Recalls affecting Puerto Rico

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

Recall #:

98502

Lot/product code:

Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;

Recalling firm:

Magellan Diagnostics, Inc.

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

Recall #:

D-0422-2026

Lot/product code:

Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR1, Exp 12/31/2027; 4500119IR1, Exp 12/31/2027; 4500120IR1, Exp 12/31/2027; 4500121IR1, Exp 12/31/2027; 4500268IR1, Exp 1/31/2028; 4500269IR1, Exp 1/31/2028; 4500272IR1, Exp 1/31/2028; 4500314IR2, EXP 1/31/2028; 4500314RIR, EXP 1/31/2028; 4500315IR1, Exp 2/28/2028; 4500352IR1, Exp 2/28/2028; 4500353IR1, Exp 2/28/2028; 4500354IR1, Exp 2/28/2028; 4500355IR1, Exp 2/28/2028; 4500408IR1, Exp 2/28/2028; 4500409IR1, Exp 3/31/2028; 4500410IR1, Exp 3/31/2028; 4500480IR1, Exp 3/31/2028; 4500481IR1, Exp 3/31/2028; 4500545IR1, Exp 3/31/2028; 4500546IR1, Exp 3/31/2028; 4500588IR1, Exp 4/30/2028; 4500589IR1, Exp 4/30/2028; 4500635IR1, Exp 4/30/2028; 4500636IR1, Exp 4/30/2028; 4500687IR1, Exp 4/30/2028; 4500688IR1, Exp 4/30/2028; 4500758IR1, Exp 4/30/2028; 4500759IR1, Exp 5/31/2028; 4500788IR1, Exp 5/31/2028; 4500789IR1, Exp 5/31/2028; 4500819IR1, Exp 5/31/2028; 4500846IR1, Exp 5/31/2028; 4500849IR1, Exp 6/30/2028; 4500850IR1, Exp 7/31/2028; 4500907IR1, Exp 7/31/2028; 4501108IR1, Exp 7/31/2028; 4501109IR1, Exp 7/31/2028; 4501110IR1, Exp 7/31/2028; 4501111IR1, Exp 7/31/2028; 4501166IR1, Exp 7/31/2028; 4501386IR1, Exp 8/31/2028; 4501387IR1, Exp 8/31/2028;

Recalling firm:

Cipla USA, Inc.

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

Recall #:

98586

Lot/product code:

Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. UDI-DI: 10385083000527. Lot Codes: PH1U02252541, PH1U03282511, PH1U03282522, PH1U03312511, PH1U03312521, PH1U04012511, PH1U04012521, PH1U05052511, PH1U08162531, PH1U08182531, PH1U08182541, PH1U09242511, PH1U09242521, PH1U09242531, PH1U09252521, PH1U09252531, PH1U10152541, PH1U10162531, PH1U10162541, PH1U10172531, PH1U10172541, PH1U10182531, PH1U10182541, PH1U10202511, PH1U10202521, PH1U10202531, PH1U10202541, PH1U10212531, PH1U10212541, PH1U10222531, PH1U10222541, PH1U10232531, PH1U10232541, PH1U10242521, PH1U10242531, PH1U10242541.

Recalling firm:

Insulet Corporation

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

Recall #:

H-0590-2026

Lot/product code:

Lot#: 260230 Expiration date: 1/23/2027

Recalling firm:

Western Mixers Produce & Nuts, Inc.

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

Recall #:

98475

Lot/product code:

Software versions 1.4.3, and 1.4.2

Recalling firm:

Beta Bionics, Inc.

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:

H-0892-2026

Lot/product code:

Lot: Expiration date: single CXW T Jan-27 3pack CXW T Jan-27 10pack PXW Z Mar-26 10pack XXW W Dec-27

Recalling firm:

Sato Pharmaceutical Inc.

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

Recall #:

H-0589-2026

Lot/product code:

Lot#: 260422, 260442, 260543, Expiration date: 2/11/2027, 2/13/2027, 2/23/2027

Recalling firm:

Western Mixers Produce & Nuts, Inc.

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

Recall #:

98561

Lot/product code:

UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)

Recalling firm:

Brahms GmbH

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

Recall #:

98627

Lot/product code:

No UDI. All lots affected.

Recalling firm:

Healthmark Industries Co., Inc.

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

Recall #:

98594

Lot/product code:

Product Code: 87-9136. UDI-DI: 00810022403099. All serial numbers of the CORE Workstation are affected.

Recalling firm:

Linkbio Corp.

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

Recall #:

98772

Lot/product code:

UDI 04056869046877

Recalling firm:

Siemens Medical Solutions USA, Inc

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

Recall #:

98618

Lot/product code:

Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671

Recalling firm:

ARROW INTERNATIONAL, LLC

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

Recall #:

H-0640-2026

Lot/product code:

NFDM Low Heat, NFDM High Heat, and SMP Medium Heat Lot Codes : 26015B; 26016B; 26017B; 26018B; 26019B; 26022B; 26023B; 26024B; 26024BT; 26025B; 26025BT; 26026B; 26027B; 26028B; 26029B; 26030B; 26034B; 26035B; 26040B; 26041B; 26041BT; 26042B; 26042BT; 26043B; 26044B; 26046BT; 26047BT; 26048BT. The products were packaged in 25 kg bags or 1 metric ton totes.

Recalling firm:

Lone Star Dairy Products LLC

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

Recall #:

D-0431-2026

Lot/product code:

Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.

Recalling firm:

Fresenius Kabi USA, LLC

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

Recall #:

D-0436-2026

Lot/product code:

Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.

Recalling firm:

Fresenius Kabi USA, LLC

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

Recall #:

D-0437-2026

Lot/product code:

Batch# 6402165, Exp Date: 05/30/2028.

Recalling firm:

Fresenius Kabi USA, LLC

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

Recall #:

D-0429-2026

Lot/product code:

Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.

Recalling firm:

Fresenius Kabi USA, LLC

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

Recall #:

98659

Lot/product code:

UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209

Recalling firm:

Windstone Medical Packaging, Inc.

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

Recall #:

D-0426-2026

Lot/product code:

Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027.

Recalling firm:

Fresenius Kabi USA, LLC

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

Recall #:

98653

Lot/product code:

US: Basic UDI Number 0763000B000262284, GTIN: 00763000871741; 00763000973391; 00763000973506; 00763000993269; 00199150003709. OUS: 00763000871734; 00763000973384; 00763000973513; 00763000811341; 00763000911515; 00763000963675; 00199150003716. Serial Numbers: 227076469, 2301234000, 2301321000, 2301373000, 2301543000, 2301547000, 2301551000, 2301552000, 2301556000, 2301558000, 2301559000, 2301560000, 2301709000, 0012573781, 0012576276, 0012578858, 0012583026, 0012583027, 0012590913, 0012590914, 0012594540, 0012594541, 0012609253, 0012609255, 0012609258, 0012614806, 0012614807, 0012614808, 0012619893, 0012619896, 0012619898, 0012619899, 0012623987, 0012623988, 0012623991, 0012631219, 0012631220, 0012631221, 0012631222, 0012635279, 0012635281, 0012635282, 0012635283, 0012635284, 0012641293, 0012641294, 0012641295, 0012641297, 0012643392, 0012643393, 0012643396, 0012643399, 0012645205, 0012645206, 0012645208, 0012655005, 0012655006, 0012655008, 0012655009, 0012655010, 0012655011, 0012655012, 0012655013, 0012655014, 0012655015, 0012655016, 0012655017, 0012665669, 0012665670, 0012665671, 0012665673, 0012665674, 0012665675, 0012670372, 0012670375, 0012670377, 0012670380, 0012670381, 0012670383, 0012672152, 0012672156, 0012672157, 0012672158, 0012672159, 0012672160, 0012672161, 0012672162, 0012672163, 0012672164, 0012672166, 0012672167, 0012681148, 0012681149, 0012681151, 0012681152, 0012681153, 0012681154, 0012681155, 0012681157, 0012681159, 0012681160, 0012685946, 0012685947, 0012685948, 0012685950, 0012685951, 0012685952, 0012685953, 0012685954, 0012685955, 0012688084, 0012690714, 0012690716, 0012690717, 0012690719, 0012690731, 0012690732, 0012690733, 0012690735, 0012690736, 0012690737, 0012690738, 0012690739, 0012699686, 0012699687, 0012699688, 0012699689, 0012699691, 0012699693, 0012699694, 0012699695, 0012699696, 0012699697, 0012699698, 0012699699, 0012703730, 0012703731, 0012703732, 0012703733, 0012703734, 0012703735, 0012703736, 0012703737, 0012703740, 0012703741, 0012703743, 0012703744, 0012705502, 0012705503, 0012705504, 0012705505, 0012705506, 0012705507, 0012705508, 0012705509, 0012705510, 0012705512, 0012716663, 0012716664, 0012716665, 0012716666, 0012716667, 0012716668, 0012716669, 0012716670, 0012716671, 0012716672, 0012716673, 0012716674, 0012724581, 0012724583, 0012724605, 0012724606, 0012724607, 0012724608, 0012724609, 0012724610, 0012724612, 0012724613, 0012728680, 0012728681, 0012728682, 0012728684, 0012728686, 0012728688, 0012728689, 0012740819, 0012740820, 0012740821, 0012740823, 0012740824, 0012740825, 0012740855, 0012740856, 0012740857, 0012740858, 0012743381, 0012743382, 0012743384, 0012743385, 0012743386, 0012743387, 0012743388, 0012743389, 0012743390, 0012743393, 0012743495, 0012743496, 0012752332, 0012752333, 0012752334, 0012752335, 0012752336, 0012752337, 0012752338, 0012752340, 0012752341, 0012754564, 0012754565, 0012754566, 0012754567, 0012754568, 0012754569, 0012754570, 0012754571, 0012758280, 0012758281, 0012758282, 0012758285, 0012758286, 0012758287, 0012758288, 0012758289, 0012760403, 0012760404, 0012760405, 0012760406, 0012760407, 0012760408, 0012760409, 0012760411, 0012762277, 0012762278, 0012762279, 0012762280, 0012762281, 0012762282, 0012762283, 0012762284, 0012765019, 0012765020, 0012777959, 0012777961, 0012777962, 0012777964, 0012777965, 0012777985, 0012777986, 0012777987, 0012777989, 0012777991, 0012781703, 0012783280, 0012783281, 0012783282, 0012783283, 0012783284, 0012783285, 0012783286, 0012783288, 0012783293, 0012783298, 0012784425, 0012784426, 0012784427, 0012784428, 0012784429, 0012784430, 0012784431, 0012784432, 0012784433, 0012784434, 0012794827, 0012794828, 0012794829, 0012794831, 0012794832, 0012794833, 0012794835, 0012794836, 0012794837, 0012794839, 0012794840, 0012794849, 0012794850, 0012794851, 0012794854, 0012794855, 0012794856, 0012794857, 0012794858, 0012794860, 0012794861, 0012794863, 0012794864, 0012794865, 0012794866, 0012794867, 0012794868, 0012794869, 0012794870.0012794871, 0012794872, 0012794873, 0012794874, 0012794875, 0012794876, 0012794877, 0012794878, 0012794879, 0012794897, 0012794898, 0012794900, 0012794948, 0012794952, 0012794953, 0012794954, 0012794955, 0012794956, 0012800168, 0012800175, 0012800184, 0012800185, 0012802040, 0012802043, 0012802044, 0012802046, 0012802111, 0012802113, 0012802114, 0012802115, 0012804219, 0012804220, 0012804221, 0012804223, 0012804225, 0012804226, 0012804227, 0012804228, 0012824948, 0012824949, 0012824950, 0012824951, 0012824952, 0012824955, 0012830178, 0012830179, 0012830180, 0012830181, 0012830182, 0012830183, 0012830184, 0012830185, 0012830186, 0012834156, 0012834157, 0012834158, 0012834162, 0012834166, 0012834167, 0012834168, 0012834169, 0012834170, 0012834171, 0012837948, 0012837949, 0012838052, 0012838053, 0012838054, 0012838055, 0012840611, 0012840614, 0012840615, 0012840616, 0012840618, 0012840619, 0012843009, 0012843010, 0012843011, 0012843012, 0012843013, 0012843014, 0012845157, 0012845158, 00128… (truncated, 27239 characters total — see the official FDA record for the full value)

Recalling firm:

Medtronic, Inc.

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

Recall #:

98618

Lot/product code:

Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347

Recalling firm:

ARROW INTERNATIONAL, LLC

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

Recall #:

D-0428-2026

Lot/product code:

Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.

Recalling firm:

Fresenius Kabi USA, LLC

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

Recall #:

98659

Lot/product code:

UDI-DI: B098AMS149940; Lot Numbers: 220039 221423 224226 224793 225009

Recalling firm:

Windstone Medical Packaging, Inc.

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

Recall #:

98659

Lot/product code:

UDI-DI: B098AMS144330; Lot Numbers: 204612 206723 210211 213641 216064 222060 224073 225012 236012 236910

Recalling firm:

Windstone Medical Packaging, Inc.

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

Recall #:

D-0425-2026

Lot/product code:

Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.

Recalling firm:

Fresenius Kabi USA, LLC