BIGNOPE
Ko-fi

Recalls affecting Alaska

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

16,261 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
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 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 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 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 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 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

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 13, 2026

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

Due to incorrect incubation process being performed on product.

ALL 50 STATES
Full report

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

Recall #:
98695
Lot/product code:
Lot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the previous recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs.
Recalling firm:
HF Acquisition Co LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 13, 2026

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

Due to incorrect incubation process being performed on product.

ALL 50 STATES
Full report

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

Recall #:
98695
Lot/product code:
Lot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs. Product/Item Number: 1023780 UDI-DI code: 00850065007496 Lot Numbers: DSS-122 DSS-125 DSS-128 DSS-131 DSS-134
Recalling firm:
HF Acquisition Co LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 13, 2026

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

Due to incorrect incubation process being performed on product.

ALL 50 STATES
Full report

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

Recall #:
98695
Lot/product code:
Lot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the previous recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs.
Recalling firm:
HF Acquisition Co LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 13, 2026

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

Due to incorrect incubation process being performed on product.

ALL 50 STATES
Full report

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

Recall #:
98695
Lot/product code:
Lot Code: Please see attached spreadsheet listing products that were not incubated per the following requirements : a. Spore strips used in steam sterilizers are incubated for 24 hours b. Spore strips used in chemiclave sterilizers are incubated for 72 hours c. Spore strips used in dry heat or ethylene oxide sterilizers are incubated for 7 days As noted in the recall scope question, HealthFirst's Field Correction scope will be expanded to include notifications to all customers in possession of 1023780 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS,1023770 SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS or other products serviced by Mesa Labs. Product/Item Number: 1023780 UDI-DI code: 00850065007496 Lot Numbers: DSS-122 DSS-125 DSS-128 DSS-131 DSS-134
Recalling firm:
HF Acquisition Co LLC
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)
UnclassifiedRisk not yet known
Medical deviceRecalled April 13, 2026

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).

ALL 50 STATES
Full report

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

Recall #:
98417
Lot/product code:
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 Serial Numbers: 30100846 30112125 30123845 30124348 30124440 30124475 30124991 30136605 30148155 30148365 3015B568 3015B682 3015C276 3015C722 3015C723 3015C724 3015F246 3015F587 3016G845 3016H983 3017K078 3017K079 3017K080 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 Serial Numbers: 35160778 35173272 35173461 35185820 35185817 35175040 35175039 35173347 35160921 35175373 35174279 35172701 35161449 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 Serial Numbers: 3520R763 3522AN95 3519F615 3520N419 3522DK48 3521S574 3521T901 3520R187 3518B300 3522EG06 3520P749 3520R206 3520S005 3520P512 3520P691 3520P741 3520P742 3520P744 3520P745 3520P746 3520P748 3520P810 3520S006 3520P747 3520S003 3521AF21 3518B131 3520L408 3519E743 3521AC18 3521U379 3520O364 3520S292 3519F035 3520S149 3521Z495 3521Z496 3520P082 3520L957 3520R180 3519G235 3519G633 3519H568 3519E607 3522BI32 3518D028 3522CN47 3520K867 3519I425 3520K923 3523FA45 3520O771 3520R123 3521W020 3520K966 3522AV78 3521T568 3520O776 3518A707 3521T325 3521T329 3518C485 3518D396 3522BU41 3519G180 3522AR04 3522AR05 3520R135 3522CR96 3523EN71 3520R209 3520L915 3520L916 3520N979 3520O026 3520O298 3520P109 3520P559 3520S287 3521V691 3522AR01 3522AR03 3518D017 3519E728 3520N729 3519F039 3520L676 3520N364 3520N366 3521S486 3520P539 3521V200 3522BZ70 3523FL02 3523FL03 3521T704 3521T575 3520O549 3520P906 3520P928 3520P930 3522AR07 3520R138 3523EN74 3521V688 3519F034 3523FA47 3520P907 3520S285 3521S487 3522AR00 3522AR06 3523FD33 3519F038 3523FH21 3520N010 3520N505
Recalling firm:
Jolife AB
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)
Class IIILow risk
DrugRecalled April 13, 2026

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.

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-0511-2026
Lot/product code:
Lot: ZBUL25001, Exp 12/31/2027
Recalling firm:
Unichem Pharmaceuticals USA Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 07613327357301, Lot Numbers: 2934107, 3695884, 3813841, 3963557, 4293648, 4660245, 4816422, 4937844, 4984006, 5024442, 2964378, 3695885, 3813842, 3963558, 4294641, 4665924, 4816423, 4937846, 4984751, 5024443, 3369649, 3695886, 3813843, 3963559, 4320451, 4665926, 4820652, 4937850, 4985810, 5025866, 3414030, 3695889, 3813844, 3963561, 4320454, 4677505, 4824140, 4937853, 4985813, 5025908, 3487957, 3695898, 3814084, 3963565, 4320584, 4683574, 4824141, 4937876, 4985814, 5025909, 3487959, 3695899, 3814089, 3963923, 4320585, 4690460, 4824142, 4937886, 4985819, 5025913, 3516565, 3695905, 3814090, 3965856, 4352366, 4690461, 4824143, 4937914, 4985820, 5030283, 3516579, 3695909, 3814151, 3971195, 4365471, 4722597, 4824144, 4937921, 4985977, 5030284, 3533495, 3695911, 3814152, 3971196, 4365472, 4722598, 4825584, 4937937, 4985978, 5030285, 3536146, 3695912, 3814379, 3971197, 4371818, 4734903, 4825590, 4938070, 4985980, 5030306, 3563129, 3713425, 3814402, 3971199, 4380641, 4742839, 4828929, 4938075, 4986540, 5030308, 3623660, 3720912, 3814403, 3971200, 4384663, 4770976, 4829405, 4940572, 4990713, 5030309, 3635399, 3720913, 3814404, 3971363, 4384664, 4770977, 4829407, 4940573, 4990727, 5034157, 3639136, 3720914, 3814405, 3991716, 4384665, 4774463, 4829408, 4940574, 4992829, 5034251, 3642928, 3720915, 3814406, 4000629, 4384666, 4774464, 4829409, 4940575, 4998446, 5036560, 3657002, 3720916, 3814407, 4018409, 4384667, 4776002, 4830745, 4952872, 4998448, 5036561, 3657003, 3720919, 3814408, 4020134, 4384668, 4776023, 4830748, 4953149, 4998547, 5040068, 3658634, 3733771, 3814409, 4068043, 4390632, 4799861, 4833289, 4953150, 4998548, 5041755, 3658673, 3741542, 3814410, 4111059, 4400780, 4799862, 4840236, 4953151, 5002404, 5041756, 3659104, 3743987, 3824661, 4115291, 4406069, 4799863, 4841977, 4953153, 5002405, 5041760, 3665462, 3748109, 3824662, 4142838, 4423866, 4800152, 4841978, 4953154, 5002602, 5043056, 3665463, 3766803, 3831087, 4142840, 4423870, 4800155, 4842198, 4953155, 5002603, 5043824, 3665464, 3766807, 3841170, 4142841, 4428699, 4800353, 4842783, 4953156, 5002604, 5043825, 3665465, 3766808, 3843536, 4144673, 4428700, 4801216, 4846033, 4953157, 5002605, 5052577, 3665466, 3770489, 3845330, 4144997, 4438106, 4806963, 4852908, 4953162, 5008310, 5059783, 3670655, 3774007, 3851621, 4181100, 4450156, 4806964, 4854158, 4953183, 5008392, 5059784, 3670656, 3778766, 3851622, 4181101, 4495768, 4806965, 4855585, 4953184, 5008394, 5059785, 3670659, 3778767, 3851623, 4181102, 4498972, 4806966, 4855586, 4960862, 5008412, 5059786, 3670662, 3778769, 3851624, 4199249, 4500710, 4808371, 4855669, 4973101, 5008704, 5059787, 3670665, 3788271, 3851625, 4200117, 4512636, 4811617, 4859421, 4973653, 5008705, 5059788, 3670666, 3792023, 3851626, 4218160, 4519621, 4813305, 4859422, 4978434, 5008750, 5059789, 3684410, 3805982, 3888520, 4225232, 4548019, 4813306, 4865886, 4978435, 5008751, 5067006, 3684411, 3809170, 3888521, 4232774, 4593743, 4813307, 4868858, 4979809, 5017528, 5078231, 3684412, 3809184, 3888524, 4265339, 4617777, 4813310, 4871606, 4979810, 5017529, 5078232, 3691269, 3809306, 3895233, 4265852, 4623978, 4813611, 4871607, 4980427, 5017533, 5081439, 3693634, 3809307, 3944996, 4281497, 4636786, 4813612, 4871608, 4980429, 5017536, 5081440, 3695835, 3811477, 3944997, 4281516, 4637499, 4814211, 4871609, 4980430, 5017539, 5081441, 3695836, 3811480, 3944998, 4281899, 4643511, 4814213, 4871610, 4980836, 5017541, 5083240, 3695850, 3813705, 3953668, 4282025, 4651653, 4814221, 4872209, 4980837, 5021604, 5083242, 3695852, 3813706, 3960483, 4282026, 4653186, 4814228, 4937761, 4980838, 5021606, 5085978, 3695865, 3813707, 3963551, 4282027, 4655459, 4814231, 4937764, 4980870, 5021607, 3695866, 3813708, 3963553, 4282248, 4656625, 4816416, 4937771, 4982864, 5022826, 3695873, 3813709, 3963555, 4282965, 4659207, 4816418, 4937832, 4984004, 5024439, 3695876, 3813839, 3963556, 4292165, 4659209, 4816419, 4937843, 4984005, 5024440.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825003838, Lot Numbers: 4225215, 4653836, 4793147, 4852429, 4986000, 5023873, 5043553, 4280561, 4672798, 4799184, 4852603, 4986001, 5023874, 5043556, 4287896, 4677462, 4799186, 4854910, 4986002, 5023875, 5043560, 4296580, 4677463, 4799187, 4856657, 4997834, 5023876, 5053722, 4309622, 4693434, 4799188, 4860078, 5003556, 5027296, 5059498, 4309623, 4693435, 4799191, 4860082, 5003557, 5027297, 5059499, 4309846, 4693436, 4799309, 4861298, 5003558, 5027301, 5064680, 4374217, 4693437, 4800061, 4861536, 5003569, 5027406, 5064916, 4396650, 4728693, 4800062, 4939136, 5004167, 5027407, 5071434, 4458557, 4728695, 4800113, 4953662, 5004181, 5027571, 5072250, 4479919, 4733707, 4801993, 4953663, 5007874, 5028963, 5073207, 4497169, 4755043, 4801994, 4963413, 5009259, 5030330, 5073552, 4507933, 4755045, 4807495, 4963414, 5013933, 5031863, 5083312, 4510607, 4755046, 4808706, 4963418, 5013934, 5032745, 5083313, 4551972, 4755047, 4808707, 4966281, 5013949, 5038102, 5084295, 4566389, 4762910, 4809527, 4968920, 5013956, 5038314, 5085197, 4585687, 4773741, 4811620, 4968921, 5016583, 5038317, 4600586, 4777739, 4811622, 4974743, 5016616, 5038318, 4613364, 4786928, 4811625, 4976214, 5018038, 5038321, 4613429, 4786931, 4829506, 4976215, 5018718, 5038782, 4614815, 4793146, 4829507, 4985998, 5020889, 5043552.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825011529, Lot Numbers: 3881385, 4808385, 4854113, 4961672, 4974217, 4988584, 4993237, 5016458, 5021634, 5048549, 3921444, 4822971, 4945780, 4961673, 4979107, 4988587, 4994122, 5016460, 5021635, 5050589, 3998693, 4822986, 4945781, 4961674, 4981313, 4988751, 4994128, 5016461, 5021636, 5053395, 4029481, 4822987, 4953683, 4970070, 4982419, 4988752, 4994180, 5016462, 5021637, 5053396, 4369183, 4824246, 4954241, 4970071, 4982421, 4988753, 4998213, 5016463, 5021639, 5060170, 4369245, 4824248, 4961385, 4970361, 4983569, 4988754, 4998214, 5016464, 5021640, 5060171, 4732484, 4824249, 4961665, 4970362, 4986061, 4988755, 5005259, 5016466, 5021641, 5060172, 4751084, 4828822, 4961666, 4970363, 4986062, 4988756, 5005263, 5017692, 5025098, 5060173, 4796276, 4837793, 4961667, 4970364, 4986063, 4990589, 5005264, 5017935, 5025100, 5060174, 4798223, 4846389, 4961668, 4970365, 4986064, 4990590, 5011152, 5018675, 5025101, 5086587, 4801020, 4853335, 4961669, 4970366, 4986065, 4990591, 5014700, 5018677, 5036101, 5086588, 4801021, 4853336, 4961670, 4970367, 4986067, 4990592, 5014702, 5020792, 5042591, 5086590, 4808376, 4854112, 4961671, 4970368, 4986068, 4992498, 5016457, 5021633, 5045829, 5086592.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825006877, Lot Numbers: 3683857, 3836878, 3981321, 4042778, 4053585, 4103495, 4496897, 3683858, 3891551, 3991434, 4052721, 4053586, 4111212, 4496898, 3694871, 3932470, 3991439, 4052723, 4103479, 4111213, 4549309, 3762375, 3942462, 3991442, 4052726, 4103480, 4111214, 4549312, 3764605, 3964790, 3991444, 4052727, 4103481, 4111216, 4570926, 3764606, 3971860, 3991445, 4052735, 4103482, 4111218, 4570936, 3767575, 3973797, 4042769, 4052747, 4103483, 4111219, 4749790, 3767954, 3981001, 4042773, 4053579, 4103491, 4496884, 4753244, 3769052, 3981005, 4042776, 4053580, 4103492, 4496886, 4954168, 3808357, 3981320, 4042777, 4053582, 4103493, 4496892.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825005528, Lot Numbers: 3495675, 4117216, 4330131, 4471121, 4553575, 4630179, 4768595, 4821705, 4954755, 5043512, 3684287, 4129638, 4334639, 4471122, 4554838, 4630180, 4773075, 4821706, 4954759, 5043513, 3691298, 4145046, 4334644, 4474949, 4555860, 4634858, 4793018, 4821707, 4961661, 5043514, 3763763, 4150788, 4334650, 4474951, 4556028, 4634859, 4793019, 4821708, 4971101, 5043515, 3775492, 4175981, 4355098, 4474952, 4569198, 4634860, 4793020, 4822439, 4971102, 5043518, 3775494, 4179878, 4359156, 4479369, 4569199, 4635785, 4793021, 4822440, 4973758, 5045769, 3784070, 4184227, 4359191, 4479371, 4569215, 4635862, 4793022, 4822455, 4974714, 5045901, 3792331, 4186482, 4359418, 4483403, 4570262, 4640440, 4794757, 4830178, 4976272, 5050564, 3794912, 4188323, 4367362, 4483440, 4576849, 4640444, 4794787, 4830179, 4976273, 5050565, 3794915, 4188326, 4367363, 4484604, 4581614, 4645476, 4794789, 4830180, 4976274, 5050573, 3812435, 4201950, 4375667, 4484728, 4583794, 4649445, 4795050, 4830611, 4976275, 5052378, 3822411, 4206043, 4375668, 4484730, 4583795, 4649447, 4795052, 4837569, 4981738, 5056092, 3828557, 4217802, 4375670, 4494938, 4590093, 4666121, 4798012, 4841236, 4981739, 5056098, 3834570, 4223058, 4379438, 4500899, 4599370, 4670683, 4798893, 4842482, 4981741, 5056146, 3856651, 4223059, 4385998, 4500900, 4601759, 4670686, 4798894, 4849535, 4981743, 5056156, 3860662, 4226233, 4386193, 4500901, 4604044, 4670692, 4798895, 4849538, 4983562, 5056157, 3900656, 4234978, 4386196, 4524162, 4606184, 4670695, 4798896, 4854912, 4985073, 5056158, 3947356, 4246621, 4386199, 4528392, 4607129, 4684581, 4798897, 4858801, 4985074, 5056159, 3980664, 4247945, 4386213, 4528394, 4608446, 4689653, 4798898, 4858803, 4985075, 5071158, 3989350, 4252214, 4386219, 4530056, 4614402, 4690469, 4798899, 4858807, 4999738, 5071162, 4004245, 4254255, 4386220, 4530068, 4615032, 4733158, 4803865, 4865777, 5018016, 5073737, 4014734, 4254258, 4390069, 4530069, 4615533, 4733159, 4804015, 4866488, 5018018, 5073738, 4018502, 4262594, 4390076, 4533342, 4615535, 4733161, 4807052, 4866489, 5018019, 5073739, 4057460, 4275962, 4405109, 4534882, 4616911, 4733162, 4813125, 4866513, 5018022, 5073740, 4058912, 4277371, 4406133, 4534883, 4616912, 4733163, 4813133, 4873157, 5018023, 5077981, 4074970, 4282261, 4406134, 4539283, 4618308, 4737222, 4813140, 4873158, 5018498, 5077982, 4081932, 4287761, 4427706, 4539287, 4619851, 4745906, 4817687, 4875001, 5021780, 5077984, 4084034, 4294841, 4435823, 4539290, 4619854, 4745907, 4817689, 4883359, 5038794, 5081366, 4095939, 4302829, 4452359, 4539291, 4619856, 4745908, 4817690, 4896357, 5042549, 5087199, 4097365, 4325230, 4459673, 4553565, 4619863, 4764244, 4817693, 4945462, 5043510, 4097366, 4325232, 4464301, 4553566, 4621608, 4767000, 4821704, 4954754, 5043511.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825007287, Lot Numbers: 3459566, 3623281, 4191726.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

ALL 50 STATES
Full report

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

Recall #:
98837
Lot/product code:
Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMH714; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMF179; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25IMI476; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25GME934; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24JMA156; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24IMG162; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23IBG784; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBG512; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBA325; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 26AMK307; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25LME383; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25JMJ632; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMI508; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMB093; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25GMB270; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMD040; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMB958; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMD548; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMA551; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24GMI471; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24DBA515; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24BBQ043; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23IBH382; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23GBD403; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 26BMH362; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25LMC760; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25JME361; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25IMI413; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMH140; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMA304; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25GMB268; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25FMF696; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25DMJ266; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB245; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB241; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24GMB114; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24BME560; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25KMD376; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25JMC383; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25FMH538; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24KDB290; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24EDB889; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 23JDC308; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 26ABW292; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25KBT852; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25JBR203; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBS729; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBJ284; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25EBD163; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24EDB670; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24CDA047; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number … (truncated, 7793 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

ALL 50 STATES
Full report

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

Recall #:
98837
Lot/product code:
Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25DMF105; Medline Kit SKU DYNJRA1181C: UDI/DI 10193489457605 each, 40193489457606 case, Lot Number 25CMB575; Medline Kit SKU DYNJRA1860: UDI/DI 10195327008413 each, 40195327008414 case, Lot Number 24DMB099.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825003869, Lot Numbers: 3975235, 4253785, 4277547, 4297459, 4656095, 4818154, 4972266, 4065815, 4253786, 4277548, 4297460, 4656096, 4818155, 5032390, 4180953, 4253791, 4296975, 4363237, 4717623, 4818156, 5032392, 4223973, 4254918, 4296977, 4404427, 4717624, 4831929, 5032393, 4253773, 4254919, 4296978, 4481136, 4717625, 4831931, 5032394, 4253774, 4254921, 4296979, 4494845, 4742015, 4836645, 5032395, 4253775, 4254922, 4296980, 4542475, 4742017, 4836646, 5032710, 4253778, 4254923, 4296981, 4544586, 4742018, 4858708, 5055855, 4253779, 4277541, 4296982, 4545898, 4788864, 4858709, 5055858, 4253782, 4277544, 4297456, 4656082, 4788865, 4881310, 5073042, 4253783, 4277545, 4297457, 4656093, 4788866, 4967746, 5079052, 4253784, 4277546, 4297458, 4656094, 4807750, 4972265.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

ALL 50 STATES
Full report

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

Recall #:
98837
Lot/product code:
Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)