Recalls affecting Puerto Rico

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 #:

99188

Lot/product code:

LS-749: UDI-DI: M711BTA2020, M711LS7490, Serial Numbers: 002, 003, 007, 012, 014

Recalling firm:

Innovasis, Inc

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 #:

99143

Lot/product code:

Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065.

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.

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

Recall #:

D-0599-2026

Lot/product code:

Lot #: AE11393, Exp Date: 10/2027.

Recalling firm:

SUN PHARMACEUTICAL INDUSTRIES 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 #:

99002

Lot/product code:

Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.

Recalling firm:

Abiomed, 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 #:

99128

Lot/product code:

Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B

Recalling firm:

Instrumentation Laboratory

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 #:

99096

Lot/product code:

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386

Recalling firm:

Bard Access Systems, Inc.

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

Recall #:

99162

Lot/product code:

1) DYNDH1215, UDI-DI: 10889942550876(each), 40889942550877(case), Lot Number: 2025092390

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 #:

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 #:

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 #:

99096

Lot/product code:

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Lot Number: REKV1588 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKX0938 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKY1965

Recalling firm:

Bard Access Systems, Inc.

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

Recall #:

99189

Lot/product code:

UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.

Recalling firm:

Windstone Medical Packaging, 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 #:

99189

Lot/product code:

UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.

Recalling firm:

Windstone Medical Packaging, Inc.

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

Recall #:

99096

Lot/product code:

CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 Lot Number: REKN2105 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 Lot Numbers: REKW2429 REKX1484 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 Lot Number: REKW2494 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 Lot Numbers: REKP0118 REKX2225 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 Lot Number: REKX3430 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 Lot Numbers: REKQ0118 REKW1477 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 Lot Number: REKY0144 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 Lot Numbers: REKW0447 REKW0953 REKX2214 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 Lot Number: REKX3445 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 Lot Number: REKW2430 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 Lot Numbers: REKV3192 REKX3437 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 Lot Number: REKW2448 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 Lot Number: REKW0959

Recalling firm:

Bard Access Systems, Inc.

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) 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 #:

99096

Lot/product code:

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 Lot Number: REKY2412 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 Lot Number: REKY1364 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 Lot Number: RELN0881 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 Lot Number: REKY1381 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 Lot Number: REJZ0927

Recalling firm:

Bard Access Systems, Inc.