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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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)

Recalls nationwide

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

19,422 recalls found
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

ALL 50 STATES
Full report

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

Recall #:
98639
Lot/product code:
Lot Code: SW13355 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270005168
Recalling firm:
Dexcom, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781270. UDI: (01)00884838095083(21)38109, (01)00884838095083(21)17386, (01)00884838095083(21)38356, (01)00884838095083(21)34211, (01)00884838095083(21)38113, (01)00884838095083(21)17356, (01)00884838095083(21)38111, (01)00884838095083(21)74011, (01)00884838095083(21)24058, (01)00884838095083(21)24066, (01)00884838095083(21)34223. Serial Numbers: 38109, 17386, 38356, 34211, 38113, 17356, 38111, 74011, 24058, 24066, 34223. 2. Model Number (REF): 782113. UDI: (01)00884838098909(21)38066, (01)00884838098909(21)38117, (01)00884838098909(21)17384. Serial Numbers: 38066, 38117, 17384.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782118. UDI: (01)00884838099746(21)85655. Serial Numbers: 85655. 2. Model Number (REF): 782144. UDI: (01)00884838108677(21)71087. Serial Numbers: 71087. 3. Model Number (REF): 782163. UDI: (01)00884838115743(21)42299. Serial Numbers: 42299.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781260. UDI: (01)00884838095076(21)21554, (01)00884838095076(21)13018, (01)00884838095076(21)12033. Serial Numbers: 21554, 13018, 12033. 2. Model Number (REF): 782112. UDI: (01)00884838098886(21)30143, (01)00884838098886(21)22051, (01)00884838098886(21)32156. Serial Numbers: 30143, 22051, 32156.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782130. UDI: (01)00884838104402(21)45052, (01)00884838104402(21)42030, (01)00884838104402(21)42151, (01)00884838104402(21)71279, (01)00884838104402(21)71565, (01)00884838104402(21)42104, (01)00884838104402(21)42163, (01)00884838104402(21)42376, (01)00884838104402(21)45179, (01)00884838104402(21)45236, (01)00884838104402(21)45263, (01)00884838104402(21)71532, (01)00884838104402(21)85394, (01)00884838104402(21)85643, (01)00884838104402(21)85644. Serial Numbers: 45052, 42030, 42151, 71279, 71565, 42104, 42163, 42376, 45179, 45236, 45263, 71532, 85394, 85643, 85644.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782145. UDI: (01)00884838108684(21)17385. Serial Numbers: 17385.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781358. UDI: (01)00884838088115(21)45121, (01)00884838088115(21)45148, (01)00884838088115(21)45160, (01)00884838088115(21)45438, (01)00884838088115(21)45034, (01)00884838088115(21)45049, (01)00884838088115(21)45066, (01)00884838088115(21)45090, (01)00884838088115(21)45141, (01)00884838088115(21)45149, (01)00884838088115(21)45170, (01)00884838088115(21)45250, (01)00884838088115(21)45290, (01)00884838088115(21)45085, (01)00884838088115(21)45312, (01)00884838088115(21)45376, (01)00884838088115(21)45122, (01)00884838088115(21)45169, (01)00884838088115(21)45191, (01)00884838088115(21)45192, (01)00884838088115(21)45203, (01)00884838088115(21)45204, (01)00884838088115(21)45207, (01)00884838088115(21)45220, (01)00884838088115(21)45228, (01)00884838088115(21)45229, (01)00884838088115(21)45249, (01)00884838088115(21)45278, (01)00884838088115(21)45279, (01)00884838088115(21)45320, (01)00884838088115(21)45028, (01)00884838088115(21)45195, (01)00884838088115(21)45174, (01)00884838088115(21)45165, (01)00884838088115(21)45382, (01)00884838088115(21)45011, (01)00884838088115(21)45055, (01)00884838088115(21)45075, (01)00884838088115(21)45113, (01)00884838088115(21)45147, (01)00884838088115(21)45152, (01)00884838088115(21)45235, (01)00884838088115(21)45237, (01)00884838088115(21)45245, (01)00884838088115(21)45264, (01)00884838088115(21)45269, (01)00884838088115(21)45277, (01)00884838088115(21)45316, (01)00884838088115(21)45322, (01)00884838088115(21)45337, (01)00884838088115(21)45338, (01)00884838088115(21)45353, (01)00884838088115(21)45398, (01)00884838088115(21)45414, (01)00884838088115(21)45429, (01)00884838088115(21)45051. Serial Numbers: 45121, 45148, 45160, 45438, 45034, 45049, 45066, 45090, 45141, 45149, 45170, 45250, 45290, 45085, 45312, 45376, 45122, 45169, 45191, 45192, 45203, 45204, 45207, 45220, 45228, 45229, 45249, 45278, 45279, 45320, 45028, 45195, 45174, 45165, 45382, 45011, 45055, 45075, 45113, 45147, 45152, 45235, 45237, 45245, 45264, 45269, 45277, 45316, 45322, 45337, 45338, 45353, 45398, 45414, 45429, 45051. 2. Model Number (REF): 782107. UDI: (01)00884838098336(21)45590, (01)00884838098336(21)62158, (01)00884838098336(21)62180, (01)00884838098336(21)62044, (01)00884838098336(21)45567, (01)00884838098336(21)62031, (01)00884838098336(21)62166, (01)00884838098336(21)62184, (01)00884838098336(21)62190, (01)00884838098336(21)62240, (01)00884838098336(21)45519, (01)00884838098336(21)45533, (01)00884838098336(21)62024, (01)00884838098336(21)62047, (01)00884838098336(21)62048, (01)00884838098336(21)62051, (01)00884838098336(21)62052, (01)00884838098336(21)45554, (01)00884838098336(21)62145, (01)00884838098336(21)62146, (01)00884838098336(21)62148, (01)00884838098336(21)45500, (01)00884838098336(21)45501, (01)00884838098336(21)45510, (01)00884838098336(21)45511, (01)00884838098336(21)45514, (01)00884838098336(21)45516, (01)00884838098336(21)45518, (01)00884838098336(21)45589, (01)00884838098336(21)62017, (01)00884838098336(21)62039, (01)00884838098336(21)62073, (01)00884838098336(21)62081, (01)00884838098336(21)62088, (01)00884838098336(21)45521, (01)00884838098336(21)45600, (01)00884838098336(21)45563, (01)00884838098336(21)45570, (01)00884838098336(21)62153, (01)00884838098336(21)62181, (01)00884838098336(21)62182, (01)00884838098336(21)62183. Serial Numbers: 45590, 62158, 62180, 62044, 45567, 62031, 62166, 62184, 62190, 62240, 45519, 45533, 62024, 62047, 62048, 62051, 62052, 45554, 62145, 62146, 62148, 45500, 45501, 45510, 45511, 45514, 45516, 45518, 45589, 62017, 62039, 62073, 62081, 62088, 45521, 45600, 45563, 45570, 62153, 62181, 62182, 62183. 3. Model Number (REF): 782136. UDI: (01)00884838108608(21)28568, (01)00884838108608(21)28503, (01)00884838108608(21)28515, (01)00884838108608(21)28528, (01)00884838108608(21)28577. Serial Numbers: 28568, 28503, 28515, 28528, 28577.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782120. UDI: (01)00884838104112(21)65019, (01)00884838104112(21)65004, (01)00884838104112(21)65028, (01)00884838104112(21)65031, (01)00884838104112(21)65039, (01)00884838104112(21)65056, (01)00884838104112(21)65066, (01)00884838104112(21)65065, (01)00884838104112(21)65038, (01)00884838104112(21)65005, (01)00884838104112(21)65043, (01)00884838104112(21)65049, (01)00884838104112(21)65051, (01)00884838104112(21)65060. Serial Numbers: 65019, 65004, 65028, 65031, 65039, 65056, 65066, 65065, 65038, 65005, 65043, 65049, 65051, 65060. 2. Model Number (REF): 782153. UDI: (01)00884838112858(21)68034, (01)00884838112858(21)68042, (01)00884838112858(21)68014, (01)00884838112858(21)68001, (01)00884838112858(21)68007, (01)00884838112858(21)68008, (01)00884838112858(21)68017, (01)00884838112858(21)68025, (01)00884838112858(21)68037, (01)00884838112858(21)68041, (01)00884838112858(21)68019. Serial Numbers: 68034, 68042, 68014, 68001, 68007, 68008, 68017, 68025, 68037, 68041, 68019.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781342. UDI: (01)00884838055339(21)71693, (01)00884838055339(21)71581, (01)00884838055339(21)71582, (01)00884838055339(21)71607, (01)00884838055339(21)85216, (01)00884838055339(21)71106, (01)00884838055339(21)71477, (01)00884838055339(21)71512, (01)00884838055339(21)71966, (01)00884838055339(21)71967, (01)00884838055339(21)85147, (01)00884838055339(21)85224, (01)00884838055339(21)85318, (01)00884838055339(21)71462, (01)00884838055339(21)71619, (01)00884838055339(21)85250, (01)00884838055339(21)71002, (01)00884838055339(21)71037, (01)00884838055339(21)71269, (01)00884838055339(21)71841, (01)00884838055339(21)71885, (01)00884838055339(21)71897, (01)00884838055339(21)85126, (01)00884838055339(21)85109, (01)00884838055339(21)71296, (01)00884838055339(21)71188, (01)00884838055339(21)71088, (01)00884838055339(21)71387, (01)00884838055339(21)71799, (01)00884838055339(21)71040, (01)00884838055339(21)71344, (01)00884838055339(21)71583, (01)00884838055339(21)71916, (01)00884838055339(21)71368, (01)00884838055339(21)71756, (01)00884838055339(21)71822, (01)00884838055339(21)71459, (01)00884838055339(21)71022, (01)00884838055339(21)71185, (01)00884838055339(21)71286, (01)00884838055339(21)71378, (01)00884838055339(21)71646, (01)00884838055339(21)71732, (01)00884838055339(21)71612, (01)00884838055339(21)71340, (01)00884838055339(21)71336. Serial Numbers: 71693, 71581, 71582, 71607, 85216, 71106, 71477, 71512, 71966, 71967, 85147, 85224, 85318, 71462, 71619, 85250, 71002, 71037, 71269, 71841, 71885, 71897, 85126, 85109, 71296, 71188, 71088, 71387, 71799, 71040, 71344, 71583, 71916, 71368, 71756, 71822, 71459, 71022, 71185, 71286, 71378, 71646, 71732, 71612, 71340, 71336. 2. Model Number (REF): 781377. UDI: (01)00884838009813(21)42305, (01)00884838009813(21)42097, (01)00884838009813(21)42364, (01)00884838009813(21)42136, (01)00884838009813(21)42237, (01)00884838009813(21)42455, (01)00884838009813(21)42087, (01)00884838009813(21)42401, (01)00884838009813(21)42321, (01)00884838009813(21)42001, (01)00884838009813(21)42036, (01)00884838009813(21)42053, (01)00884838009813(21)42126, (01)00884838009813(21)42400. Serial Numbers: 42305, 42097, 42364, 42136, 42237, 42455, 42087, 42401, 42321, 42001, 42036, 42053, 42126, 42400. 3. Model Number (REF): 782103. UDI: (01)00884838098299(21)85672, (01)00884838098299(21)85673, (01)00884838098299(21)85674, (01)00884838098299(21)85646. Serial Numbers: 85672, 85673, 85674, 85646.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781271. UDI: (01)00884838068452(21)78017, (01)00884838068452(21)78013, (01)00884838068452(21)78014, (01)00884838068452(21)78034, (01)00884838068452(21)78058, (01)00884838068452(21)78073, (01)00884838068452(21)78075, (01)00884838068452(21)78092, (01)00884838068452(21)78112, (01)00884838068452(21)78123, (01)00884838068452(21)78201, (01)00884838068452(21)78202, (01)00884838068452(21)78215, (01)00884838068452(21)78217, (01)00884838068452(21)78239, (01)00884838068452(21)78247, (01)00884838068452(21)78260,(01)00884838068452(21)78286, (01)00884838068452(21)78287, (01)00884838068452(21)78026. Serial Numbers: 78017, 78013, 78014, 78034, 78058, 78073, 78075, 78092, 78112, 78123, 78201, 78202, 78215, 78217, 78239, 78247, 78260, 78286, 78287, 78026. 2. Model Number (REF): 782105. UDI: (01)00884838098312(21)78532, (01)00884838098312(21)78576. Serial Numbers: 78532, 78576.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781359. UDI: (01)00884838090057(21)48218, (01)00884838090057(21)48233. Serial Numbers: 48218, 48233. 2. Model Number (REF): 782108. UDI: (01)00884838098343(21)48652, (01)00884838098343(21)48551, (01)00884838098343(21)48669. Serial Numbers: 48652, 48551, 48669. 3. Model Number (REF): 782139. UDI: (01)00884838108639(21)29076, (01)00884838108639(21)29079. Serial Numbers: 29076, 29079.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781262. UDI: (01)00884838068445(21)77144. Serial Numbers: 77144.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781356. UDI: (01)00884838090040(21)47056, (01)00884838090040(21)47272, (01)00884838090040(21)47189, (01)00884838090040(21)47310, (01)00884838090040(21)47006, (01)00884838090040(21)47029, (01)00884838090040(21)47044, (01)00884838090040(21)47068, (01)00884838090040(21)47196, (01)00884838090040(21)47206, (01)00884838090040(21)47208, (01)00884838090040(21)47237, (01)00884838090040(21)47260, (01)00884838090040(21)47289, (01)00884838090040(21)47291, (01)00884838090040(21)47294, (01)00884838090040(21)47303, (01)00884838090040(21)47305, (01)00884838090040(21)47322, (01)00884838090040(21)47325, (01)00884838090040(21)47330, (01)00884838090040(21)47339, (01)00884838090040(21)47380, (01)00884838090040(21)47387. Serial Numbers: 47056, 47272, 47189, 47310, 47006, 47029, 47044, 47068, 47196, 47206, 47208, 47237, 47260, 47289, 47291, 47294, 47303, 47305, 47322, 47325, 47330, 47339, 47380, 47387. 2. Model Number (REF): 782109. UDI: (01)00884838098350(21)47869, (01)00884838098350(21)47565, (01)00884838098350(21)47644, (01)00884838098350(21)47881, (01)00884838098350(21)47509, (01)00884838098350(21)47919, (01)00884838098350(21)47634, (01)00884838098350(21)47681, (01)00884838098350(21)47706, (01)00884838098350(21)47907, (01)00884838098350(21)47867, (01)00884838098350(21)47550, (01)00884838098350(21)47804, (01)00884838098350(21)47549, (01)00884838098350(21)47635, (01)00884838098350(21)47788, (01)00884838098350(21)47617, (01)00884838098350(21)47566, (01)00884838098350(21)47597, (01)00884838098350(21)47892, (01)00884838098350(21)47893, (01)00884838098350(21)47894, (01)00884838098350(21)47534, (01)00884838098350(21)47538, (01)00884838098350(21)47554, (01)00884838098350(21)47590, (01)00884838098350(21)47642, (01)00884838098350(21)47659, (01)00884838098350(21)47726, (01)00884838098350(21)47760, (01)00884838098350(21)47761, (01)00884838098350(21)47767, (01)00884838098350(21)47771, (01)00884838098350(21)47789, (01)00884838098350(21)47799, (01)00884838098350(21)47814, (01)00884838098350(21)47835, (01)00884838098350(21)47849, (01)00884838098350(21)47862, (01)00884838098350(21)47888, (01)00884838098350(21)47929, (01)00884838098350(21)47931, (01)00884838098350(21)47950, (01)00884838098350(21)47962. Serial Numbers: 47869, 47565, 47644, 47881, 47509, 47919, 47634, 47681, 47706, 47907, 47867, 47550, 47804, 47549, 47635, 47788, 47617, 47566, 47597, 47892, 47893, 47894, 47534, 47538, 47554, 47590, 47642, 47659, 47726, 47760, 47761, 47767, 47771, 47789, 47799, 47814, 47835, 47849, 47862, 47888, 47929, 47931, 47950, 47962. 3. Model Number (REF): 782138. UDI: (01)00884838108622(21)49004, (01)00884838108622(21)49251, (01)00884838108622(21)49045, (01)00884838108622(21)49058, (01)00884838108622(21)49129, (01)00884838108622(21)49153, (01)00884838108622(21)49165, (01)00884838108622(21)49161, (01)00884838108622(21)49205, (01)00884838108622(21)49228, (01)00884838108622(21)49206, (01)00884838108622(21)49057, (01)00884838108622(21)49100, (01)00884838108622(21)49172, (01)00884838108622(21)49210, (01)00884838108622(21)49215, (01)00884838108622(21)49231. Serial Numbers: 49004, 49251, 49045, 49058, 49129, 49153, 49165, 49161, 49205, 49228, 49206, 49057, 49100, 49172, 49210, 49215, 49231. 4. Model Number (REF): 782160. UDI: (01)00884838115712(21)92039. Serial Numbers: 92039.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled April 14, 2026

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

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-0490-2026
Lot/product code:
Lot #: 640911253, Exp Date. 09/14/2027.
Recalling firm:
Premier Dental Products Co
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781196. UDI: None. Serial Numbers: 21957. 2. Model Number (REF): 781296. UDI: (01)00884838004108(21)32039, (01)00884838004108(21)32095. Serial Numbers: 32039, 32095.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781357. UDI: (01)00884838088108(21)46002. Serial Numbers: 46002. 2. Model Number (REF): 782106. UDI: (01)00884838098329(21)46243, (01)00884838098329(21)46292, (01)00884838098329(21)46317. Serial Numbers: 46243, 46292, 46317. 3. Model Number (REF): 782137. UDI: (01)00884838108615(21)64034, (01)00884838108615(21)64045. Serial Numbers: 64034, 64045.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782143. UDI: (01)00884838108660(21)42218, (01)00884838108660(21)42225. Serial Numbers: 42218, 42225. 2. Model Number (REF): 782162. UDI: (01)00884838115736(21)71403. Serial Numbers: 71403.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

ALL 50 STATES
Full report

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

Recall #:
98639
Lot/product code:
Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 00386270004307
Recalling firm:
Dexcom, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781278. UDI: (01)00884838004139(21)38103. Serial Numbers: 38103.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781315. UDI: (01)00884838099715(21)61067, (01)00884838099715(21)61058, (01)00884838099715(21)61056. Serial Numbers: 61067 61058, 61056. 2. Model Number (REF): 781341. UDI: (01)00884838055322(21)70229, (01)00884838055322(21)84667, (01)00884838055322(21)70311, (01)00884838055322(21)70668, (01)00884838055322(21)70845, (01)00884838055322(21)70851, (01)00884838055322(21)87151, (01)00884838055322(21)87112, (01)00884838055322(21)84322, (01)00884838055322(21)84323, (01)00884838055322(21)84228, (01)00884838055322(21)84789, (01)00884838055322(21)84261, (01)00884838055322(21)84500, (01)00884838055322(21)84556, (01)00884838055322(21)87187, (01)00884838055322(21)84840, (01)00884838055322(21)70685, (01)00884838055322(21)84661, (01)00884838055322(21)70787, (01)00884838055322(21)70063, (01)00884838055322(21)70621, (01)00884838055322(21)70743, (01)00884838055322(21)70911, (01)00884838055322(21)84049, (01)00884838055322(21)84088, (01)00884838055322(21)84147, (01)00884838055322(21)84254, (01)00884838055322(21)84283, (01)00884838055322(21)84403, (01)00884838055322(21)84433, (01)00884838055322(21)84460, (01)00884838055322(21)84462, (01)00884838055322(21)84467, (01)00884838055322(21)84475, (01)00884838055322(21)84734, (01)00884838055322(21)84538. Serial Numbers: 70229, 84667, 70311, 70668, 70845, 70851, 87151, 87112, 84322, 84323, 84228, 84789, 84261, 84500, 84556, 87187, 84840, 70685, 84661, 70787, 70063, 70621, 70743, 70911, 84049, 84088, 84147, 84254, 84283, 84403, 84433, 84460, 84462, 84467, 84475, 84498, 84538. 3. Model Number (REF): 781396. UDI: (01)00884838009820(21)41175, (01)00884838009820(21)41108, (01)00884838009820(21)41395, (01)00884838009820(21)41037, (01)00884838009820(21)41066, (01)00884838009820(21)41098, (01)00884838009820(21)41194, (01)00884838009820(21)41208, (01)00884838009820(21)41354, (01)00884838009820(21)41356, (01)00884838009820(21)41370, (01)00884838009820(21)41552. Serial Numbers: 41175, 41108, 41395, 41037, 41066, 41098, 41194, 41208, 41354, 41356, 41370, 41552. 4. Model Number (REF): 782115. UDI: (01)00884838099043(21)61214, (01)00884838099043(21)61221. Serial Numbers: 61214, 61221.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782116. UDI: (01)00884838099722(21)41527, (01)00884838099722(21)70949, (01)00884838099722(21)84741. Serial Numbers: 41527, 70949, 84741. 2. Model Number (REF): 782148. UDI: (01)00884838108714(21)84560, (01)00884838108714(21)41277, (01)00884838108714(21)70769, (01)00884838108714(21)70983. Serial Numbers: 84560, 41277, 70769, 70983. 3. Model Number (REF): 782166. UDI: (01)00884838115774(21)70042. Serial Numbers: 70042.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

ALL 50 STATES
Full report

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781178. UDI: None. Serial Numbers: 20088.
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 13, 2026

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.

ALL 50 STATES
Full report

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

Recall #:
98418
Lot/product code:
Device/UDI/Serial Number: LIFEPAK 15/0088387391164815011543166573, 0088387387169015033143394891, 0088387387169015050743524360, 0088387387169015092843914574, 0088387387204815093043915122, 0088387387169016010444187447, 0088387387162116012044252611, 0088387387169016012644262721, 0088387387169016012644277082, 0088387387169016012744282280, 0088387387171316060244574340, 0088387387171316080444896329, 0088387387169016083144962804, 0088387387170617013145447229, 0088387387169017041245743786, 0088387387171317050945834209, 0088387387171317062845998142, 0088387387171317082846103043, 0088387387169017101046303288, 0088387387171317103146303092, 0088387387162117122146587130, 0088387387171317122646602003, 0088387387171317122846608783, 0088387387171317122946614788, 0088387387171318022246813507, 0088387387169018032946966267, 0088387387171318061947337396, 0088387387169018070547401928, 0088387387171318092747611441, 0088387387169018112947784931, 0088387387169018112947786317, 0088387387171318121847847661, 0088387387171318121847848950, 0088387387708118121947845317, 0088387387708118121947855371, 0088387387169018122047857172, 0088387387169018122047858660, 0088387387171318122847872868, 0088387387171319031248018370, 0088387387169019061248247559, 0088387387168319062748298704, 0088387387169019100848453060, 0088387387171319101448455890, 0088387387171319121848586351, 0088387387171319121948586599, 0088387387168320012848651507, 0088387387171320030548701689, 0088387387708120042848784975, 0088387387171320071648887706, 0088387387168320081748921846, 0088387387169020092448981398, 0088387387169020102649032288, 0088387387169020102649050140, 0088387387162120110249055931, 0088387387168320122949156402, 0088387387169021011149162067, 0088387387169021011149167463, 0088387387169021013049212578, 0088387387169021020949225869, 0088387387169021020949226060, 0088387387176821021949240566, 0088387387168321033149345530, 0088387387169021042149378981, 0088387387169021042649381781, 0088387387169021042749381576, 0088387387168321081849559854, 0088387387168321081949560127, 0088387387164521091649607224, 0088387387171321102149662806, 0088387377697122070750045009, 0088387387169022090150136719, 0088387387171322090850152289, 0088387387708122091350158293, 0088387387169022101950223934, 0088387387708122112150288760, 0088387387171322120150307353, 0088387387169023062850629377, 0088387387169023072450653772, 0088387387169023072450667197, 0088387387708123072850669746, 0088387387708123082850714419, 0088387387171323082950720588, 0088387387169023112150850129, 0088387387708123122050883524, 0088387388434824052251092313, 0088387387170624121151422867, 0088387387170624122351440213, 0088387387170624122351444039, 0088387388434824052251092313, 0088387387169019100848453060, 0088387387201715090843839264, 0088387387171318121847850793/ 38523489, 39736196, 40465345, 40717931, 40765749, 41130420, 41139184, 41420681, 41446039, 41446693, 41704583, 42221131, 42920956, 42921954, 43166573, 43394891, 43524360, 43914574, 43915122, 44187447, 44252611, 44262721, 44277082, 44282280, 44574340, 44896329, 44962804, 45447229, 45743786, 45834209, 45998142, 46103043, 46303288, 46303092, 46587130, 46602003, 46608783, 46614788, 46813507, 46966267, 47337396, 47401928, 47611441, 47784931, 47786317, 47847661, 47848950, 47845317, 47855371, 47857172, 47858660, 47872868, 48018370, 48247559, 48298704, 48453060, 48455890, 48586351, 48586599, 48651507, 48701689, 48784975, 48887706, 48921846, 48981398, 49032288, 49050140, 49055931, 49156402, 49162067, 49167463, 49212578, 49225869, 49226060, 49240566, 49345530, 49378981, 49381781, 49381576, 49559854, 49560127, 49607224, 49662806, 50045009, 50136719, 50152289, 50158293, 50223934, 50288760, 50307353, 50629377, 50653772, 50667197, 50669746, 50714419, 50720588, 50850129, 50883524, 51092313, 51422867, 51440213, 51444039, 51092313, 48453060, 43839264, 47850793, 38369584. LIFEPAK 1000/0088507469887815020943235807, 0088507469895315031343346860, 0088507469887815111944068667, 0088507469887815111944068669, 0088507469895316011844239775, 0088507469887816041444539726, 0088507469887817061745966118, 0088507469887817061745966121, 0088507469887817061745966122, 0088507469887817061745966126, 0088507469887817061945966131, 0088507469887817062945994506, 0088507469887817062946004311, 0088507469887817063046012479, 0088507469887818060547291148, 0088387381546519080648366102, 0088387381545820092948987376, 0088387381545821011249174469, 0088387381545821081349544565, 0088387381545821090249586700, 0088387381546521122249752235, 0088387381545822012649794992, 0088387381545822032949882696, 0088387381545822032949882698, 0088387381545822032949882819/ 34933095, 35096556, 35184465, 36153943, 36199099, 36560529, 36560531, 37119097, 37226402, 37330295, 38074718, 38074722, 38074727, 38074737, 38074741, 38074744, 38074745, 38074747, 38074748, 38074749, 38077938, 38077939, 38077940, 38077941, 38077944, 38378802, 38513659, 38656117, 38656121, 38656122, 38957375, 38957392, 38957397, 38957399, 38957402, 38972629, 38972677,… (truncated, 6054 characters total — see the official FDA record for the full value)
Recalling firm:
Physio-Control, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 13, 2026

Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)

Nitrile Exam Glove failed to meet specifications chemical permeation performance.

ALL 50 STATES
Full report

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

Recall #:
98805
Lot/product code:
REF: 48771/UDI: 30680651487712 (Package)20680651487715 (Primary)90680651487714 (Unit of Use) ; 48772/30680651487729 (Package)20680651487722 (Primary)90680651487721 (Unit of Use);48773/30680651487736 (Package)20680651487739 (Primary)90680651487738 (Unit of Use);48774/UDI: 30680651487743 (Package)20680651487746 (Primary) 90680651487745 (Unit of Use);48775/UDI:30680651487750 (Package)20680651487753 (Primary)90680651487752 (Unit of Use)
Recalling firm:
O&M HALYARD INC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled April 13, 2026

52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), sucralose (E955), allura red (E129), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 10185 42123 7

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

Full report

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

Recall #:
H-0676-2026
Lot/product code:
Lot Numbers: 20250813 Expiration Date: Feb 8, 2027
Recalling firm:
Guangdong Zonegoing Food Co., LTD
View official FDA record (opens in a new tab)