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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/virusAnnounced 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.

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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

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UnclassifiedBacteria/virusAnnounced 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

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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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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
Class IIModerate risk
DrugRecalled April 8, 2026

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

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-0699-2026
Lot/product code:
Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27
Recalling firm:
Blaine Labs Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 8, 2026

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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-0697-2026
Lot/product code:
Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
Recalling firm:
Blaine Labs Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

ALL 50 STATES
Full report

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

Recall #:
98603
Lot/product code:
Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371
Recalling firm:
Becton, Dickinson and Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

ALL 50 STATES
Full report

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

Recall #:
98750
Lot/product code:
Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900A, GTIN 00643169890923, Serial Numbers: NPL0004445; 2. Model Number CT900B, GTIN 00643169890947, Serial Numbers: NPL1000042, NPL1000045, NPL1000046, NPL1000048, NPL1000050, NPL1000051, NPL1000053, NPL1000054, NPL1000059, NPL1000060, NPL1000062, NPL1000065, NPL1000069, NPL1000070, NPL1000071, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000077, NPL1000081, NPL1000082, NPL1000083, NPL1000085, NPL1000086, NPL1000087, NPL1000090, NPL1000091, NPL1000093, NPL1000094, NPL1000098, NPL1000117, NPL1000133, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000159, NPL1000160, NPL1000164, NPL1000166, NPL1000167, NPL1000169, NPL1000173, NPL1000174, NPL1000179, NPL1000180, NPL1000183, NPL1000185, NPL1000186, NPL1000187, NPL1000188, NPL1000191, NPL1000192, NPL1000193, NPL1000194, NPL1000195, NPL1000196, NPL1000230, NPL1000235, NPL1000237, NPL1000242, NPL1000244, NPL1000245, NPL1000246, NPL1000248, NPL1000249, NPL1000252, NPL1000254, NPL1000257, NPL1000258, NPL1000281, NPL1000292, NPL1000297, NPL1000301, NPL1000303, NPL1000307, NPL1000321, NPL1000322, NPL1000323, NPL1000325, NPL1000326, NPL1000332, NPL1000334, NPL1000343, NPL1000361, NPL1000362, NPL1000363, NPL1000364, NPL1000365, NPL1000366, NPL1000367, NPL1000369, NPL1000370, NPL1000381, NPL1000483, NPL1000486, NPL1000487, NPL1000501, NPL1000502, NPL1000505, NPL1000506, NPL1000507, NPL1000509, NPL1000510, NPL1000512, NPL1000515, NPL1000516, NPL1000518, NPL1000519, NPL1000528, NPL1000529, NPL1000539, NPL1000540, NPL1000555, NPL1000556, NPL1000558, NPL1000560, NPL1000561, NPL1000562, NPL1000563, NPL1000564, NPL1000571, NPL1000573, NPL1000574, NPL1000575, NPL1000576, NPL1000577, NPL1000578, NPL1000580, NPL1000585, NPL1000592, NPL1000603, NPL1000606, NPL1000612, NPL1000627, NPL1000630, NPL1000631, NPL1000632, NPL1000634, NPL1000637, NPL1000641, NPL1000652, NPL1000653, NPL1001194, NPL1001195, NPL1001201, NPL1001204, NPL1001205, NPL1001206, NPL1001207, NPL1001208, NPL1001210, NPL1001211, NPL1001212, NPL1001216, NPL1001223, NPL1001224, NPL1001225, NPL1001226, NPL1001228, NPL1001229, NPL1001230, NPL1001231, NPL1001235, NPL1001236, NPL1001237, NPL1001238, NPL1001240, NPL1001241, NPL1001243, NPL1001244, NPL1001250, NPL1001251, NPL1001254, NPL1001259, NPL1001264, NPL1001265, NPL1001272, NPL1001273, NPL1001274, NPL1001277, NPL1001282, NPL1001283, NPL1001290, NPL1001291, NPL1001306, NPL1001307, NPL1001313, NPL1001314, NPL1001328, NPL1001330, NPL1001332, NPL1001333, NPL1001334, NPL1001336, NPL1001337, NPL1001339, NPL1001341, NPL1001345, NPL1001349, NPL1001350, NPL1001351, NPL1001353, NPL1001354, NPL1001360, NPL1001361, NPL1001362, NPL1001366, NPL1001367, NPL1001369, NPL1001372, NPL1001375, NPL1001380, NPL1001381, NPL1001385, NPL1001386, NPL1001389, NPL1001398, NPL1001407, NPL1001408, NPL1001410, NPL1001412, NPL1001419, NPL1001421, NPL1001423, NPL1001430, NPL1001431, NPL1001434, NPL1001435, NPL1001436, NPL1001439, NPL1001445, NPL1001449, NPL1001458, NPL1001461, NPL1001464, NPL1001465, NPL1001468, NPL1001482, NPL1001483, NPL1001486, NPL1001499, NPL1001500, NPL1001505, NPL1001507, NPL1001510, NPL1001512, NPL1001513, NPL1001514, NPL1001518, NPL1001520, NPL1001524, NPL1001526, NPL1001531, NPL1001532, NPL1001537, NPL1001539, NPL1001540, NPL1001541, NPL1001542, NPL1001544, NPL1001545, NPL1001546, NPL1001547, NPL1001549, NPL1001550, NPL1001678, NPL1001689, NPL1001694, NPL1001695, NPL1001697, NPL1001699, NPL1001700, NPL1001701, NPL1001702, NPL1001705, NPL1001707, NPL1001708, NPL1001709, NPL1001710, NPL1001711, NPL1001716, NPL1001717, NPL1001723, NPL1001724, NPL1001727, NPL1001728, NPL1001739, NPL1001740, NPL1001741, NPL1001742, NPL1001743, NPL1001744, NPL1001745, NPL1001748, NPL1001749, NPL1001750, NPL1001754, NPL1001755, NPL1001756, NPL1001757, NPL1001759, NPL1001760, NPL1001761, NPL1001763, NPL1001764, NPL1001765, NPL1001766, NPL1001767, NPL1001769, NPL1001770, NPL1001773, NPL1001777, NPL1001784, NPL1001787, NPL1001789, NPL1001792, NPL1001794, NPL1001795, NPL1001797, NPL1001798, NPL1001799, NPL1001800, NPL1001801, NPL1001803, NPL1001804, NPL1001805, NPL1001806, NPL1001811, NPL1001812, NPL1001815, NPL1001816, NPL1001817, NPL1001820, NPL1001823, NPL1001824, NPL1001825, NPL1001829, NPL1001830, NPL1001833, NPL1001841, NPL1001842, NPL1001843, NPL1001844, NPL1001847, NPL1001875, NPL1001876, NPL1001877, NPL1001879, NPL1001880, NPL1001881, NPL1001882, NPL1001884, NPL1001885, NPL1001886, NPL1001887, NPL1001888, NPL1001889, NPL1001891, NPL1001897, NPL1001899, NPL1001900, NPL1001901, NPL1001903, NPL1001904, NPL1001905, NPL1001937, NPL1001940, NPL1001946, NPL1001947, NPL1001948, NPL1001950, NPL1001955, NPL1001957, NPL1001959, NPL1001963, NPL1001966, NPL1001968, NPL1001969, NPL1001970, NPL1001971, NPL1001972, NPL1001973, NPL1001974, NPL1001975, NPL1001976, NPL1001977, NPL1001995, NPL1001996, NPL1002004, NPL1002007, NPL1002010, NPL1002016, NPL1002020, NPL1002021, NPL1002025, NPL1002034, NPL10… (truncated, 122673 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

ALL 50 STATES
Full report

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

Recall #:
98566
Lot/product code:
"Model No.; UDI": [SDA-SYS-3000-2D-HTC;15420045510616], [SDA-SYS-3000-3D;15420045517783], [SDM-SYS-6000-2D;15420045510753], [SDM-SYS-6000-3D;15420045510760], [SDM-00001-2D;15420045510623], [SDM-00001-3D;15420045510630], [SDM-00001-M2D;15420045510647], [SDM-00001-M3D;15420045510654], [SDM-05000-2A2;15420045510661], [SDM-05000-2A3;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

ALL 50 STATES
Full report

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

Recall #:
98603
Lot/product code:
Model/UDI-DI/Lot(Expiration): 131F7P/00690103000412/65902900(8/1/2026), 65902901(8/3/2026), 65910728(8/2/2026), 65910729(7/29/2026),65910730(7/27/2026), 65910731(7/25/2026), 65910732(7/26/2026), 65910735(7/30/2026), 65910736(8/24/2026), 65910737(7/31/2026), 65916927(8/3/2026), 65916928(8/6/2026), 65916929(8/7/2026), 65916930(8/8/2026), 65916931(8/9/2026), 65916932(8/22/2026), 65916933(8/23/2026), 65944791(8/20/2026),65944792(8/21/2026), 65955857(9/9/2026), 65955858(9/17/2026), 65955859(9/26/2026), 65955860(9/27/2026), 65973739(9/5/2026), 65973740(9/6/2026), 65973741(9/7/2026), 65973742(9/10/2026), 65988571(9/28/2026), 65997478(9/16/2026), 65997479(9/17/2026), 65997481(9/19/2026), 65997482(9/20/2026), 66010504(9/10/2026), 66010505(9/11/2026), 66010506(9/12/2026), 66010507(9/13/2026), 66010508(9/14/2026), 66023074(9/30/2026), 66033088(10/5/2026), 66048930(10/9/2026), 66057629(10/6/2026), 66057630(10/8/2026), 66057944(10/15/2026), 66057945(10/17/2026), 66061552(10/24/2026), 66074999(10/4/2026), 66075318(11/19/2026), 66104892(10/21/2026), 66104893(10/22/2026), 66104894(10/23/2026), 66104895(11/13/2026), 66108277(11/15/2026), 66118638(11/22/2026), 66120310(10/29/2026), 66120312(10/30/2026), 66120313(10/31/2026), 66127027(11/15/2026), 66127028(11/20/2026), 66132570(11/21/2026), 66132571(11/25/2026), 66132572(11/27/2026), 66140447(11/2/2026), 66140448(11/5/2026), 66140449(11/6/2026), 66140450(11/7/2026), 66142269(11/28/2026), 66142274(11/29/2026), 66151008(12/20/2026), 66160820(11/30/2026), 66160821(12/3/2026), 66160822(12/4/2026), 66160823(12/5/2026), 66174935(12/6/2026), 66186389(12/9/2026), 66186390(12/10/2026), 66186391(12/11/2026), 66186393(12/19/2026), 66214346(12/12/2026), 66214347(12/17/2026), 66214348(12/13/2026), 66214349(12/16/2026), 66225263(1/24/2027), 66230833(1/27/2027), 66230834(1/28/2027), 66231174(1/29/2027), 66236300(2/3/2027), 66243301(1/30/2027), 66243302(2/1/2027), 66254697(2/4/2027), 66254698(2/10/2027), 66273573(2/11/2027), 66273574(2/12/2027), 66283862(2/8/2027), 66296222(3/5/2027), 66315689(3/6/2027), 66351811(3/8/2027), 66351812(3/11/2027), 66351813(3/12/2027), 66378395(3/13/2027), 66378396(3/18/2027), 66384489(3/18/2027), 66414674(3/22/2027), 66438179(4/3/2027), 66438197(4/12/2027), 66438198(5/24/2027), 66438199(5/27/2027), 66438200(4/10/2027), 66439368(3/26/2027), 66439369(3/31/2027), 66439370(4/2/2027), 66439371(4/7/2027), 66439372(4/9/2027), 66488597(5/28/2027), 66521743(4/16/2027), 66529338(4/15/2027), 66529339(4/21/2027), 66529340(4/22/2027), 66529341(4/23/2027), 66529345(5/23/2027), 66544240(4/24/2027), 66594945(5/14/2027), 66597237(4/29/2027), 66597238(4/30/2027), 66597239(5/10/2027), 66601166(5/2/2027), 66601167(5/8/2027), 66601168(5/12/2027), 66601169(5/13/2027), 66601170(5/14/2027), 66601171(5/29/2027), 66642726(5/9/2027), 66692566(6/6/2027), 66704724(6/4/2027), 66710839(6/2/2027), 66710840(6/3/2027), 66739812(6/13/2027), 66739813(6/18/2027), 66739814(6/17/2027), 66739910(6/24/2027), 66739911(7/17/2027), 66739912(7/9/2027), 66739913(6/16/2027), 66739916(6/23/2027), 66740114(7/17/2027), 66758828(7/10/2027), 66767282(6/28/2027), 66769651(7/18/2027), 66782067(7/21/2027), 66826029(7/23/2027), 66826030(7/24/2027), 66832079(7/25/2027), 66844048(7/31/2027), 66873884(8/2/2027), 66873885(8/5/2027), 66873886(8/18/2027), 66895223(8/20/2027), 66938771(8/22/2027), 66938772(8/26/2027), 66938773(8/27/2027), 66964710(9/1/2027), 66964711(9/4/2027), 66982688(9/26/2027), 67025469(10/20/2027), 67047800(10/17/2027), 67047801(10/21/2027), 67068446(10/28/2027), 67092101(10/28/2027), 67098252(10/30/2027), 67098253(11/3/2027), 67199591(11/12/2027), 67199595(11/13/2027), 67199596(11/11/2027), 67199617(11/21/2027), 67199618(11/22/2027), 67217934(1/7/2028), 67217935(12/4/2027), 67266297(1/12/2028), 67275624(12/20/2027), 67275626(12/3/2027), 67322713(1/13/2028), 67322714(1/16/2028), 67357488(1/29/2028), 67395549(2/5/2028), 67395555(1/28/2028), 66739917(6/12/2027); 131F7/00690103000405/ 65902900(8/1/2026), 65902901(8/3/2026), 65910728(8/2/2026), 65910729(7/29/2026), 65910730(7/27/2026), 65910731(7/25/2026), 65910732(7/26/2026), 65910735(7/30/2026), 65910736(8/24/2026), 65910737(7/31/2026), 65916927(8/3/2026), 65916928(8/6/2026), 65916929(8/7/2026), 65916930(8/8/2026), 65916931(8/9/2026), 65916932(8/22/2026), 65916933(8/23/2026), 65944791(8/20/2026), 65944792(8/21/2026), 65955857(9/9/2026), 65955858(9/17/2026), 65955859(9/26/2026), 65955860(9/27/2026), 65973739(9/5/2026), 65973740(9/6/2026), 65973741(9/7/2026), 65973742(9/10/2026), 65988571(9/28/2026), 65997478(9/16/2026), 65997479(9/17/2026), 65997481(9/19/2026), 65997482(9/20/2026), 66010504(9/10/2026), 66010505(9/11/2026), 66010506(9/12/2026) ,66010507(9/13/2026) ,66010508(9/14/2026) ,66023074(9/30/2026) ,66033088(10/5/2026) ,66048930(10/9/2026), 66057629(10/6/2026), 66057630(10/8/2026), 66057944(10/15/2026), 66057945(10/17/2026), 66061552(10/24/2026), 66074999(10/4/2026), 66075318(11/19/2026), 66104892(10/21/2026), 66104893(10/22/2026), 66104894(10/23/… (truncated, 14046 characters total — see the official FDA record for the full value)
Recalling firm:
Becton, Dickinson and Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

Swan-Ganz Pacing Catheter, Models: D200F7;

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

ALL 50 STATES
Full report

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

Recall #:
98603
Lot/product code:
Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027)
Recalling firm:
Becton, Dickinson and Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

ALL 50 STATES
Full report

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

Recall #:
98566
Lot/product code:
"[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 8, 2026

vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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-0696-2026
Lot/product code:
Lot BL3462, Exp. 2/7/2027
Recalling firm:
Blaine Labs Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 7, 2026

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

ALL 50 STATES
Full report

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

Recall #:
98657
Lot/product code:
Catalog Nunber: 260684; UDI-DI: 30382902606841; Lot Numbers: 5303157, 5329857, 5329860.
Recalling firm:
Becton Dickinson & Co.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 7, 2026

BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

ALL 50 STATES
Full report

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

Recall #:
98657
Lot/product code:
Catalog Number: 260685; UDI-DI: 30382902606858; Lot Number: 5329863.
Recalling firm:
Becton Dickinson & Co.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled April 7, 2026

Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950

Failed PH Specifications

ALL 50 STATES
Full report

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

Recall #:
D-0509-2026
Lot/product code:
Lots: A5014, A5018, A5019
Recalling firm:
Water-Jel Technologies, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 7, 2026

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.

This recall is being conducted due to not meeting quality requirements assay results in a limited number of bottles that were stored on side.

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-0526-2026
Lot/product code:
Lot # AC2040A, Exp Date: 04/2026
Recalling firm:
Hikma Pharmaceuticals USA INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 6, 2026

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Not guaranteed to be germ-free: Potential leaks from perforations in bags.

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-0513-2026
Lot/product code:
Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 6, 2026

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Failed Impurities/Degradation Specifications: not meeting quality requirements for specific impurity Tretinoin

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-0521-2026
Lot/product code:
Lots#: 100067507, 100067508, Exp 07/31/2026
Recalling firm:
Teva Pharmaceuticals USA, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 6, 2026

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Not guaranteed to be germ-free: Potential leaks from perforations in bags.

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-0512-2026
Lot/product code:
Lot #: 25CU02007, 25CU02008, 25CU02009
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2026

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Product has the potential for false positive results

ALL 50 STATES
Full report

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

Recall #:
98709
Lot/product code:
UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
Recalling firm:
Quidel Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2026

INZONE DETACHMENT SYSTEM, REF: M00345100950

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

ALL 50 STATES
Full report

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

Recall #:
98630
Lot/product code:
UDI-DI: 04546540697950. Lots: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, WMP134234, WMP134235, WMP134255, WMP134256, WMP134380, WMP134381, WMP134432, WMP134433, WMP134518, WMP134519, WMP134609, WMP134610, WMP134794, WMP134795, WMP134939, WMP134940, WMP135187, WMP135243, WMP135302, WMP135314, WMP135354, WMP135355, WMP135387, WMP135417, WMP135473, WMP135475, WMP135491, WMP135492, WMP135623, WMP135720, WMP135727, WMP135807, WMP135865, WMP135897, WMP136084, WMP136107, WMP136190, WMP136200, WMP136611, WMP136642, WMP136736, WMP136748, WMP136852, WMP136894, WMP136985
Recalling firm:
Stryker Neurovascular
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2026

The intended use is to be paired with a weapon for aiming purposes.

Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.

ALL 50 STATES
Full report

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

Recall #:
99059
Lot/product code:
None provided.
Recalling firm:
Wilcox Industries Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2026

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events

ALL 50 STATES
Full report

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

Recall #:
98755
Lot/product code:
Lots: 0000616462, 0000619851, 0000552987, 0000551725. UDI: (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115930(11)240325(17)270228(10)0000551725, (01)00842429115930(11)240325(17)270228(10)0000551725, (01)00842429115930(11)240610(17)270531(10)0000616462, (01)00842429115930(11)240610(17)270531(10)0000616462, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851.
Recalling firm:
MICROVENTION INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled April 4, 2026

Dakota Honey Company Spreadable Spun Honey, Original. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60010-57969 5. 2. Net Wt 12 oz (340g) UPC 8 60010-57961 9.

Foreign object (stainless steel dust/flakes or shreds of plastic)

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 #:
H-0768-2026
Lot/product code:
Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026
Recalling firm:
Dakota Honey Company
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled April 4, 2026

Dakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41981 4. 2. Net Wt 12 oz (340g) UPC 8 60010-57964 0.

Foreign object (stainless steel dust/flakes or shreds of plastic)

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 #:
H-0770-2026
Lot/product code:
Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026
Recalling firm:
Dakota Honey Company
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled April 4, 2026

Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41982 1. 2. Net Wt 12 oz (340g) UPC 8 60010-57965 7.

Foreign object (stainless steel dust/flakes or shreds of plastic)

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 #:
H-0771-2026
Lot/product code:
Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026
Recalling firm:
Dakota Honey Company
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled April 4, 2026

Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41980 7. 2. Net Wt 12 oz (340g) UPC 8 60010-57963 3.

Foreign object (stainless steel dust/flakes or shreds of plastic)

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 #:
H-0769-2026
Lot/product code:
Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026
Recalling firm:
Dakota Honey Company
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled April 4, 2026

Dakota Honey Company the Honey Flight. 4 Flavors of Spreadable Spun Honey Original - Salted Caramel - Cinnamon - Jalapeno. UPC 8 60010-57968 8. 4 - 4 oz (340g) jars. Net Wt 16 oz (454g). Produced in Winner, SD.

Foreign object (stainless steel dust/flakes or shreds of plastic)

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 #:
H-0772-2026
Lot/product code:
Honey does not have any code on container. 4 oz spun honey Flights purchased from December 19, 2025 to April 3, 2026
Recalling firm:
Dakota Honey Company
View official FDA record (opens in a new tab)