Recalls affecting Puerto Rico

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

Recall #:

D-0625-2026

Lot/product code:

Lot # 4073005, Exp 03/31/2027

Recalling firm:

CareFusion 213, LLC

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

Recall #:

D-0572-2026

Lot/product code:

Lot #: 1716089, expires: JAN 2029.

Recalling firm:

Guardian Drug Co. Inc.

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

Recall #:

D-0568-2026

Lot/product code:

Lot #: 1716089, expires: JAN 2029.

Recalling firm:

Guardian Drug Co. Inc.

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

Recall #:

D-0563-2026

Lot/product code:

Lot #: 1276119, Exp 1/31/2029.

Recalling firm:

Guardian Drug Co. Inc.

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

Recall #:

D-0564-2026

Lot/product code:

Lot #: 1716089, expires: JAN 2029.

Recalling firm:

Guardian Drug Co. Inc.

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

Recall #:

D-0558-2026

Lot/product code:

Lot #: 1096075, 1096076, 1096077, 1096078, Exp 1/31/2029.

Recalling firm:

Guardian Drug Co. Inc.

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

Recall #:

99209

Lot/product code:

UDI-DI 10198459704543 Lot 26DBB599

Recalling firm:

Medline Industries, LP

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

Recall #:

99123

Lot/product code:

3070-27008/Lots: 668261/UDI: 10806378125997; 3070-27009/Lots: 680797/UDI: 10806378126000; 3070-27010/Lots: 667231, 682194/UDI: 10806378126017; 3070-27011/Lots: 680621, 680737/UDI: 10806378126024; 3070-27012/Lots: 667233, 668266, 668704, 682195/UDI: 10806378126031; 3070-27013/Lots:668706, 680400/UDI: 10806378126048; 3070-27014/Lots: 667236, 668705, 680935/UDI: 10806378126055; 3070-27015/Lots: 667237, 680936/UDI: 10806378126062; 3070-27016/Lots: 668269, 682390/UDI: 10806378126079; 3070-27017/Lot: 681575/UDI: 10806378126086; 3070-27018/Lot: 667169, 668260, 682482/UDI: 10806378126093; 3076-30010/Lots: 667202, 668271/UDI: 10806378126109; 3076-30012/Lots: 667242, 668273/UDI: 10806378126116; 3076-30014/Lots: 667205, 668272/UDI: 10806378126123

Recalling firm:

Acumed LLC

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

Recall #:

99207

Lot/product code:

UDI-DI/GTIN: A7630006392701, 00763000521554, 00763000639273, A7630006392301, 00199150035687, A7630007325603, A7630007325601, 00763000639235, A7630007325604, 00763000384289, 00763000521530, A7630007325401, 00763000521547, A7630006392601, A7630006392201, 00763000639228, 00199150035663, 00763000639266, A7630007325404, 00199150035694, 00763000442194, A7630007325403, 00763000521523. Software version 6.62

Recalling firm:

Medtronic MiniMed, Inc.

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

Recall #:

D-0584-2026

Lot/product code:

Lot #: 25282724A, Exp. Date 2027/01

Recalling firm:

Lannett Company Inc.

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

Recall #:

98968

Lot/product code:

Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002

Recalling firm:

Dexcom, Inc.

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

Recall #:

99105

Lot/product code:

Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204

Recalling firm:

Inter-Med Llc

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

Recall #:

99105

Lot/product code:

Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204

Recalling firm:

Inter-Med Llc

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

Recall #:

98968

Lot/product code:

Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002

Recalling firm:

Dexcom, Inc.

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

Recall #:

D-0588-2026

Lot/product code:

Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027

Recalling firm:

Glenmark Pharmaceuticals Inc., USA

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

Recall #:

D-0594-2026

Lot/product code:

Lot: PA00805, expires: 01/31/2029

Recalling firm:

Ajanta Pharma USA Inc

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

Recall #:

99084

Lot/product code:

UDI/DI 00884838000414, Serial Numbers: DE79646555, DE79646616, DE79646645, DE79646647, DE79646651, DE79646697, DE79646702, DE79646746, DE79646754, DE79646757, DE79646758, DE79646762, DE79646765, DE79646775, DE79646776, DE79646783, DE79646857, DE79646891, DE79646924, DE79646750, DE79646751, DE79646756, DE79646804, DE79646592, DE79646877, DE79646644, DE79646706, DE79646723, DE79646653, DE79646766, DE79646786, DE79646824, DE79646827, DE79646848, DE79646956, DE79646709, DE79646892, DE79646724, DE79646729, DE79646732, DE79646733, DE79646927, DE79646675, DE79646820, DE79646821, DE79646837, DE79646866, DE79646869, DE79646871, DE79646875, DE79646882, DE79646683, DE79646676, DE79646640, DE79646849, DE79646952, DE79646699, DE79646694, DE79646648, DE79646701, DE79646900, DE79647027, DE79647039, DE79646654, DE79646800, DE79646604, DE79646660, DE79646829, DE79646747, DE79646606, DE79646826, DE79646784, DE79646794.

Recalling firm:

Philips North America Llc

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

Recall #:

99084

Lot/product code:

UDI/DI 00884838000407, Serial Numbers: DE79569306, DE79569332, DE79569360, DE79569417, DE79569442, DE79569482, DE79569307, DE79569470, DE79569390, DE79569356, DE79569452, DE79569289, DE79569302, DE79569536, DE79569358, DE79569343, DE79569457, DE79569353, DE79569373, DE79569411, DE79569491, DE79569615, DE79569287, DE79569338, DE79569437, DE79569459, DE79569473, DE79569340, DE79569308, DE79569377, DE79569286, DE79569304, DE79569327, DE79569330, DE79569347, DE79569352, DE79569400, DE79569418, DE79569431, DE79569436, DE79569456, DE79569469, DE79569474, DE79569588, DE79569326, DE79569424, DE79569487, DE79569547, DE79569290, DE79569258, DE79569367, DE79569370, DE79569380, DE79569388, DE79569311, DE79569440, DE79569460, DE79569527, DE79569462, DE79569299, DE79569261, DE79569405, DE79569260, DE79569313, DE79569369, DE79569216.

Recalling firm:

Philips North America Llc

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

Recall #:

99199

Lot/product code:

MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001

Recalling firm:

Medtronic Perfusion Systems

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

Recall #:

99199

Lot/product code:

MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220

Recalling firm:

Medtronic Perfusion Systems

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

Recall #:

H-1128-2026

Lot/product code:

Lot codes: 15525AA exp date: 6/2027 00926AA exp date: 1/2028

Recalling firm:

MOGO Moringa LLC

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

Recall #:

99035

Lot/product code:

GTIN: 07630002800839/ Lot # range: 00001 -19732

Recalling firm:

Hamilton Medical AG

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 #:

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 #:

99031

Lot/product code:

GTIN 00763000341367, Lot Numbers: 0012508285, 0012517045, 0012526102, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663878, 0012663879, 0012690218, 0012699635, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824770, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965210, 0012965211, 0012976400, 0012986693, 0013063766, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624, 0013236643, 0013272796, 0013272798. GTIN 00763000544027, Lot Numbers: 0012508285, 0012526103, 0012614786, 0012614787, 0012623740, 0012623741, 0012642959, 0012659419, 0012663879, 0012702022, 0012710787, 0012728367, 0012728369, 0012777713, 0012804152, 0012804579, 0012824771, 0012874526, 0012896853, 0012896884, 0012910323, 0012965211, 0012976400, 0012986693, 0013063767, 0013105039, 0013105040, 0013133457, 0013181623, 0013181624. GTIN 00763000520151, Lot Numbers: 0012575897, 0012642965, 0012728368, 0013272799. GTIN 00763000582951, Lot Numbers: 0012590535, 0012606411, 0012606413, 0012642964, 0012659418, 0012678282, 0012690219, 0012699637, 0012804151, 0012804580, 0012874527, 0012888682, 0012896885, 0012965221, 0012986699, 0013063764, 0013063765, 0013105037, 0013227504. GTIN 00763000918712, Lot Numbers: 0012635392, 0012676200, 0012690207, 0012874528, 0012874529, 0013015539, 0013105038.

Recalling firm:

Medtronic Heart Valves Division