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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)
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)
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)
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
Class IIModerate risk
DrugRecalled April 1, 2026

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

CGMP deviations.

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-0503-2026
Lot/product code:
120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026
Recalling firm:
Wells Pharma of Houston LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 1, 2026

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Respiratory/sore throat panel test may result in false negative results and control failures.

ALL 50 STATES
Full report

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

Recall #:
98719
Lot/product code:
Lot Number: 2215125/UDI: 00815381020390
Recalling firm:
BioFire Diagnostics, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

Failed Stability Specifications

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Full report

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

Recall #:
D-0487-2026
Lot/product code:
Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027
Recalling firm:
Island Kinetics, Inc. d.b.a. CoValence Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 31, 2026

Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

ALL 50 STATES
Full report

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

Recall #:
98748
Lot/product code:
1. System Code Description: Azurion 3 M12. Model Number [UDI]: 722221 [(01)00884838099203(21)181, (01)00884838099203(21)178, (01)00884838099203(21)93]; 722229 [(01)00884838116726(21)22, (01)00884838116726(21)9, (01)00884838116726(21)16, (01)00884838116726(21)15, (01)00884838116726(21)5, (01)00884838116726(21)3, (01)00884838116726(21)4, (01)00884838116726(21)6, (01)00884838116726(21)2, (01)00884838116726(21)8]. 2. System Code Description: Azurion 3 M15. Model Number [UDI]: 722222 [(01)00884838099210(21)358, (01)00884838099210(21)328, (01)00884838099210(21)389, (01)00884838099210(21)378, (01)00884838099210(21)243, (01)00884838099210(21)392, (01)00884838099210(21)396, (01)00884838099210(21)13, (01)00884838099210(21)379, (01)00884838099210(21)385, (01)00884838099210(21)376, (01)00884838099210(21)366, (01)00884838099210(21)365, (01)00884838099210(21)398, (01)00884838099210(21)274]; 722230 [(01)00884838116733(21)40, (01)00884838116733(21)2, (01)00884838116733(21)41, (01)00884838116733(21)15, (01)00884838116733(21)28, (01)00884838116733(21)38, (01)00884838116733(21)9, (01)00884838116733(21)27, (01)00884838116733(21)13]. 3. System Code Description: Azurion 5. Model Number [UDI]: 722281 [(01)00884838110564(21)401, (01)00884838110564(21)427, (01)00884838110564(21)382, (01)00884838110564(21)425]. 4. System Code Description: Azurion 5 M12. Model Number [UDI]: 722227 [(01)00884838099227(21)265, (01)00884838099227(21)360, (01)00884838099227(21)320, (01)00884838099227(21)338, (01)00884838099227(21)324, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)339, (01)00884838099227(21)321, (01)00884838099227(21)247, (01)00884838099227(21)298, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)336, (01)00884838099227(21)318, (01)00884838099227(21)353, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)345, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)355, (01)00884838099227(21)315, (01)00884838099227(21)280, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)362, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)269, (01)00884838099227(21)294, (01)00884838099227(21)342, (01)00884838099227(21)330, (01)00884838099227(21)340, (01)00884838099227(21)284, (01)00884838099227(21)333, (01)00884838099227(21)253, (01)00884838099227(21)301, (01)00884838099227(21)332, (01)00884838099227(21)334, (01)00884838099227(21)297, (01)00884838099227(21)350, (01)00884838099227(21)307, (01)00884838099227(21)311, (01)00884838099227(21)319, (01)00884838099227(21)286, (01)00884838099227(21)329, (01)00884838099227(21)208, (01)00884838099227(21)178]; 722231 [(01)00884838116740(21)52, (01)00884838116740(21)49, (01)00884838116740(21)50, (01)00884838116740(21)41, (01)00884838116740(21)21, (01)00884838116740(21)53, (01)00884838116740(21)47, (01)00884838116740(21)3, (01)00884838116740(21)25, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)7, (01)00884838116740(21)8, (01)00884838116740(21)4, (01)00884838116740(21)5, (01)00884838116740(21)12, (01)00884838116740(21)60, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)19, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)11, (01)00884838116740(21)35, (01)00884838116740(21)62, (01)00884838116740(21)54, (01)00884838116740(21)33, (01)00884838116740(21)1, (01)00884838116740(21)2, (01)00884838116740(21)32]. 5. System Code Description: Azurion 5 M20. Model Number [UDI]: 722228 [(01)00884838099234(21)481, (01)00884838099234(21)537, (01)00884838099234(21)615, (01)00884838099234(21)538, (01)00884838099234(21)533, (01)00884838099234(21)522, (01)00884838099234(21)600, (01)00884838099234(21)642, (01)00884838099234(21)573, (01)00884838099234(21)659, (01)00884838099234(21)567, (01)00884838099234(21)645, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)569, (01)00884838099234(21)616, (01)00884838099234(21)568, (01)00884838099234(21)629, (01)00884838099234(21)566, (01)00884838099234(21)571, (01)00884838099234(21)647, (01)00884838099234(21)562, (01)00884838099234(21)640, (01)00884838099234(21)676, (01)00884838099234(21)677, (01)00884838099234(21)602, (01)00884838099234(21)461, (01)00884838099234(21)613, (01)00884838099234(21)393, (01)00884838099234(21)660, (01)00884838099234(21)673, (01)00884838099234(21)580, (01)00884838099234(21)668, (01)00884838099234(21)623, (01)00884838099234(21)486, (01)00884838099234(21)487, (01)00884838099234(21)396, (01)00884838099234(21)172, (01)00884838099234(21)575, (01)00884838099234(21)398, (01)00884838099234(21)392, (01)008… (truncated, 47171 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 31, 2026

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

ALL 50 STATES
Full report

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

Recall #:
98674
Lot/product code:
REF/UDI-DI/Lots: 20325-201/04065655000603/W4466253, W4466254, W4466256, W4466257, W4466258, WO471080, WO471081, WO471083, WO471084, WO473975, WO473976, WO477586, WO477587, WO477588, WO477589, WO477590; 20325-203/04065655001211/WO473986
Recalling firm:
Erbe Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 31, 2026

ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

ALL 50 STATES
Full report

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

Recall #:
98674
Lot/product code:
UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014
Recalling firm:
Erbe Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 31, 2026

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

ALL 50 STATES
Full report

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

Recall #:
98674
Lot/product code:
REF/UDI-DI/Lots: 20325-239/04065655000375/W4464506, W4464507, W4464512, W4464514, W4464515, W4464516, W4464517, W4465114, W4465115, W4465116, W4465702, W4465709, W4465991, W4466004, W4466266, W4466267, W4466268, W4466269, W4466271, W4466272, W4466273, W4466275, W4466278, W4466279, W4466813, W4466814, W4466815, W4466816, W4467057, W4467058, W4467059, W4467680, W4467681, W4468147, W4468148, W4468273, W4468274, W4468275, WO468776, WO468777, WO468778, WO468779, WO468780, WO469443, WO469444, WO469448, WO469449, WO469450, WO469451, WO469452, WO469933, WO469934, WO469947, WO469948, WO469949, WO469950, WO469951, WO469952, WO470768, WO470774, WO470775, WO470776, WO470777, WO470778, WO470896, WO470897, WO470913, WO470914, WO470915, WO470922, WO471236, WO471237, WO471238, WO471239, WO471240, WO471241, WO471242, WO473987, WO473988, WO473989, WO473991, WO475246, WO475247, WO475248, WO475249; 20325-240/04065655000405/W4466020, W4466021, WO468768, WO468769, WO468770, WO468771, WO469445, WO469446, WO469447, WO469936, WO469937, WO471244, WO471246, WO473170, WO473171, WO473172, WO473173, WO473174, WO473982, WO473983, WO473984, WO473985, WO474409, WO474410, WO474411, WO474412, WO474413, WO474414, WO475243; 20325-206/04065655000436/W4467039, W4467049, W4467678, W4467679, WO468582, WO470769, WO470770, WO470771, WO470772, WO470773, WO471076, WO471077, WO471078, WO471079, WO471390, WO478365, WO478366, WO478367; 20325-207/04065655000689/W4469939, W4469940, W4469941; 20325-248/04065655001006/W4467050, W4467051, W4467055, W4467056, W4467682, WO470898, WO470899, WO470900, WO470901, WO470902, WO470903, WO471252, WO471253, WO471254, WO471255, WO471256; 20325-208/04065655001099/W4467040, W4468271, WO468760
Recalling firm:
Erbe Medical, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled March 31, 2026

Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1

Weaker than it should be drug

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-0488-2026
Lot/product code:
Lot 23G3161005, Exp 9/21/2027
Recalling firm:
Avantor Performance Materials LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 30, 2026

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

ALL 50 STATES
Full report

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

Recall #:
98679
Lot/product code:
LUX-Dx II Plus UDI-DI: 00802526620706 (US), 00802526623707 (EU/AU); SERVER SW LATITUDE DRAGON EU UDI-DI: 00802526613821; SERVER SW LATITUDE DRAGON AU UDI-DI: 00802526613814; Serial Number: 100085 100676 100909 100944 101811 102341 102405 102864 102956 102978 103018 105283 105697 106372 106429 106690 107386 107460 108132 108429 108433 108641 108697 108805 108861 108901 109663 109699 109836 110700 110737 110858 111048 111119 111269 111290 111362 111780 111987 112265 112549 113400 113495 113720 114072 114393 115310 115411 115835 115862 115890 115981 116066 116090 116197 117180 117533 117560 117820 117924 117960 119462 120931 121080 121203 121267 121483 122855 123305 123412 124378 124458 124557 124791 124987 125008 126249 127182 127441 127758 127821 128106 128506 129528 129763 129782 130474 131469 132487 132549 133195 133786 133989 134600 135362 136038 136746 136884 137047 137134 137319 137449 138039 138059 138334 138759 139080 139165 140319 141181 142273 143441 143887 144590 144777 145284 145336 145684 146709 147185 147618 148972 149028 153330 153628 155199 155735 155898 156145 156895 157872 158926 159162 160236 160471 160615 161307 161762 162801 162821 163556 163802 167866 169673 169701 171284 172766 175538
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 30, 2026

LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

ALL 50 STATES
Full report

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

Recall #:
98679
Lot/product code:
LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 30, 2026

Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A

Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

ALL 50 STATES
Full report

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

Recall #:
98665
Lot/product code:
Lot Code: Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301014(10)85390029 ; Individual UDI (01)00889024376564(17)301014(10)85390029 ; Lot Number 85390029 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301103(10)85682882 ; Individual UDI (01)00889024376564(17)301103(10)85682882 ; Lot Number 85682882 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301001(10)85390028 ; Individual UDI (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300422(10)82395239 ; Individual UDI (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300423(10)82395240 ; Individual UDI (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300929(10)85390027 ; Individual UDI (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300924(10)85390026 ; Individual UDI (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300415(10)82395238 ; Individual UDI (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300922(10)85390025 ; Individual UDI (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300826(10)85390022 ; Individual UDI (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300918(10)85390024 ; Individual UDI (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300722(10)85390023 ; Individual UDI (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)310122(10)86970970 ; Individual UDI (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Includes an incorrect screw seat interface.

Full report

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

Recall #:
98681
Lot/product code:
Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00.
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

ALL 50 STATES
Full report

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

Recall #:
98644
Lot/product code:
Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462
Recalling firm:
Micro-X Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenEggHazelnutSoyUndeclaredRecalled March 27, 2026

Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles

Contains not listed on the label egg, soy, and hazelnut

Full report

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

Recall #:
H-0663-2026
Lot/product code:
100 count bottles - UPC: 693465524114,693465000083 Lot: 25E04-A, 25E04-B, 25E04 Expiration date: 05/27 200 count bottles - UPC:693465524213,693465000090 Lot: 25E04-B Expiration date: 05/27
Recalling firm:
Blueroot Health, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 27, 2026

Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

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-0421-2026
Lot/product code:
Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
Recalling firm:
Appco Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 27, 2026

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

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-0419-2026
Lot/product code:
Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.
Recalling firm:
Appco Pharma LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

ALL 50 STATES
Full report

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

Recall #:
98633
Lot/product code:
All Lots/UDI:0690103D004EVD000V5
Recalling firm:
Edwards Lifesciences, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 27, 2026

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

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-0420-2026
Lot/product code:
Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Recalling firm:
Appco Pharma LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 27, 2026

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

Includes an incorrect screw seat interface.

Full report

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

Recall #:
98681
Lot/product code:
Article 010.0158. UDI: (01)07630031759764(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00622_00_b00, 28000US_00431_00_b00, 28000US_00489_00_b00, 28000US_00792_00_b00, 28000US_00908_00_b00, 28000US_00908_01_b00.
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

Neutralization Buffer may contain contaminants

ALL 50 STATES
Full report

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

Recall #:
98702
Lot/product code:
Lot: F5061154/UDI: 00816387021091
Recalling firm:
Immuno-Mycologics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00840682118552; Serial Numbers:REVVX2300007CN 443327CN2 REVVX1600034CN REVVX2400004CN REVVX2200047CN 441716CN8 00000440713CN6 REVVX1800043CN 441839CN8 REVVX1700067CN REVVX1800007CN REVVX1800105CN REVVX1800048CN REVVX1900123CN REVVX1800046CN REVVX2000005CN REVVX2200009CN REVVX1600013CN REVVX1700101CN REVVX2200025CN REVVX2100028CN REVVX1900069CN REVVX2100020CN REVVX2100014CN REVVX2100050CN REVVX1600052CN 438902CN9 REVVX1900107CN 438369CN1 REVVX1900018CN REVVX1700071CN REVVX1700082CN 442792CN8 REVVX2200007CN REVVX1700104CN REVVX2000056CN REVVX1900086CN REVVX2200039CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00840682146173; Serial Numbers: AS10G2200136YC AS10G2200101YC AS10G2200068YC AS10G2200035YC AS10G2300093YC AS10G2400094YC AS10G2400079YC AS10G2100008YC AS10G2500002YC CBDWG2400019HM CBDWG2300081HM AS10G2400056YC AS10G2400081YC AS10G2400087YC CBDWG2400117HM CBDWG2400085HM CBDWG2500003HM CBDWG2400140HM CBDWG2400126HM AS10G2200085YC AS10G2300057YC CBDWG2500011HM CBDWG2300056HM CBDWG2300041HM AS10G2300041YC
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00195278460271; Serial Numbers: REV2X2400067CN REV2X2400065CN REV2X2400046CN REV2X2400021CN REV2X2400050CN REV2X2400095CN REV2X2400078CN REV2X2300068CN REV2X2400093CN REV2X2400098CN REV2X2300091CN REV2X2300042CN REV2X2300083CN REV2X2300020CN REV2X2400068CN REV2X2400107CN REV2X2300090CN REV2X2300097CN REV2X2300003CN REV2X2400028CN REV2X2400026CN REV2X2300002CN REV2X2400027CN REV2X2400059CN REV2X2300084CN REV2X2400069CN REV2X2400063CN REV2X2400055CN REV2X2300011CN REV2X2300050CN REV2X2400048CN REV2X2300047CN REV2X2400014CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

ALL 50 STATES
Full report

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

Recall #:
98722
Lot/product code:
Model/Catalog Number: 91496 UDI-DI Code: (01)10841522106422 Serial Numbers: 1496-224669 1496-224670 1496-224657 1496-224658 1496-224659 1496-224660 1496-224661 1496-224671 1496-224673 1496-224674 1496-224675 1496-224676 1496-224677 1496-224678 1496-224679 1496-224680 1496-224681 1496-224682 1496-224683 1496-224684 1496-224685 1496-224686 1496-224687 1496-224688 1496-224689 1496-224690 1496-224691 1496-224692 1496-224693 1496-224694 1496-224695 1496-224696 1496-224697 1496-224698 1496-224699 1496-224701 1496-224702 1496-224703 1496-224704 1496-224705 1496-224706 1496-224707 1496-224708 1496-224709 1496-224710 1496-224711 1496-224712 1496-224713 1496-224714 1496-224715 1496-224716 1496-224664 1496-224665 1496-224666 1496-224667 1496-224668
Recalling firm:
Spacelabs Healthcare, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 26, 2026

Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

ALL 50 STATES
Full report

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

Recall #:
98738
Lot/product code:
UDI-DI: 00195278469700; Serial Numbers: REV242400001CN REV242400004CN REV242300006CN REV242400002CN REV242300004CN
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)