351, 654350, 654387, 657649, 657648, 657646, 657647, 657645, 657644, 655742, 655739, 655741, 655740, 655738, 655737, 655736, 656743, 656738, 653050, 653049, 653048, 653047, 653045, 653044, 653043, 653042, 653041. Introducer Product Code: 2000684; Batch Numbers: 2026724558, 2027818724. 2. Product Code: 1000834. GTIN: 00813502013948. Serial numbers: 653474, 653471, 653485, 653470, 653469, 653468, 653467, 653465, 653466, 653463, 653464, 653482, 653483, 653484, 653481, 653490, 653462, 653478, 653479, 653489, 653488, 653487, 653486, 653476, 653477, 656002, 656001, 656000, 655998, 655997, 655993, 655996, 655995, 655994, 656737, 656736, 656735, 656734, 656733, 656730, 656731, 656729, 656728, 656346, 656343, 656342, 656341, 656340, 656338, 659804, 659795, 656347, 650264, 659801, 659802, 659800, 659799, 659798, 656363, 656367, 656362, 656361, 656360, 656359, 656358, 659794, 659793, 659791, 659792, 659790, 659789, 659788, 659786, 659787, 659785, 661408, 661407, 661405, 661404, 661392, 661391, 661389, 661403, 661402, 661401, 661400, 662657, 662654. Introducer Product Code: 2000785; Batch Numbers: 2026787668, 2027818660. Distributed in Japan.

Recalling firm:

Abiomed, Inc.

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:

H-0942-2026

Lot/product code:

1. Lot: 2507199 Exp. 09/2027 Lot: 2512-304 Exp. 02/2028 Lot: 2793 Exp. 02/2028 Lot: 2748 Exp. 07/2027 ASIN: B0DBRDPBDT, SKU: AB8047, UPC: 095234280472, FNSKU: X004C9XHAL 2. Lot: 2507199 Exp. 09/2027 Lot: 2748 Exp. 07/2027 UPC: 095234698734; SKU: AB9873

Recalling firm:

Total Nutrition Inc

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

Recall #:

99162

Lot/product code:

1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290

Recalling firm:

Medline Industries, LP

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

Recall #:

99162

Lot/product code:

1) ECVC5995, UDI-DI: 10653160338970(each), 00653160338973(case), Lot Number: 2026011990; 2) ECVC2625, UDI-DI: 10653160334255(each), 00653160334258(case), Lot Number: 2025121990; 3) STCVC26US, UDI-DI: 10653160343424(each), 00653160343427(case), Lot Number: 2026010290; 4) ECVC3720, UDI-DI: 10653160341499(each), 00653160341492(case), Lot Number: 2025123090; 5) 3K16H1838, UDI-DI: 10653160341260(each), 00653160341263(case), Lot Number: 2025120590; 6) ECVC5610, UDI-DI: 10653160335047(each), 00653160335040(case), Lot Number: 2025122290; 7) ECVC3810, UDI-DI: 10653160336013(each), 00653160336016(case), Lot Number: 2025102390; 8) ECVC2555, UDI-DI: 10653160336570(each), 00653160336573(case), Lot Number: 2025121190; 9) ECVC2750, UDI-DI: 10653160334217(each), 00653160334210(case), Lot Number: 2025102490; 10) ECVC5200, UDI-DI: 10653160336150(each), 00653160336153(case), Lot Number: 2025101490; 11) ECVC7290, UDI-DI: 10653160344933(each), 00653160344936(case), Lot Number: 2025101490; 12) ECVC3720, UDI-DI: 10653160341499(each), 00653160341492(case), Lot Number: 2025101690; 13) ECVC8215, UDI-DI: 10653160358992(each), 00653160358995(case), Lot Number: 2025101790; 14) ECVC2080, UDI-DI: 10653160334408(each), 00653160334401(case), Lot Number: 2025101690; 15) ECVC8165, UDI-DI: 10653160358749(each), 00653160358742(case), Lot Number: 2025101390; 16) ECVC6505, UDI-DI: 10653160336327(each), 00653160336320(case), Lot Number: 2025101490; 17) STCVC02, UDI-DI: 10653160336822(each), 00653160336825(case), Lot Number: 2025101690; 18) ECVC1377, UDI-DI: 10653160332152(each), 00653160332155(case), Lot Number: 2025101690; 19) CMPI851LBA, UDI-DI: 10653160347453(each), 00653160347456(case), Lot Number: 2025090290; 20) STCVC49US, UDI-DI: 10653160347972(each), 00653160347975(case), Lot Number: 2025092390; 21) ECVC8090, UDI-DI: 10653160357667(each), 00653160357660(case), Lot Number: 2025091990; 22) ECVC2885, UDI-DI: 10653160335405(each), 00653160335408(case), Lot Number: 2025092490; 23) ECVC1377, UDI-DI: 10653160332152(each), 00653160332155(case), Lot Number: 2025092290; 24) ECVC5995, UDI-DI: 10653160338970(each), 00653160338973(case), Lot Number: 2025100790; 25) ECVC6845, UDI-DI: 10653160339366(each), 00653160339369(case), Lot Number: 2025091590; 26) ECVC5540A, UDI-DI: 10653160335009(each), 00653160335002(case), Lot Number: 2025092990; 27) 3K16H1838, UDI-DI: 10653160341260(each), 00653160341263(case), Lot Number: 2025092490; 28) ECVC1120, UDI-DI: 10653160334644(each), 00653160334647(case), Lot Number: 2025091990; 29) ECVC2625, UDI-DI: 10653160334255(each), 00653160334258(case), Lot Number: 2025091990; 30) ECVC5200, UDI-DI: 10653160336150(each), 00653160336153(case), Lot Number: 2025090390; 31) ECVC8075, UDI-DI: 10653160357124(each), 00653160357127(case), Lot Number: 2025091090; 32) ECVC2745, UDI-DI: 10653160334224(each), 00653160334227(case), Lot Number: 2025091190; 33) ECVC7945, UDI-DI: 10653160353966(each), 00653160353969(case), Lot Number: 2025091190; 34) ECVC2750, UDI-DI: 10653160334217(each), 00653160334210(case), Lot Number: 2025091090

Recalling firm:

Medline Industries, LP

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

Recall #:

98855

Lot/product code:

Catalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602

Recalling firm:

BD SWITZERLAND SARL

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

Recall #:

99162

Lot/product code:

1) ART890B, UDI-DI: 10653160360834(each), 00653160360837(case), Lot Number: 2025102390; 2) IVS3350, UDI-DI: 10653160313045(each), 00653160313048(case), Lot Number: 2025102490

Recalling firm:

Medline Industries, LP

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

Recall #:

98898

Lot/product code:

Model Number: PAPA317AA; Amazon FNSKU: X0040USQ0N; Lot Numbers: PS2509A01, PS2511A01, PS2512A01; Date Codes: 2509, 2511, 2512. The recalled product is limited to PAPA317AA replacement brush head packs bearing the above lot numbers/date codes. Products with other lot numbers/date codes are not included in this recall.

Recalling firm:

Papablic Inc

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

Recall #:

99096

Lot/product code:

5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 Lot Number: REKY0255

Recalling firm:

Bard Access Systems, Inc.

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

Recall #:

99162

Lot/product code:

1) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025120590; 2) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025101490; 3) ART155A, UDI-DI: 10653160316459(each), 00653160316452(case), Lot Number: 2025100890; 4) ART1010B, UDI-DI: 10653160353577(each), 00653160353570(case), Lot Number: 2025091590

Recalling firm:

Medline Industries, LP

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

Recall #:

99162

Lot/product code:

1) DYNDH1068, UDI-DI: 10889942172122(each), 40889942172123(case), Lot Number: 2025101090; 2) PHS234706I, UDI-DI: 10198459330278(each), 40198459330279(case), Lot Number: 25JLB029

Recalling firm:

Medline Industries, LP

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

Recall #:

99067

Lot/product code:

UPN: M00558460; GTIN: 8714729339397; Lot No. 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675; Exp. October 27, 2028 January 31, 2029.

Recalling firm:

Boston Scientific Corporation

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

Recall #:

99067

Lot/product code:

UPN: M00558470; GTIN: 8714729339403; Lot No. 38099718, 38165001, 38165002, 38196568, 38196569, 38196570, 38204511, 38204512, 38204513, 38285933, 38397792, 38398767, 38398768, 38507308, 38552115, 38596881, 38596882, 38612829, 38612830, 38680058, 38683384, 38683385, 38689434, 38690171, 38707829, 38707830, 38710480, 38769697, 38800182, 38800183, 38871161, 38871162, 38871163, 38937571 ; Exp. November 2, 2028 February 23, 2029 .

Recalling firm:

Boston Scientific Corporation

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

Recall #:

99162

Lot/product code:

1) DYNJ0621189X, UDI-DI: 10195327638566(each), 40195327638567(case), Lot Number: 25ILA890; 2) PAIN1470A, UDI-DI: 10193489957365(each), 40193489957366(case), Lot Number: 25JLA514; 3) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25JDB583; 4) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDA180; 5) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDB274

Recalling firm:

Medline Industries, LP

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

Recall #:

D-0604-2026

Lot/product code:

BNZ-001921, Exp 04/15/2029

Recalling firm:

Keystone Industries

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

Recall #:

99162

Lot/product code:

1) PAIN0072L, UDI-DI: 10198459544163(each), 40198459544164(case), Lot Number: 25JDB100; 2) PAIN1317, UDI-DI: 10888277797109(each), 40888277797100(case), Lot Number: 25JLA788; 3) PAIN1579A, UDI-DI: 10193489422443(each), 40193489422444(case), Lot Number: 25JLA779; 4) PAIN1885A, UDI-DI: 10195327486310(each), 40195327486311(case), Lot Number: 25JLA861; 5) PAIN1967A, UDI-DI: 10198459241215(each), 40198459241216(case), Lot Number: 25JLA659; 6) PAIN2269, UDI-DI: 10198459342004(each), 40198459342005(case), Lot Number: 25JLA781; 7) PAIN2278, UDI-DI: 10198459376177(each), 40198459376178(case), Lot Number: 25JLA886; 8) PAIN2305, UDI-DI: 10198459478819(each), 40198459478810(case), Lot Number: 25JLA601; 9) PAIN2334, UDI-DI: 10198459540639(each), 40198459540630(case), Lot Number: 25JLA942; 10) SAMPA0147, UDI-DI: 10198459552809(each), 40198459552800(case), Lot Number: 25JLA928;

Recalling firm:

Medline Industries, LP

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

Recall #:

99162

Lot/product code:

1) DYNJRA1590, UDI-DI: 10193489284829(each), 40193489284820(case), Lot Number: 25JLA522

Recalling firm:

Medline Industries, LP

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

Recall #:

99096

Lot/product code:

7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017410352 Lot Number: REKY1686

Recalling firm:

Bard Access Systems, Inc.

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

Recall #:

99067

Lot/product code:

UPN: M00558450; GTIN: 8714729339380; Lot No. 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759; Exp. October 27, 2028 February 24, 2029.

Recalling firm:

Boston Scientific Corporation

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

Recall #:

99162

Lot/product code:

1) I550BF6C, UDI-DI: 10653160339748(each), 00653160339741(case), Lot Number: 2025102290; 2) I505BF9C, UDI-DI: 10653160339687(each), 00653160339680(case), Lot Number: 2025093090

Recalling firm:

Medline Industries, LP

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

Recall #:

99027

Lot/product code:

Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785. 26153EAU/1 seals with expiration date: January 23, 2023.

Recalling firm:

Karl Storz Endoscopy

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

Recall #:

99096

Lot/product code:

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 Lot Numbers: REKP2822 REKW2840 REKX3882 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 Lot Number: REKW2434 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 Lot Number: REKW0907 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 Lot Numbers: REKW2479 REKX3439 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 Lot Numbers: REKP0895 REKX0665 REKX2216 REKY1281

Recalling firm:

Bard Access Systems, Inc.