Recalls affecting Hawaii

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

Recall #:

98028

Lot/product code:

CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected.

Recalling firm:

Medtronic Neuromodulation

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

Recall #:

D-0221-2026

Lot/product code:

Lot#: C274-000047958; Exp. December 19, 2025

Recalling firm:

Fagron Compounding Services

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

Recall #:

97986

Lot/product code:

Lot Code: UDI:00724995176587, 00724995176594, 00724995176570 Serial number of distributed units: 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, 3624525002

Recalling firm:

Steris Corporation

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

Recall #:

97986

Lot/product code:

Lot Code: UDI: 00724995176662, 00724995176679, 00724995176655 Serial numbers of distributed units: 3619725008, 3619725011, 3619725013, 3621625010, 3621625011, 3621625013, 3621625014, 3621625015, 3621925001, 3621925002, 3621925005, 3621925010, 3622425005, 3622725005, 3622725011, 3622725012, 3623125006, 3623425016, 3623825008, 3624025002, 3624025008, 3624525007

Recalling firm:

Steris Corporation

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

Recall #:

98032

Lot/product code:

UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040

Recalling firm:

Vortex Surgical Inc.

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

Recall #:

D-0222-2026

Lot/product code:

Lot# 17240988; Exp. 05/31/2026

Recalling firm:

Glenmark Pharmaceuticals Inc., USA

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

Recall #:

97969

Lot/product code:

Audio Driver Version: 6.0.9484.1. UDI-DI: 06936415972417. HP Pro Mini 400 G9 Desktop PC. Realtek HD Audio Driver Released by HP. 1. WS host package (mini PC). Part Number 115-050935-00. Quantity 902 2. Exch, Benevision Mini PC Workstation. Part Number E115-050935-00. Quantity 4

Recalling firm:

Mindray DS USA, Inc. dba Mindray North America

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

Recall #:

98101

Lot/product code:

N/A

Recalling firm:

AGFA Healthcare Corp.

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

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: 1530101; UDI-DI: TBD; (2) Model/Catalog Number: 1530102; UDI-DI: TBD;

Recalling firm:

ETAC A/S

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

Recall #:

98068

Lot/product code:

UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01

Recalling firm:

Sheathing Technologies Inc

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

Recall #:

98073

Lot/product code:

UDI/DI 03760124132076, All monitors

Recalling firm:

Sophysa

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

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: M14000; UDI-DI: 05707995032270; Serial Numbers: 616606, 616604, 591003, 591002, 590906, 590901, 590904, 590903, 590902, 591001, 604101, 604005, 591703, 591007, 591006, 591005, 591004, 615105, 615104, 615103, 615102, 615101, 604004, 604003, 604002, 604001, 614202, 614201, 591702, 591701, 616603, 615106, 590905; (2) Model/Catalog Number: M1401; UDI-DI: 05707995032270; Serial Numbers: 593302, 593301, 593303, 612507, 612506, 612508, 612505, 612503, 620702, 612504, 612502, 612501, 593304, 593305, 620703, 620701; (3) Model/Catalog Number: M1402; UDI-DI: 05707995032270; Serial Numbers: 612601; (4) Model/Catalog Number: M14050; UDI-DI: 05707995032270; Serial Numbers: 590801, 596701, 585701, 584501, 591801, 604405, 604406, 604402, 604404, 604403, 604401, 604303, 604302, 604301; (5) Model/Catalog Number: M14150; UDI-DI: 05707995032270; Serial Numbers: 585811, 585810, 585809, 585808, 585806, 585805, 585804, 585803, 585801, 596604, 596603, 596602, 596601, 596611, 596610, 596609, 596608, 596607, 596606, 596605, 585807, 585802; (6) Model/Catalog Number: M1402-01; UDI-DI: 05707995032270; Serial Numbers: 612701, 612703, 612702; (7) Model/Catalog Number: M14050-00; UDI-DI: 05707995032270; Serial Numbers: 584307; (8) Model/Catalog Number: M14001; UDI-DI: 05707995032270; Serial Numbers: 603501, 599801, 599802, 604202, 604201;

Recalling firm:

ETAC A/S

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

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: 1430116; UDI-DI: TBD; (2) Model/Catalog Number: 1430117; UDI-DI: TBD; (3) Model/Catalog Number: 1430115; UDI-DI: TBD;

Recalling firm:

ETAC A/S

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

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: M1501; UDI-DI: TBD; Serial Numbers: 601005, 601002, 611506, 621101, 621106, 621104, 621105, 621102, 611505, 611504, 611503, 611502, 611501, 601008, 611507, 601007, 601006, 601001, 621103, 601003, 601004; (2) Model/Catalog Number: M1502; UDI-DI: TBD; Serial Numbers: 611409, 611408, 611407, 611406, 611405, 611404, 611403, 611402, 611401, 611412, 611411, 611410; (3) Model/Catalog Number: M1504; UDI-DI: TBD; Serial Numbers: 600902, 600901, 611303, 611302, 611301; (4) Model/Catalog Number: M15050; UDI-DI: TBD; Serial Numbers: 586003, 586001, 585905, 585903, 585902, 585901, 598605, 586101, 585904, 603602, 591401, 586002, 586006, 586005, 586004, 598608, 598607, 585906, 591601, 598606, 598604, 598602, 598601, 596501, 603601, 598609, 598603; (5) Model/Catalog Number: M15151; UDI-DI: TBD; Serial Numbers: 599703, 599702, 599701; (6) Model/Catalog Number: M15001; UDI-DI: TBD; Serial Numbers: 584401; (7) Model/Catalog Number: M15002; UDI-DI: TBD; Serial Numbers: 591501, 591502;

Recalling firm:

ETAC A/S

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

Recall #:

D-0239-2026

Lot/product code:

Lot: J1325J, I1725P, EXP Date: 4/30/2027.

Recalling firm:

Preferred Pharmaceuticals, Inc.

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

Recall #:

98064

Lot/product code:

REF 1012-9620-222: GTIN 00195278626301; REF 1012-9620-000: GTIN 00840682103985; REF 1012-9620-200: GTIN 00195278439536; REF 1012-9620-202: GTIN 00195278626158; REF 1012-9620-212: GTIN 00195278626561; REF 1012-9650-222: GTIN 00195278626592; REF 1012-9650-000: GTIN 00840682103947; REF 1012-9650-200: GTIN 00195278439529; REF 1012-9650-202: GTIN 00195278626585; REF 1012-9650-212: GTIN 00195278625687; REF 1012-9655-202: GTIN 00195278625953; REF 1012-9620-002: GTIN 00840682124546; REF 1012-9620-012: GTIN 00195278569677; REF 1012-9650-002: GTIN 00840682124560; REF 1012-9650-012: GTIN 00195278569684; REF 1012-9655-000: GTIN 00840682103954; REF 1012-9655-002: GTIN 00840682124539; REF 1012-9655-200: GTIN 00195278439543.

Recalling firm:

GE Medical Systems China Co., Ltd.

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

Recall #:

98064

Lot/product code:

REF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463.

Recalling firm:

GE Medical Systems China Co., Ltd.

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

Recall #:

98064

Lot/product code:

FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025

Recalling firm:

GE Medical Systems China Co., Ltd.

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

Recall #:

98359

Lot/product code:

Model/Catalog Number: SPL-G; UDI: 00821925044203; Serial Numbers: All;

Recalling firm:

Olympus Corporation of the Americas

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

Recall #:

D-0224-2026

Lot/product code:

Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027

Recalling firm:

Cipla USA, Inc.

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

Recall #:

D-0226-2026

Lot/product code:

Lot 5PB0183, exp 1/31/2027

Recalling firm:

Cipla USA, Inc.

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

Recall #:

D-0225-2026

Lot/product code:

Lot 5PB0164, exp 1/31/2027

Recalling firm:

Cipla USA, Inc.

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

Recall #:

98359

Lot/product code:

Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;

Recalling firm:

Olympus Corporation of the Americas

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

Recall #:

98359

Lot/product code:

Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All;

Recalling firm:

Olympus Corporation of the Americas

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

Recall #:

97904

Lot/product code:

Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596

Recalling firm:

Medtronic MiniMed, Inc.