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Recalls affecting Hawaii

Data last updated: September 9, 2026 at 1:18 PM UTC

16,268 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Allura Xper FD20/10; System Code: 722029;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
System Code: 722029; UDI: 00884838059078; System Serial Number: 57, 7, 88, 56, 126, 94, 30, 31, 21, 97, 91, 110, 100, 63, 60, 55, 62, 129, 71, 36, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 127, 14, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 50, 51, 124, 87, 20, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); UDI-DI: 25051684007891(Box), 15051684007894(Pouch); Lot No.: A2825033, A2825034, A2825132, A2825133, A3725048, A3725049;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 3, 2026

Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4

Not guaranteed to be germ-free

ALL 50 STATES
Full report

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

Recall #:
D-0414-2026
Lot/product code:
Lot: a) RL24D01, Exp.: 04/30/26; RL24F01, RL24F02, Exp.:06/30/26; b) RL24F01, RL24F02, Exp.:06/30/26; c) RL24F01, Exp.:06/30/26; d) RL24F02, Exp.:06/30/26; e) RL24F01, RL24F02, Exp.:06/30/26; f) RL24F01, RL24F02, Exp.:06/30/26; g) RL24F01, RL24F02, Exp.:06/30/26; h) RL24F01, Exp.:06/30/26; i) RL24F01, Exp.:06/30/26; j) RL24F02, Exp.:06/30/26; k)
Recalling firm:
K.C. Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); UDI-DI: 25051684005712(Box), 15051684005715(Pouch); Lot No.: A2725033, A2725034, A3525048, A3525049;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); UDI-DI: 25051684005996(Box), 15051684005999(Pouch); Lot No.: A2825044;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); UDI-DI: 25051684007785(Box), 15051684007788(Pouch); Lot No.: A2525060, A2525061, A3625006, A3625007;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Allura Xper FD20/20; System Code: 722038;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
System Code: 722038; UDI: 00884838054226; System Serial Number: 71, 115, 42, 108, 173, 119, 60, 37, 38, 99, 130, 48, 157, 41, 141, 137, 49, 63, 35, 167, 55, 70, 39, 62, 46, 118, 67, 78, 120, 7, 106, 102, 169, 11, 89, 117, 40, 105, 113, 110, 5, 134, 88, 64, 112, 143, 94, 109, 73, 166, 147, 31, 3, 127, 92, 135, 32, 69, 121, 123, 98, 129, 79, 14, 148, 153, 122, 164, 111, 160, 171, 172, 159, 155, 144, 163, 152, 168, 161, 158, 156, 138, 162, 132, 95, 116, 45, 9, 150, 146, 90, 27, 91, 154, 104, 124, 30, 136, 72, 93, 66, 140, 75, 50, 68, 58, 54, 47, 36, 170, 29;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Allura Xper FD20/15; System Code: 722058;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
System Code: 722058; UDI: 00884838059115; System Serial Number: 100, 239, 305, 259, 203, 373, 111, 38, 23, 290, 124, 274, 340, 366, 162, 186, 4, 196, 156, 285, 277, 65, 168, 56, 178, 138, 212, 249, 257, 337, 265, 109, 134, 71, 238, 190, 219, 197, 325, 24, 123, 319, 378, 61, 205, 149, 264, 167, 365, 199, 278, 215, 288, 254, 94, 304, 279, 171, 82, 85, 202, 99, 182, 22, 200, 129, 59, 172, 110, 399, 72, 332, 92, 142, 67, 106, 335, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 101, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 408, 360, 370, 400, 387, 356, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 331, 379, 418, 421, 369, 420, 397, 357, 393, 388, 108, 211, 125, 126, 301, 30, 354, 355, 159, 139, 128, 81, 58, 96, 343, 177, 115, 18, 19, 311, 386, 291, 327, 220, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 3, 2026

Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05

Not guaranteed to be germ-free

ALL 50 STATES
Full report

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

Recall #:
D-0411-2026
Lot/product code:
Lot: a) LT24E01, LT24E02, LT24E03, Exp.: 05/31/26; LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; LT24M01, LT24M02, Exp.: 10/31/26; b) LT24E03, Exp.: 05/31/26; LT24F01, Exp.:06/30/26; LT24G01, Exp.:07/31/26; LT24M02, Exp.: 10/31/26; c) LT24F01, Exp.: 06/30/26; d) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; e) LT24F01, Exp.: 06/30/26; f) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; g) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; h) LT24F01, Exp.: 06/30/26; i) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; j) LT24F01, Exp.: 06/30/26; k) LT24G01, Exp.: 07/31/26; L) LT24F01, Exp.: 06/30/26; m)
Recalling firm:
K.C. Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); UDI-DI: 25051684007778(Box), 15051684007771(Pouch); Lot No.: A2425078, A3325036, A3525030, A3525031, A3725102;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); UDI-DI: 25051684007938(Box), 15051684007931(Pouch); Lot No.: A2825145;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 3, 2026

Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3

Not guaranteed to be germ-free

ALL 50 STATES
Full report

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

Recall #:
D-0413-2026
Lot/product code:
Lot: a) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; b) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; c) RG24G02, Exp.: 07/31/26; d) RG24E01, Exp.: 05/31/26; RG24G01, RG24G02; Exp.: 07/31/26; e) RG24E01, Exp.: 05/31/26; RG24G01, Exp.: 07/31/26; f) RG24E01, Exp.: 05/31/26; RG24G02; Exp.: 07/31/26; g) RG24E01, Exp.: 05/31/26; h) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; i) RG24E01, Exp.: 05/31/26; j) RG24E01, Exp.: 05/31/26; k) RG24E01, Exp.: 05/31/26; L) RG24E01, Exp.: 05/31/26; m) RG24E01, Exp.: 05/31/26; n) RG24G01, Exp.: 07/31/26; o) RG24G01, Exp.: 07/31/26; p) RG24G02, Exp.: 07/31/26; q)RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; r) RG24G02, Exp.: 07/31/26
Recalling firm:
K.C. Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); UDI-DI: 25051684008102(Box), 15051684008105(Pouch); Lot No.: A2725049;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722068; UDI: 00884838085367; System Serial Number: 547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42, 153, 324, 323, 320, 85, 89, 109, 407, 239, 505, 271, 443, 104, 370, 322, 136, 373, 442, 524, 308, 354, 75, 279, 400, 196, 510, 110, 446, 78, 330, 73, 288, 285, 295, 406, 528, 329, 184, 350, 462, 304, 457, 470, 472, 319, 520, 490, 243, 103, 479, 261, 262, 150, 277, 172, 117, 130, 356, 143, 146, 84, 251, 469, 431, 361, 76, 374, 270, 114, 511, 477, 232, 137, 282, 487, 413, 337, 101, 213, 82, 265, 275, 485, 459, 276, 62, 506, 608, 473, 417, 302, 314, 88, 126, 211, 468, 422, 454, 410, 283, 231, 548, 466, 495, 207, 167, 445, 537, 438, 173, 233, 289, 536, 192, 204, 77, 166, 313, 236, 133, 481, 280, 307, 577, 210, 258, 328, 325, 199, 480, 53, 72, 364, 491, 423, 509, 246, 614, 142, 376, 539, 257, 140, 369, 195, 500, 508, 97, 87, 303, 48, 44, 301, 550, 460, 118, 293, 551, 478, 522, 568, 448, 242, 238, 68, 160, 83, 544, 230, 434, 435, 360, 93, 36, 372, 179, 306, 182, 583, 327, 244, 382, 428, 432, 215, 447, 338, 399, 339, 316, 555, 552, 570, 347, 148, 134, 38, 560, 158, 535, 318, 518, 250, 336, 185, 206, 50, 489, 521, 37, 79, 529, 111, 254, 427, 394, 71, 47, 534, 292, 497, 591, 35, 227, 359, 527, 387, 168, 128, 129, 396, 515, 486, 543, 69, 453, 174, 483, 484, 334, 425, 181, 408, 415, 141, 365, 471, 540, 584, 553, 602, 240, 617, 604, 593, 589, 526, 559, 612, 450, 556, 557, 574, 603, 601, 609, 616, 597, 605, 575, 516, 624, 599, 563, 590, 198, 600, 228, 380, 420, 397, 212, 475, 180, 268, 269, 414, 74, 562, 115, 349, 291, 519, 234, 219, 532, 533, 60, 398, 618, 549, 46, 96, 416, 249, 531, 426, 162, 290, 346, 49, 326, 286, 125, 102, 113, 124, 138, 362, 127, 145, 299, 317, 571, 187, 183, 45, 331, 106, 465, 281, 112, 501, 393, 116, 273, 188, 264, 139, 503, 122, 439, 135, 248, 404, 390, 263, 90, 300, 224, 67, 61, 157, 154, 100, 217, 253, 391, 144, 379, 202, 105, 226, 315, 464, 197, 63, 252, 175, 274, 163, 186, 260, 502, 152, 498, 156, 621, 296, 208, 430, 161, 436, 409, 155, 298, 191, 278, 368, 94, 66, 108, 200, 201, 98, 189, 311, 367, 297, 132, 507, 451; (2) System Code: 722226; UDI: 00884838099272; System Serial Number: 120, 122, 123, 124, 125, 126, 127, 153, 67, 209, 271, 675, 112, 1052, 1091, 113, 121, 139, 158, 1078, 1145, 239, 105, 678, 114, 362, 758, 403, 702, 108, 545, 197, 380, 281, 688, 592, 593, 495, 319, 687, 921, 182, 183, 325, 690, 100, 272, 680, 724, 350, 891, 280, 270, 254, 107, 144, 761, 681, 691, 779, 294, 845, 559, 116, 343, 98, 301, 117, 876, 1021, 244, 332, 781, 782, 534, 341, 374, 78, 11, 441, 129, 180, 918, 442, 220, 555, 189, 190, 871, 446, 842, 255, 848, 208, 554, 955, 360, 337, 159, 400, 757, 326, 323, 175, 427, 464, 468, 778, 683, 143, 262, 482, 971, 391, 392, 173, 793, 147, 204, 467, 1017, 260, 381, 912, 410, 508, 419, 313, 472, 894, 318, 473, 383, 689, 973, 463, 823, 181, 205, 361, 59, 756, 379, 1008, 266, 1002, 398, 75, 786, 19, 1125, 213, 214, 215, 1007, 814, 969, 970, 469, 219, 462, 296, 149, 704, 573, 458, 987, 141, 711, 693, 510, 882, 226, 509, 584, 21, 1050, 647, 225, 201, 202, 303, 666, 184, 243, 178, 179, 250, 1139, 674, 1062, 575, 1121, 368, 950, 861, 176, 712, 829, 413, 997, 249, 589, 1046, 708, 738, 1083, 717, 697, 1126, 665, 416, 386, 764, 977, 595, 859, 1113, 721, 1043, 797, 957, 1006, 498, 60, 232, 423, 682, 789, 698, 331, 1097, 1094, 378, 808, 1107, 393, 949, 718, 663, 195, 411, 1092, 412, 715, 1143, 775, 1073, 982, 282, 785, 617, 958, 221, 222, 604, 430, 1027, 1067, 415, 810, 1114, 61, 1147, 314, 822, 561, 1026, 1102, 762, 306, 359, 978, 1060, 972, 83, 199, 1013, 920, 1136, 898, 835, 836, 795, 671, 799, 800, 899, 905, 838, 944, 1123, 335, 363, 1039, 731, 399, 869, 725, 701, 626, 967, 623, 744, 501, 953, 1018, 513, 533, 677, 449, 119, 367, 927, 480, 732, 974, 344, 824, 984, 487, 919, 605, 230, 523, 686, 327, 1138, 424, 684, 477, 1049, 298, 809, 10, 227, 520, 521, 522, 993, 874, 259, 140, 628, 530, 506, 909, 142, 733, 263, 490, 494, 633, 634, 396, 547.631, 514, 642, 505, 321, 754, 17, 422, 1057, 420, 247, 99, 36, 432, 539, 88, 245, 911, 132, 133, 667, 5, 1103, 188, 586, 14, 622, 228, 4, 1069, 45, 316, 164, 485, 448, 507, 97, 351, 497, 685, 771, 790, 1076, 543, 66, 542, 550, 551, 484, 504, 714, 1054, 366, 18, 1048, 893, 1132, 217, 752, 1088, 47, 544, 148, 408, 906, 289, 548, 238, 299, 283, 284, 401, 404, 827, 833, 84, 692, 895, 118, 924, 224, 233, 1087, 579, 515, 455, 946, 599, 726, 676, 395, 670, 1, 261, 444, 826, 93, 956, 1077, 900, 901, 320, 355, 710, 435, 1072, 820, 749, 235, 846, 727, 621, 1129, 1041, 777, 1053, 274, 486, 1014, 1015, 503, 1071, 431, 481, 460, 765, 194, 696, 1099, 25, 451, 438, 275, 552, 352, 87, 630, 1047, 941, 345, 349, 429, 854, 1009, 888, 369, 557, 585, 596, 342, 457, 645, 739, 736, 1127, 963, 527, 251, 1115, 1000, 965, 553, 1042, 699, 1064, 574, 741, 748, 1137, 887, 632, 1118, 737, 1131, 1148, 1111, 907, 662, 825, 1075, 877, 1134, 1023, 648, 831, 1135, 751, 1061, 1036, 1104, 830, 1152, 860, 798, 603, 577, 938… (truncated, 7713 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 3, 2026

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.

Failed Impurities/Degradation Specifications: An not meeting quality requirements result observed during 9th-month long term stability testing

ALL 50 STATES
Full report

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

Recall #:
D-0384-2026
Lot/product code:
Lot #: 1TM0524003A, Exp. Date 09/2026.
Recalling firm:
Rising Pharma Holding, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); UDI-DI: 25051684010112(Box), 15051684010115(Pouch); Lot No.: A2825021, A2825129, A3325027, A3425027, A3525014, A3825095;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
(1) System Code: 722079; UDI: 00884838085268; System Serial Number: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534, 535, 536, 818, 412, 617, 246, 488, 53, 57, 905, 55, 691, 992, 809, 848, 1033, 836, 891, 1155, 466, 1157, 1395, 703559, 263, 420, 703391, 673, 297, 298, 299, 564, 838, 1032, 1117, 987, 1310, 1211, 1213, 47, 1365, 1408, 881, 774, 856, 922, 58, 471, 1012, 755, 633, 703540, 296, 703558, 574, 703336, 842, 884, 991, 753, 703493, 1086, 790, 840, 407, 408, 481, 703350, 877, 703395, 703323, 703775, 590, 709, 710, 711, 713, 716, 1216, 483, 1098, 1392, 241, 703408, 1108, 1363, 1355, 1414, 703387, 703404, 863, 350, 528, 703465, 1380, 908, 1238, 1378, 262, 598, 858, 859, 275, 703861, 520, 335, 1018, 593, 911, 480, 1410, 703329, 213, 325, 496, 887, 903, 703413, 1432, 594, 1309, 1312, 999, 1424, 465, 674, 1084, 353, 499, 1230, 813, 703508, 33, 1346, 1189, 1401, 361, 267, 403, 439, 526, 1021, 736, 1370, 608, 68, 703324, 611, 413, 414, 415, 453, 703306, 895, 703615, 587, 1297, 1399, 428, 883, 1267, 422, 758, 1040, 634, 573, 714, 274, 525, 843, 885, 1276, 1102, 703478, 1142, 792, 919, 703528, 754, 599, 1171, 1096, 1097, 766, 817, 78, 703419, 1322, 878, 1170, 1107, 703435, 703310, 944, 654, 703521, 273, 703305, 715, 703495, 1285, 854, 19, 904, 1005, 804, 703497, 730, 1400, 954, 375, 957, 697, 703332, 658, 423, 1022, 896, 897, 1411, 1430, 621, 703426, 628, 795, 272, 1007, 940, 250, 46, 1289, 605, 65, 360, 468, 472, 469, 828, 737, 925, 32, 857, 703416, 703327, 34, 1222, 1268, 1063, 703335, 769, 938, 655, 229, 738, 1204, 1311, 572, 776, 538, 797, 989, 946, 888, 393, 394, 1062, 52, 703396, 703420, 281, 939, 703407, 1219, 955, 402, 1042, 867, 868, 909, 931, 703425, 374, 459, 1282, 841, 703532, 1436, 703344, 1358, 1359, 1360, 1391, 703389, 50, 1006, 1352, 580, 581, 703309, 703383, 703510, 974, 1245, 396, 860, 326, 741, 584, 721, 216, 899, 703, 927, 928, 923, 981, 865, 1163, 416, 268, 689, 717, 497, 900, 1369, 424, 1258, 1323, 959, 447, 448, 1385, 1386, 852, 1252, 802, 915, 703379, 703402, 751, 704281, 436, 703311, 1402, 910, 866, 703418, 1242, 354, 708, 251, 703501, 1064, 1156, 1049, 342, 343, 344, 345, 1271, 631, 18, 479, 1103, 1361, 577, 1041, 1423, 29, 1043, 1270, 1250, 805, 930, 1200, 228, 30, 366, 543, 588, 355, 356, 357, 358, 359, 1090, 445, 703314, 945, 1226, 1232, 1236, 1237, 853, 801, 1187, 222, 247, 474, 62, 70, 703450, 537, 48, 351, 777, 41, 898, 703317, 653, 684, 703334, 912, 746, 703368, 703562, 54, 1231, 731, 540, 998, 618, 1179, 703360, 1283, 668, 1431, 607, 706, 847, 879, 703308, 837, 1251, 703575, 387, 417, 1316, 45, 1393, 1290, 334, 320, 429, 212, 290, 703409, 239, 669, 703390, 629, 1078, 800, 56, 703584, 470, 595, 64, 671, 793, 1059, 1381, 1382, 747, 585, 1246, 663, 1212, 703333, 1274, 255, 455, 637, 862, 1379, 1235, 810, 1164, 227, 437, 438, 703345, 990, 314, 613, 427, 60, 1100, 703486, 602, 318, 937, 703515, 703455, 703456, 703457, 942, 948, 1201, 1247, 702, 333, 703388, 644, 845, 846, 1415, 1000, 814, 284, 352, 703356, 703380, 703381, 265, 679, 328, 329, 330, 331, 332, 1017, 1039, 1374, 750, 1016, 783, 703550, 703685, 703551, 703813, 704301, 780, 703719, 217, 476, 815, 816, 214, 703565, 1280, 704304, 561, 59, 703338, 719, 894, 744, 745, 704059, 729, 943, 302, 31, 337, 703552, 703613, 704240, 704242, 703662, 1340, 549, 703838, 1037, 703823, 703670, 1026, 377, 379, 380, 1405, 258, 259, 260, 395, 433, 451, 662, 703355, 703449, 703654, 703699, 703870, 703612, 704299, 704300, 703899, 1306, 970, 1248, 822, 449, 1047, 1019, 1241, 557, 1143, 752, 704129, 558, 947, 1190, 1196, 1172, 1319, 703712, 1397, 1398, 289, 704295, 994, 703326, 703655, 703702, 703939, 531, 703802, 703897, 704203, 704266, 1389, 703953, 703986, 703600, 570, 703769, 458, 962, 703374, 703710, 704026, 703592, 215, 703384, 703392, 545, 703753, 703967, 704112, 984, 703992, 703807, 1036, 1351, 703463, 703818, 871, 703529, 1073, 704154, 778, 548, 798, 704037, 933, 316, 703669, 704290, 234, 1429, 313, 49, 704209, 722, 703619, 704142, 378, 418, 1053, 600, 825, 452, 969, 1020, 1265, 763, 703545, 703358, 1095, 703487, 704092, 461, 1239, 703867, 786, 578, 703572, 559, 560, 982, 703462, 464, 703583, 1106, 1044, 703855, 704127, 1205, 1206, 1214, 450, 703348, 252, 703872, 430, 997, 271, 312, 1338, 855, 1169, 1030, 1120, 339, 1121, 934, 1168, 1150, 699, 704199, 703489, 703959, 913, 563, 304, 1191, 567, 566, 916, 388, 707, 1195, 1193, 301, 554, 555, 704282, 704284, 1083, 703966, 303, 305, 704101, 1194, 785, 703961, 1337, 993, 688, 347, 772, 74, 632, 383, 735, 39, 1074, 230, 1182, 1341, 293, 936, 703944, 704258, 295, 675, 949, 411, 701, 287, 286, 232, 760, 421, 726, 1109, 1144, 434, 591, 61, 961, 1072, 1185, 703477, 257, 661, 704146, 703982, 1440, 1441, 1442, 389, 703438, 703783, 704211, 703812, 1122, 725, 703423, 341, 367, 37, 1317, 1192, 1264, 575, 1202, 36, 309, 67, 703824, 1278, 703313, 703544, 703393, 703428, 703713, 703815, 1372, 703330, 1347, 958, 703472, 951, 1009, 482, 1254, 300, 620, 986, 70… (truncated, 30280 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

ALL 50 STATES
Full report

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

Recall #:
98463
Lot/product code:
SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); UDI-DI: 25051684009727(Box), 15051684009720(Pouch); Lot No.: A2825022, A3025035, A3025037;
Recalling firm:
Angiodynamics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Allura Xper FD10C; System Code: 722001;

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

ALL 50 STATES
Full report

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

Recall #:
98434
Lot/product code:
System Code: 722001; UDI: N/A; System Serial Number: 19, 249, 21, 18661014, 77, 82, 195, 216, 337, 37, 258, 283, 15, 256, 305;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2026

Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

ALL 50 STATES
Full report

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

Recall #:
98488
Lot/product code:
All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104
Recalling firm:
Wilson-Cook Medical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

ALL 50 STATES
Full report

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

Recall #:
98537
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

ALL 50 STATES
Full report

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

Recall #:
98537
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

ALL 50 STATES
Full report

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

Recall #:
98540
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

ALL 50 STATES
Full report

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

Recall #:
98540
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

ALL 50 STATES
Full report

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

Recall #:
98540
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)