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Recalls affecting Connecticut

Data last updated: September 11, 2026 at 1:08 PM UTC

16,780 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

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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.

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/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

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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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.

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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

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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

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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 December 12, 2025

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

ALL 50 STATES
Full report

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

Recall #:
98096
Lot/product code:
Software Versions: R2.1.10 and R2.2.10. 1. Model Number (UDI): 722063 ((01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)153, (01)00884838085275(21)69, (01)00884838085275(21)154, (01)00884838085275(21)97, (01)00884838085275(21)137, (01)00884838085275(21)116, (01)00884838085275(21)127, (01)00884838085275(21)151, (01)00884838085275(21)148, (01)00884838085275(21)150, (01)00884838085275(21)146, (01)00884838085275(21)149, (01)00884838085275(21)123, (01)00884838085275(21)130, (01)00884838085275(21)143, (01)00884838085275(21)139, (01)00884838085275(21)144, (01)00884838085275(21)145, (01)00884838085275(21)141, (01)00884838085275(21)140, (01)00884838085275(21)135, (01)00884838085275(21)133, (01)00884838085275(21)107, (01)00884838085275(21)120, (01)00884838085275(21)129, (01)00884838085275(21)105, (01)00884838085275(21)110, (01)00884838085275(21)128, (01)00884838085275(21)119, (01)00884838085275(21)113, (01)00884838085275(21)43, (01)00884838085275(21)117, (01)00884838085275(21)115, (01)00884838085275(21)101, (01)00884838085275(21)94, (01)00884838085275(21)106, (01)00884838085275(21)103, (01)00884838085275(21)99, (01)00884838085275(21)102, (01)00884838085275(21)104, (01)00884838085275(21)100, (01)00884838085275(21)80, (01)00884838085275(21)81, (01)00884838085275(21)89, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)82, (01)00884838085275(21)87, (01)00884838085275(21)93, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)79, (01)00884838085275(21)83, (01)00884838085275(21)76, (01)00884838085275(21)77, (01)00884838085275(21)78, (01)00884838085275(21)70, (01)00884838085275(21)53, (01)00884838085275(21)72, (01)00884838085275(21)63, (01)00884838085275(21)71, (01)00884838085275(21)73, (01)00884838085275(21)62, (01)00884838085275(21)50, (01)00884838085275(21)59, (01)00884838085275(21)54, (01)00884838085275(21)61, (01)00884838085275(21)52, (01)00884838085275(21)55, (01)00884838085275(21)40, (01)00884838085275(21)51, (01)00884838085275(21)48, (01)00884838085275(21)47, (01)00884838085275(21)46, (01)00884838085275(21)44, (01)00884838085275(21)41, (01)00884838085275(21)38, (01)00884838085275(21)29, (01)00884838085275(21)27, (01)00884838085275(21)28, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)26, (01)00884838085275(21)25, (01)00884838085275(21)30, (01)00884838085275(21)21, (01)00884838085275(21)24, (01)00884838085275(21)22, (01)00884838085275(21)19, (01)00884838085275(21)23, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)15, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)3, (01)00884838085275(21)2, (01)00884838085275(21)4, (01)00884838085275(21)121), 722221 ((01)00884838099203(21)181, (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838099203(21)178, (01)00884838099203(21)54, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)177, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)171, (01)00884838099203(21)153, (01)00884838099203(21)108, (01)00884838099203(21)207, (01)00884838099203(21)208, (01)00884838099203(21)198, (01)00884838099203(21)193, (01)00884838099203(21)194, (01)00884838099203(21)205, (01)00884838099203(21)203, (01)00884838099203(21)202, (01)00884838099203(21)195, (01)00884838099203(21)196, (01)00884838099203(21)197, (01)00884838099203(21)190, (01)00884838099203(21)146, (01)00884838099203(21)186, (01)00884838099203(21)35, (01)00884838099203(21)43, (01)00884838099203(21)180, (01)00884838099203(21)187, (01)00884838099203(21)182, (01)00884838099203(21)185, (01)00884838099203(21)173, (01)00884838099203(21)183, (01)00884838099203(21)164, (01)00884838099203(21)184, (01)00884838099203(21)165, (01)00884838099203(21)176, (01)00884838099203(21)174, (01)00884838099203(21)159, (01)00884838099203(21)161, (01)00884838099203(21)157, (01)00884838099203(21)169, (01)00884838099203(21)162, (01)00884838099203(21)167, (01)00884838099203(21)168, (01)00884838099203(21)142, (01)00884838099203(21)145, (01)00884838099203(21)158, (01)00884838099203(21)166, (01)00884838099203(21)163, (01)00884838099203(21)149, (01)00884838099203(21)126, (01)00884838099203(21)154, (01)00884838099203(21)151, (01)00884838099203(21)127, (01)00884838099203(21)152, (01)00884838099203(21)155, (01)00884838099203(21)131, (01)00884838099203(21)147, (01)00884838099203(21)129, (01)00884838099203(21)122, (01)00884838099203(21)133, (01)00884838099203(21)144, (01)00884838099203(21)130, (01)00884838099203(21)143, (01)00884838099203(21)135, (01)00884838099203(21)140, (01)00884838099203(21)141, (01)00884838… (truncated, 286574 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

Fungal contamination of affected lot with Parengyodontium album.

ALL 50 STATES
Full report

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

Recall #:
98058
Lot/product code:
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

ALL 50 STATES
Full report

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

Recall #:
98091
Lot/product code:
Catalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836, 7306040, 7306041, 7306042, 7306043, 7306044, 7306045, 7306046, 7306047, 7306050, 7306051, 7306052, 7307670, 7307671, 7307672, 7325482, 7307675, 7325481, 7325483, 7325484, 7307673, 7307674, 7325485, 7325486, 7336611, 7336612, 7336614, 7336623, 7336613, 7336615, 7336616, 7336618, 7336619, 7336620, 7336621, 7336622, 7306048, 7306049, 7336626, 7336627, 7336629, 7347166, 7336628, 7346295, 7346297, 7346299, 7346301, 7365434, 7365435, 7392019, 7396607, 7396608, 7396609, 7396610, 7392034, 7392067, 7405790, 7405791, 7405792, 7405793, 7406633, 7406634, 7406636, 7406637, 7406639, 7406640, 7406641, 7406642, 7406635, 7406638, 7408813, 7408815, 7408818, 7408814, 7408816, 7468726, 7468727, 7411801, 7411802, 7414641, 7414642, 7468731, 7468732, 7468745, 7468746, 7468741, 7468742, 7468743, 7468744, 7468771, 7468769, 7468770, 7468773, 7468774, 7468775, 7482179, 7482180, 7482181, 7482182, 7482183, 7482184, 7482185, 7482186, 7468772, 7482154, 7482155, 7482156, 7482157, 7468801, 7468804, 7468805, 7468806, 7482136, 7468802, 7468803, 7482132, 7482134, 7482135, 7482137, 7482159, 7482158, 7482160, 7482161, 7495593, 7495594, 7495596, 7495597, 7495598, 7495599, 7482212, 7495600, 7495601, 7495602, 7495603, 7495604, 7495605, 7495606, 7495607, 7495608, 7495635, 7495636, 7495637, 7495638, 7495639, 7495640, 7495641, 7495642, 7495643, 7495666, 7495644, 7495664, 7482213, 7495667, 7503597, 7503598, 7503599, 7503659, 7510140, 7510141, 7510142, 7503600, 7503601, 7517716, 7517708, 7503627, 7503628, 7503630, 7503631, 7503632, 7503633, 7503629, 7503664, 7503657, 7503662, 7503663, 7503602, 7503624, 7510156, 7517703, 7517704, 7517706, 7517707, 7517709, 7517710, 7517711, 7517712, 7517714, 7517715, 7408817, 7411797, 7411798, 7411799, 7411800, 7414643, 7414644, 7414645, 7414646, 7414647, 7414648, 7414649, 7417938, 7417940, 7417942, 7417944, 7417946, 7417948, 7417950, 7417952, 7417955, 7417957, 7417959, 7503625.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

ALL 50 STATES
Full report

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

Recall #:
98158
Lot/product code:
Model No. 867216; UDI [Serial No.]: , (01)00884838099876(21)DK32800791[DK32800791], (01)00884838099876(21)DK32800825[DK32800825], (01)00884838099876(21)DK32800918[DK32800918], (01)00884838099876(21)DK32800947[DK32800947], (01)00884838099876(21)DK32801055[DK32801055], (01)00884838099876(21)DK32801076[DK32801076], (01)00884838099876(21)DK32801098[DK32801098], (01)00884838099876(21)DK32801120[DK32801120], (01)00884838099876(21)DK32801188[DK32801188], (01)00884838099876(21)DK32801197[DK32801197], (01)00884838099876(21)DK32801225[DK32801225], (01)00884838099876(21)DK32801235[DK32801235], (01)00884838099876(21)DK32801252[DK32801252], (01)00884838099876(21)DK32801306[DK32801306], (01)00884838099876(21)DK32801338[DK32801338], (01)00884838099876(21)DK33402127[DK33402127], (01)00884838099876(21)DK33402141[DK33402141], (01)00884838099876(21)DK33402210[DK33402210], (01)00884838099876(21)DK33402281[DK33402281], (01)00884838099876(21)DK33402309[DK33402309], (01)00884838099876(21)DK33402345[DK33402345], (01)00884838099876(21)DK33402358[DK33402358], (01)00884838099876(21)DK33402363[DK33402363], (01)00884838099876(21)DK33402364[DK33402364], (01)00884838099876(21)DK33402437[DK33402437], (01)00884838099876(21)DK33402526[DK33402526], (01)00884838099876(21)DK33402553[DK33402553], (01)00884838099876(21)DK33402569[DK33402569], (01)00884838099876(21)DK33402630[DK33402630], (01)00884838099876(21)DK33402653[DK33402653], (01)00884838099876(21)DK33402657[DK33402657], (01)00884838099876(21)DK33402737[DK33402737], (01)00884838099876(21)DK33402805[DK33402805], (01)00884838099876(21)DK33402894[DK33402894], (01)00884838099876(21)DK33402955[DK33402955], (01)00884838099876(21)DK33403058[DK33403058], (01)00884838099876(21)DK33403144[DK33403144], (01)00884838099876(21)DK33403145[DK33403145], (01)00884838099876(21)DK33403209[DK33403209], (01)00884838099876(21)DK33403222[DK33403222], (01)00884838099876(21)DK33403235[DK33403235], (01)00884838099876(21)DK33603488[DK33603488], (01)00884838099876(21)DK33603527[DK33603527], (01)00884838099876(21)DK33603582[DK33603582], (01)00884838099876(21)DK33603584[DK33603584], (01)00884838099876(21)DK33603673[DK33603673], (01)00884838099876(21)DK33603678[DK33603678], (01)00884838099876(21)DK33603746[DK33603746], (01)00884838099876(21)DK33603796[DK33603796], (01)00884838099876(21)DK33603971[DK33603971], (01)00884838099876(21)DK33603989[DK33603989], (01)00884838099876(21)DK33603999[DK33603999], (01)00884838099876(21)DK33604020[DK33604020], (01)00884838099876(21)DK33604046[DK33604046], (01)00884838099876(21)DK33604057[DK33604057], (01)00884838099876(21)DK33604109[DK33604109], (01)00884838099876(21)DK33604128[DK33604128], (01)00884838099876(21)DK33604162[DK33604162], (01)00884838099876(21)DK33604229[DK33604229], (01)00884838099876(21)DK33604235[DK33604235], (01)00884838099876(21)DK33604249[DK33604249], (01)00884838099876(21)DK33604252[DK33604252], (01)00884838099876(21)DK33604424[DK33604424], (01)00884838099876(21)DK33604425[DK33604425], (01)00884838099876(21)DK33604524[DK33604524], (01)00884838099876(21)DK33604571[DK33604571], (01)00884838099876(21)DK33604588[DK33604588], (01)00884838099876(21)DK33604612[DK33604612], (01)00884838099876(21)DK33904737[DK33904737], (01)00884838099876(21)DK33904802[DK33904802], (01)00884838099876(21)DK33904818[DK33904818], (01)00884838099876(21)DK33904830[DK33904830], (01)00884838099876(21)DK33904834[DK33904834], (01)00884838099876(21)DK33904949[DK33904949], (01)00884838099876(21)DK33904961[DK33904961], (01)00884838099876(21)DK33905053[DK33905053], (01)00884838099876(21)DK33905076[DK33905076], (01)00884838099876(21)DK33905149[DK33905149], (01)00884838099876(21)DK34305222[DK34305222], (01)00884838099876(21)DK34305227[DK34305227], (01)00884838099876(21)DK34305256[DK34305256], (01)00884838099876(21)DK34405461[DK34405461], (01)00884838099876(21)DK34405464[DK34405464], (01)00884838099876(21)DK34405673[DK34405673], (01)00884838099876(21)DK34405777[DK34405777], (01)00884838099876(21)DK34405778[DK34405778], (01)00884838099876(21)DK34405795[DK34405795], (01)00884838099876(21)DK34706009[DK34706009], (01)00884838099876(21)DK34706048[DK34706048], (01)00884838099876(21)DK34706100[DK34706100], (01)00884838099876(21)DK34706116[DK34706116], (01)00884838099876(21)DK34706181[DK34706181], (01)00884838099876(21)DK34706271[DK34706271], (01)00884838099876(21)DK34706308[DK34706308], (01)00884838099876(21)DK34706385[DK34706385], (01)00884838099876(21)DK34706394[DK34706394], (01)00884838099876(21)DK34706485[DK34706485], (01)00884838099876(21)DK40306620[DK40306620], (01)00884838099876(21)DK40306621[DK40306621], (01)00884838099876(21)DK40306622[DK40306622], (01)00884838099876(21)DK40306681[DK40306681], (01)00884838099876(21)DK40306690[DK40306690], (01)00884838099876(21)DK40306709[DK40306709], (01)00884838099876(21)DK40306749[DK40306749], (01)00884838099876(21)DK40306765[DK40306765], (01)00884838099876(21)DK40306766[DK40306766], (01)00884838099876(21)DK40306781[DK40306781], (01)00884838099876(21)DK40306796[DK40306… (truncated, 17700 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

ALL 50 STATES
Full report

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DT22880: UDI/DI 10653160995470 (EA) 40653160995471 (CS), Lot Number 25KMJ441; Medline Kit SKU DYNDC3283A: UDI/DI 10198459313240 (EA) 40198459313241 (CS), Lot Number 25KMH515.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

ALL 50 STATES
Full report

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

Recall #:
98226
Lot/product code:
UDI/DI 10198459565861 (EA) 40198459565862 (CS), Lot number 25KMD285
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled December 12, 2025

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0288-2026
Lot/product code:
All lots within expiry.
Recalling firm:
Medinatura New Mexico, inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenSoyUndeclaredRecalled December 12, 2025

1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6

Not listed on the label soy lecithin

Full report

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

Recall #:
H-0384-2026
Lot/product code:
Lot numbers: 22236, 23175, 24019, 24051, 25070, 25247
Recalling firm:
House Of Flavors, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K; 6) CENTRAL LINE PACK-LF, Kit SKU DYNJ0220136S; 7) SPINE PACK-LF, Kit SKU DYNJ0376635Q; 8) ORTHO SPINAL PACK-LF, Kit SKU DYNJ0460768T; 9) W.C. MINOR LAPAROTOMY PK-LF, Kit SKU DYNJ0509186J; 10) NEURO SHUNT PACK-LF, Kit SKU DYNJ0578815W; 11) ANCILLARY SPINE PACK-LF, Kit SKU DYNJ0610290T; 12) MINOR LAPAROTOMY PACK-LF, Kit SKU DYNJ0753436P; 13) KNEE SCOPE PACK-LF, Kit SKU DYNJ0890502R; 14) PEDIATRIC PACK-LF, Kit SKU DYNJ28212L; 15) ANTERIOR CERVICAL PACK, Kit SKU DYNJ31341P; 16) PEDIATRIC MINOR PROCEDURE PACK, Kit SKU DYNJ37615J; 17) LAPAROSCOPY PACK, Kit SKU DYNJ39215N; 18) MAJOR LAP VCH, Kit SKU DYNJ39217P; 19) NEURO PACK, Kit SKU DYNJ39220N; 20) CAS HAND PK, Kit SKU DYNJ39468G; 21) RFT ISC NOBLES MINOR PACK, Kit SKU DYNJ43954B; 22) PED OPEN HEART PACK, Kit SKU DYNJ45373G; 23) MAJOR GENERAL PACK-LF, Kit SKU DYNJ51436F; 24) MINOR PK-LF, Kit SKU DYNJ51437C; 25) VEIN ABLATION & EXCISION ASC, Kit SKU DYNJ52586C; 26) SHOULDER PACK, Kit SKU DYNJ56889B; 27) LAP CHOLE PACK, Kit SKU DYNJ57206F; 28) TRANSGENDER MASTECTOMY 2, Kit SKU DYNJ58257I; 29) SHOULDER ARTH PACK, Kit SKU DYNJ58410D; 30) MAJOR PACK, Kit SKU DYNJ58528J; 31) PACK BREAST, Kit SKU DYNJ60157F; 32) CH TRANSPHENOIDAL PACK, Kit SKU DYNJ61696I; 33) RR-SPINE PACK, Kit SKU DYNJ62643B; 34) MINOR PACK, Kit SKU DYNJ64238D; 35) PBMS NECK PACK-LF, Kit SKU DYNJ64961C; 36) BREAST PACK, Kit SKU DYNJ64988C; 37) MINOR PACK 180110, Kit SKU DYNJ65447C; 38) PACK,V-P SHUNT, Kit SKU DYNJ65472C; 39) BASIC PACK, Kit SKU DYNJ65996D; 40) MINOR SS, Kit SKU DYNJ66094A; 41) CRMC ROBOTIC GENERAL PACK, Kit SKU DYNJ66613D; 42) PEDIATRIC GENERAL PACK, Kit SKU DYNJ66644F; 43) URO/GYN PACK, Kit SKU DYNJ66675F; 44) SHOULDER SCOPE PACK, Kit SKU DYNJ68707B; 45) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844B; 46) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844C; 47) ACF PACK, Kit SKU DYNJ69112C; 48) SM OR-DR. YEH PACK-LF, Kit SKU DYNJ69705C; 49) SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ81752C; 50) C BIRTH SET UP PACK, Kit SKU DYNJ81994C; 51) TRIAL PACK, Kit SKU DYNJ82770A; 52) PROSTATE ROBOTIC PACK, Kit SKU DYNJ84120C; 53) HAND PACK, Kit SKU DYNJ85033A; 54) ARTHROSCOPY PACK, Kit SKU DYNJ85197A; 55) GU-GYN-LITHO PACK, Kit SKU DYNJ86013A; 56) DBD-ARTHROSCOPY PACK, Kit SKU DYNJ86963A; 57) BREAST PACK, Kit SKU DYNJ87587A; 58) PACK,PEDIATRIC MINOR, Kit SKU DYNJ88718; 59) UNIVERSAL-ASC, Kit SKU DYNJ900071C; 60) BASIC, Kit SKU DYNJ905869G; 61) PACK,PEDIATRIC MAJOR, Kit SKU DYNJ906888F; 62) HAND/FOOT PACK, Kit SKU DYNJT3131A; 63) SHOULDER PACK, Kit SKU DYNJT3266; 64) LUMBAR PACK, Kit SKU DYNJT4178; 65) CVS ICU PACK, Kit SKU PHS41728D; 66) SINGLE TAP BLOCK TRAY, Kit SKU SPEC0156A.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

ALL 50 STATES
Full report

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

Recall #:
98226
Lot/product code:
Medline Kit SKU ACC010270A: UDI/DI 10889942219827 (EA) 40889942219828 (CS), Lot Number 25LDA153; Medline Kit SKU ACC010690: UDI/DI 10195327433307 (EA) 40195327433308 (CS), Lot Number 25LDA088; Medline Kit SKU ACC011073: UDI/DI 10198459569333 (EA) 40198459569334 (CS), Lot Number 25LDA072; Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25KMC904; Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25LMA071; Medline Kit SKU DYNJ0101360K: UDI/DI 10195327662066 (EA) 40195327662067 (CS), Lot Number 25KMC709; Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25KMB403; Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25JMF503; Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMH121; Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMF780; Medline Kit SKU DYNJ0460768T: UDI/DI 10198459466809 (EA) 40198459466800 (CS), Lot Number 25KMH789; Medline Kit SKU DYNJ0509186J: UDI/DI 10198459117626 (EA) 40198459117627 (CS), Lot Number 25KME895; Medline Kit SKU DYNJ0578815W: UDI/DI 10198459466892 (EA) 40198459466893 (CS), Lot Number 25JMJ695; Medline Kit SKU DYNJ0610290T: UDI/DI 10198459021558 (EA) 40198459021559 (CS), Lot Number 25KMC723; Medline Kit SKU DYNJ0753436P: UDI/DI 10198459466854 (EA) 40198459466855 (CS), Lot Number 25KMJ740; Medline Kit SKU DYNJ0890502R: UDI/DI 10198459431098 (EA) 40198459431099 (CS), Lot Number 25KME522; Medline Kit SKU DYNJ28212L: UDI/DI 10193489322118 (EA) 40193489322119 (CS), Lot Number 25KBE916; Medline Kit SKU DYNJ31341P: UDI/DI 10198459069352 (EA) 40198459069353 (CS), Lot Number 25KMA795; Medline Kit SKU DYNJ37615J: UDI/DI 10195327560881 (EA) 40195327560882 (CS), Lot Number 25KDB706; Medline Kit SKU DYNJ39215N: UDI/DI 10198459102240 (EA) 40198459102241 (CS), Lot Number 25KMH027; Medline Kit SKU DYNJ39217P: UDI/DI 10198459102356 (EA) 40198459102357 (CS), Lot Number 25LMA409; Medline Kit SKU DYNJ39220N: UDI/DI 10198459102387 (EA) 40198459102388 (CS), Lot Number 25KMJ608; Medline Kit SKU DYNJ39468G: UDI/DI 10198459408595 (EA) 40198459408596 (CS), Lot Number 25KMD121; Medline Kit SKU DYNJ43954B: UDI/DI 10193489509168 (EA) 40193489509169 (CS), Lot Number 25KMD726; Medline Kit SKU DYNJ45373G: UDI/DI 10198459254635 (EA) 40198459254636 (CS), Lot Number 25JMH775; Medline Kit SKU DYNJ51436F: UDI/DI 10198459004315 (EA) 40198459004316 (CS), Lot Number 25KMG978; Medline Kit SKU DYNJ51437C: UDI/DI 10198459005114 (EA) 40198459005115 (CS), Lot Number 25JMJ673; Medline Kit SKU DYNJ52586C: UDI/DI 10195327596521 (EA) 40195327596522 (CS), Lot Number 25KMH637; Medline Kit SKU DYNJ56889B: UDI/DI 10198459490088 (EA) 40198459490089 (CS), Lot Number 25KBE707; Medline Kit SKU DYNJ57206F: UDI/DI 10195327682958 (EA) 40195327682959 (CS), Lot Number 25KMG080; Medline Kit SKU DYNJ58257I: UDI/DI 10198459565526 (EA) 40198459565527 (CS), Lot Number 25LMA492; Medline Kit SKU DYNJ58410D: UDI/DI 10198459366468 (EA) 40198459366469 (CS), Lot Number 25KBF113; Medline Kit SKU DYNJ58528J: UDI/DI 10198459322815 (EA) 40198459322816 (CS), Lot Number 25JBW494; Medline Kit SKU DYNJ60157F: UDI/DI 10198459343445 (EA) 40198459343446 (CS), Lot Number 25KMI064; Medline Kit SKU DYNJ61696I: UDI/DI 10198459208713 (EA) 40198459208714 (CS), Lot Number 25KMF819; Medline Kit SKU DYNJ62643B: UDI/DI 10198459164446 (EA) 40198459164447 (CS), Lot Number 25KMB841; Medline Kit SKU DYNJ64238D: UDI/DI 10198459068447 (EA) 40198459068448 (CS), Lot Number 25KME422; Medline Kit SKU DYNJ64961C: UDI/DI 10198459569777 (EA) 40198459569778 (CS), Lot Number 25KMD570; Medline Kit SKU DYNJ64988C: UDI/DI 10198459373008 (EA) 40198459373009 (CS), Lot Number 25LMB275; Medline Kit SKU DYNJ65447C: UDI/DI 10198459605222 (EA) 40198459605223 (CS), Lot Number 25LMA822; Medline Kit SKU DYNJ65472C: UDI/DI 10198459168727 (EA) 40198459168728 (CS), Lot Number 25KMD067; Medline Kit SKU DYNJ65996D: UDI/DI 10198459376726 (EA) 40198459376727 (CS), Lot Number 25KMJ550; Medline Kit SKU DYNJ66094A: UDI/DI 10198459462689 (EA) 40198459462680 (CS), Lot Number 25LMB276; Medline Kit SKU DYNJ66613D: UDI/DI 10198459504488 (EA) 40198459504489 (CS), Lot Number 25KMI271; Medline Kit SKU DYNJ66644F: UDI/DI 10198459574160 (EA) 40198459574161 (CS), Lot Number 25KMD640; Medline Kit SKU DYNJ66675F: UDI/DI 10198459574108 (EA) 40198459574109 (CS), Lot Number 25LMA853; Medline Kit SKU DYNJ68707B: UDI/DI 10198459001734 (EA) 40198459001735 (CS), Lot Number 25KBE843; Medline Kit SKU DYNJ68844B: UDI/DI 10198459232428 (EA) 40198459232429 (CS), Lot Number 25KMF829; Medline Kit SKU DYNJ68844C: UDI/DI 10198459608360 (EA) 40198459608361 (CS), Lot Number 25LMA922; Medline Kit SKU DYNJ69112C: UDI/DI 10198459176128 (EA) 40198459176129 (CS), Lot Number 25KME071; Medline Kit SKU DYNJ69705C: U… (truncated, 6847 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 December 12, 2025

Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

ALL 50 STATES
Full report

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25LMA655; Medline Kit SKU DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25KMC911.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G -Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G -Amyloid 1-42-N Plasma IRC), for the quantitative measurement of -Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): 3 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti--amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti--amyloid 1-42 monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

ALL 50 STATES
Full report

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

Recall #:
98232
Lot/product code:
Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;
Recalling firm:
Fujirebio Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse -Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing -amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse -Amyloid Plasma Controls: Liquid (Frozen), 2 2 Concentrations L1 Level 1 (2 1.5 mL) L2 Level 2 (2 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

ALL 50 STATES
Full report

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

Recall #:
98232
Lot/product code:
Model/Catalog Number: 81559; UDI-DI: 05414470815593; Lot Number: T8B6116U;
Recalling firm:
Fujirebio Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse pTau 217 Plasma Controls: Liquid (Frozen), 2 2 Concentrations L1 Level 1 (2 1.5 mL) L2 Level 2 (2 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

ALL 50 STATES
Full report

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

Recall #:
98232
Lot/product code:
Model/Catalog Number: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;
Recalling firm:
Fujirebio Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

ALL 50 STATES
Full report

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

Recall #:
98232
Lot/product code:
Model/Catalog Number: 81557; UDI-DI: 05414470815579; Lot Numbers: D5C6094U, D5C6125U;
Recalling firm:
Fujirebio Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G -Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse -Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G -Amyloid 1-42-N Plasma Calibrators set 235454 Component: No

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

ALL 50 STATES
Full report

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

Recall #:
98232
Lot/product code:
Model/Catalog Number: CL0073; UDI-DI: 00869164000086; Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio ("Ratio") is related to the "Ratio" Instructions for Use (IFU). Therefore, each consignee has 1 "Ratio" in which they purchase the component kits for.
Recalling firm:
Fujirebio Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators: The -Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G -Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 1.5 mL (4 Concentrations) CAL 1 0 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL -Amyloid 1-42-N Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950. Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

ALL 50 STATES
Full report

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

Recall #:
98232
Lot/product code:
Model/Catalog Number: 235454; UDI-DI: 04987270235454; Lot Numbers: D8C6022U, D8C6044U;
Recalling firm:
Fujirebio Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

NexxZr T Multi A3.5 W98-16mm, REF: 745451

Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.

ALL 50 STATES
Full report

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

Recall #:
98823
Lot/product code:
UDI-DI: 00842271175373, Lot: YBDGLD
Recalling firm:
Sagemax Bioceramics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Potential for microbial contamination.

ALL 50 STATES
Full report

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

Recall #:
98166
Lot/product code:
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2025

Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

ALL 50 STATES
Full report

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

Recall #:
98232
Lot/product code:
Model/Catalog Number: 81550; UDI-DI: 05414470815500; Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U;
Recalling firm:
Fujirebio Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2025

Mazor X robotic guidance system REF: TPL0059

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

ALL 50 STATES
Full report

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

Recall #:
98199
Lot/product code:
Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
Recalling firm:
Mazor Robotics Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2025

Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

Some of the Calibration/Output Certificates had the outputs reversed.

ALL 50 STATES
Full report

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

Recall #:
98817
Lot/product code:
Serial Numbers: 2-03409NB4DT 2-03560NB4DT 2-03798NB4DT 2-03472NB4DT 2-03315NB4DT 2-03726NB4DT 2-03396NB4DT 2-03320NB4DT 2-03447NB4DT 2-03564NB4DT 2-03516NB4DT 2-03467NB4DT 2-03292NB4DT 2-03371NB4DT 2-03433NB4DT 2-03446NB4DT 2-03343NB4DT 2-03400NB4DT 2-03342NB4DT 2-03547NB4DT 2-03449NB4DT 2-03685NB4DT 2-03574NB4DT 2-03392NB4DT 2-03345NB4DT 2-03431NB4DT 2-03608NB4DT 2-03530NB4DT 2-03501NB4DT 2-03362NB4DT 2-03603NB4DT 2-03713NB4DT 2-03508NB4DT 2-03341NB4DT 2-03418NB4DT 2-03721NB4DT 2-03662NB4DT 2-03679NB4DT 2-03591NB4DT 2-03319NB4DT 2-03411NB4DT 2-03505NB4DT 2-03335NB4DT 2-03585NB4DT 2-03556NB4DT 2-03355NB4DT 2-03664NB4DT 2-03515NB4DT 2-03424NB4DT 2-03470NB4DT 2-03386NB4DT 2-03455NB4DT 2-03401NB4DT 2-03391NB4DT 2-03578NB4DT 2-03388NB4DT 2-03632NB4DT 2-03615NB4DT 2-03434NB4DT 2-03454NB4DT 2-03387NB4DT 2-03390NB4DT 2-03569NB4DT 2-03541NB4DT 2-03509NB4DT 2-03789NB4DT 2-03804NB4DT 2-03439NB4DT 2-03367NB4DT 2-03442NB4DT 2-03750NB4DT 2-03349NB4DT 2-03510NB4DT 2-03538NB4DT 2-03559NB4DT 2-03539NB4DT 2-03491NB4DT 2-03502NB4DT 2-03629NB4DT 2-03383NB4DT 2-03496NB4DT 2-03619NB4DT 2-03511NB4DT 2-03670NB4DT 2-03565NB4DT 2-03581NB4DT 2-03479NB4DT 2-03348NB4DT 2-03534NB4DT 2-03484NB4DT 2-03802NB4DT 2-03504NB4DT 2-03457NB4DT 2-03417NB4DT 2-03482NB4DT 2-03318NB4DT 2-03503NB4DT 2-03518NB4DT 2-03350NB4DT 2-03686NB4DT 2-03317NB4DT 2-03687NB4DT 2-03507NB4DT 2-03663NB4DT 2-03658NB4DT 2-03330NB4DT 2-03489NB4DT 2-03451NB4DT 2-03486NB4DT 2-03465NB4DT 2-03346NB4DT 2-03598NB4DT 2-03377NB4DT 2-03414NB4DT 2-03422NB4DT 2-03531NB4DT 2-03329NB4DT 2-03579NB4DT 2-03817NB4DT 2-03613NB4DT 2-03322NB4DT 2-03570NB4DT 2-03397NB4DT 2-03326NB4DT 2-03347NB4DT 2-03469NB4DT 2-03483NB4DT 2-03359NB4DT 2-03344NB4DT 2-03436NB4DT 2-03711NB4DT 2-03437NB4DT 2-03459NB4DT 2-03384NB4DT 2-03389NB4DT 2-03592NB4DT 2-03432NB4DT 2-03823NB4DT 2-03616NB4DT 2-03498NB4DT 2-03512NB4DT 2-03809NB4DT 2-03647NB4DT 2-03606NB4DT 2-03722NB4DT 2-03818NB4DT 2-03589NB4DT 2-03356NB4DT 2-03583NB4DT 2-03799NB4DT 2-03487NB4DT 2-03398NB4DT 2-03775NB4DT 2-03427NB4DT 2-03533NB4DT 2-03676NB4DT 2-03468NB4DT 2-03684NB4DT 2-03413NB4DT 2-03716NB4DT 2-03374NB4DT 2-03430NB4DT 2-03473NB4DT 2-03575NB4DT 2-03339NB4DT 2-03666NB4DT 2-03323NB4DT 2-03471NB4DT 2-03334NB4DT 2-03310NB4DT 2-03631NB4DT 2-03405NB4DT 2-03720NB4DT 2-03372NB4DT 2-03463NB4DT 2-03353NB4DT 2-03563NB4DT 2-03419NB4DT 2-03725NB4DT 2-03621NB4DT 2-03336NB4DT 2-03312NB4DT 2-03806NB4DT 2-03572NB4DT 2-03597NB4DT 2-03370NB4DT 2-03435NB4DT 2-03354NB4DT 2-03555NB4DT 2-03440NB4DT 2-03376NB4DT 2-03610NB4DT 2-03653NB4DT 2-03749NB4DT 2-03380NB4DT 2-03558NB4DT 2-03462NB4DT 2-03313NB4DT 2-03517NB4DT 2-03790NB4DT 2-03513NB4DT 2-03602NB4DT 2-03683NB4DT 2-03561NB4DT 2-03514NB4DT 2-03604NB4DT 2-03445NB4DT 2-03423NB4DT 2-03338NB4DT 2-03375NB4DT 2-03361NB4DT 2-03543NB4DT 2-03492NB4DT 2-03801NB4DT 2-03497NB4DT 2-03601NB4DT 2-03824NB4DT 2-03477NB4DT 2-03545NB4DT 2-03813NB4DT 2-03557NB4DT 2-03426NB4DT 2-03428NB4DT 2-03394NB4DT 2-03645NB4DT 2-03842NB4DT 2-03528NB4DT 2-03321NB4DT 2-03478NB4DT 2-03438NB4DT 2-03369NB4DT 2-03661NB4DT 2-03682NB4DT 2-03412NB4DT 2-03351NB4DT 2-03673NB4DT 2-03453NB4DT 2-03605NB4DT 2-03461NB4DT 2-03495NB4DT 2-03582NB4DT 2-03540NB4DT 2-03594NB4DT 2-03612NB4DT 2-03810NB4DT 2-03364NB4DT 2-03609NB4DT 2-03672NB4DT 2-03529NB4DT 2-03379NB4DT 2-03554NB4DT 2-03490NB4DT 2-03407NB4DT 2-03586NB4DT 2-03600NB4DT 2-03618NB4DT 2-03421NB4DT 2-03659NB4DT 2-03671NB4DT 2-03448NB4DT 2-03607NB4DT 2-03402NB4DT 2-03485NB4DT 2-03480NB4DT 2-03420NB4DT 2-03328NB4DT 2-03408NB4DT 2-03481NB4DT 2-03625NB4DT 2-03331NB4DT 2-03614NB4DT 2-03646NB4DT 2-03668NB4DT 2-03800NB4DT 2-03499NB4DT 2-03753NB4DT 2-03520NB4DT 2-03464NB4DT 2-03316NB4DT 2-03580NB4DT 2-03675NB4DT 2-03665NB4DT 2-03546NB4DT 2-03590NB4DT 2-03544NB4DT 2-03415NB4DT 2-03719NB4DT 2-03456NB4DT 2-03532NB4DT 2-03385NB4DT 2-03452NB4DT 2-03593NB4DT 2-03366NB4DT 2-03759NB4DT 2-03506NB4DT 2-03425NB4DT 2-03660NB4DT 2-03360NB4DT 2-03519NB4DT 2-03688NB4DT 2-03537NB4DT 2-03429NB4DT 2-03406NB4DT 2-03340NB4DT 2-03311NB4DT 2-03562NB4DT 2-03474NB4DT 2-03655NB4DT 2-03466NB4DT 2-03595NB4DT 2-03476NB4DT 2-03403NB4DT 2-03752NB4DT 2-03332NB4DT 2-03314NB4DT 2-03309NB4DT 2-03678NB4DT 2-03410NB4DT 2-03460NB4DT 2-03717NB4DT 2-03521NB4DT 2-03674NB4DT 2-03363NB4DT 2-03667NB4DT 2-03475NB4DT 2-03724NB4DT 2-03493NB4DT 2-03617NB4DT 2-03680NB4DT 2-03494NB4DT 2-03450NB4DT 2-03754NB4DT 2-03378NB4DT 2-03712NB4DT 2-03840NB4DT 2-03441NB4DT 2-03416NB4DT 2-03393NB4DT 2-03577NB4DT 2-03751NB4DT 2-03681NB4DT 2-03368NB4DT 2-03333NB4DT 2-03640NB4DT 2-03373NB4DT 2-03358NB4DT 2-03500NB4DT 2-03596NB4DT 2-03811NB4DT 2-03308NB4DT 2-03669NB4DT 2-03337NB4DT 2-03381NB4DT 2-03352NB4DT 2-03488NB4DT 2-03382NB4DT 2-03443NB4DT 2-03357NB4DT 2-03444NB4DT 2-03542NB4DT 2-03599NB4DT 2-03404NB4DT 2-03395NB4DT 2-03365NB4DT 2-03399NB4DT 2-03576NB4DT 2-03458NB4DT 2-03611NB4DT
Recalling firm:
Daavlin Distributing Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2025

MAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.

ALL 50 STATES
Full report

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

Recall #:
98260
Lot/product code:
PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Recalling firm:
REPLIGEN CORPORATION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2025

SMV DSX New Line, System, Tomography, Computed, Emission

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

ALL 50 STATES
Full report

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

Recall #:
98133
Lot/product code:
UDI/DI Not applicable: All serial numbers in distribution
Recalling firm:
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2025

SMV BodyTrack, System, Tomography, Computed, Emission

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

ALL 50 STATES
Full report

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

Recall #:
98133
Lot/product code:
UDI/DI Not applicable: All serial numbers in distribution
Recalling firm:
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2025

SMV DSI, System, Tomography, Computed, Emission

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

ALL 50 STATES
Full report

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

Recall #:
98133
Lot/product code:
UDI/DI Not applicable: All serial numbers in distribution
Recalling firm:
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
View official FDA record (opens in a new tab)