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Recalls affecting New York

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

17,416 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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 Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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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 Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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Food & Beverages

Recalling firm: American Regent, Inc.

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

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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 Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

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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

Martina — Mangoes

Potential contamination with Salmonella

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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

Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.

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.

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▸Full report

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ0660040R: UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Number 25KMG652; Medline Kit SKU DYNJ39225K: UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25JMJ958; Medline Kit SKU DYNJ39225K: UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25KMJ566; Medline Kit SKU DYNJ46620I: UDI/DI 10198459404009 (EA) 40198459404000 (CS), Lot Number 25KBE927; Medline Kit SKU DYNJ59250I: UDI/DI 10198459359941 (EA) 40198459359942 (CS), Lot Number 25KMB767; Medline Kit SKU DYNJ65980J: UDI/DI 10198459423727 (EA) 40198459423728 (CS), Lot Number 25KMJ630; Medline Kit SKU DYNJ68288A: UDI/DI 10195327056995 (EA) 40195327056996 (CS), Lot Number 25KMF183; Medline Kit SKU MNS13035: UDI/DI 10653160990482 (EA) 40653160990483 (CS), Lot Number 25KME754; Medline Kit SKU PHS41746D: UDI/DI 10198459438820 (EA) 40198459438821 (CS), Lot Number 25KMD226.
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)
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.

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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, 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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

Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B; 7) MINOR SET UP PACK, Kit SKU DYNJ43272K; 8) PK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C; 9) GV LAP CHOLE PACK, Kit SKU DYNJ46939Q; 10) LAP CHOLE PACK, Kit SKU DYNJ49688C; 11) GENERAL ROBOTIC LAP, Kit SKU DYNJ51347N; 12) LAP CHOLE PACK, Kit SKU DYNJ54081F; 13) PEDIATRIC MOSES, Kit SKU DYNJ58864B; 14) LAPAROTOMY PACK, Kit SKU DYNJ59313B; 15) CRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F; 16) LAP GASTRIC PACK, Kit SKU DYNJ62065A; 17) MINOR PACK, Kit SKU DYNJ64174A; 18) GENERAL SURGERY PACK, Kit SKU DYNJ64258I; 19) GENERAL LAP SHARED-LF, Kit SKU DYNJ64786D; 20) CHOLE PACK, Kit SKU DYNJ67686B; 21) GEN SURG MINOR PACK, Kit SKU DYNJ69142F; 22) LAP CHOLE PACK, Kit SKU DYNJ81695B; 23) GENERAL LAPAROSCOPY, Kit SKU DYNJ900901K; 24) GEN MINOR, Kit SKU DYNJ900906L; 25) ROBOTIC GENERAL, Kit SKU DYNJ906861D; 26) RMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C; 27) LAP CHOLE LMC CDS, Kit SKU DYNJ911116A; 28) MINOR GENERAL PACK, Kit SKU DYNJT3884; 29) GENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504; 30) MINOR SURGERY PACK-LF, Kit SKU PHS109062D.

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 DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB830; Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB831; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMG395; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMH132; Medline Kit SKU DYNJ20468J: UDI/DI 10195327024338 (EA) 40195327024339 (CS), Lot Number 25KMF540; Medline Kit SKU DYNJ25763N: UDI/DI 10198459138218 (EA) 40198459138219 (CS), Lot Number 25KMH134; Medline Kit SKU DYNJ25763O: UDI/DI 10198459603655 (EA) 40198459603656 (CS), Lot Number 25KMI209; Medline Kit SKU DYNJ32836B: UDI/DI 10195327037369 (EA) 40195327037360 (CS), Lot Number 25KBF167; Medline Kit SKU DYNJ43272K: UDI/DI 10198459257131 (EA) 40198459257132 (CS), Lot Number 25KME892; Medline Kit SKU DYNJ43976C: UDI/DI 10193489806694 (EA) 40193489806695 (CS), Lot Number 25KMG962; Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25JDA437; Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25LDA059; Medline Kit SKU DYNJ49688C: UDI/DI 10198459155017 (EA) 40198459155018 (CS), Lot Number 25KMG180; Medline Kit SKU DYNJ51347N: UDI/DI 10198459386428 (EA) 40198459386429 (CS), Lot Number 25JBW506; Medline Kit SKU DYNJ54081F: UDI/DI 10198459172410 (EA) 40198459172411 (CS), Lot Number 25KMB295; Medline Kit SKU DYNJ58864B: UDI/DI 10198459346965 (EA) 40198459346966 (CS), Lot Number 25JBW678; Medline Kit SKU DYNJ59313B: UDI/DI 10195327248338 (EA) 40195327248339 (CS), Lot Number 25JMJ736; Medline Kit SKU DYNJ61095F: UDI/DI 10198459228568 (EA) 40198459228569 (CS), Lot Number 25KMC402; Medline Kit SKU DYNJ62065A: UDI/DI 10193489273472 (EA) 40193489273473 (CS), Lot Number 25KMI773; Medline Kit SKU DYNJ64174A: UDI/DI 10198459076367 (EA) 40198459076368 (CS), Lot Number 25LMB281; Medline Kit SKU DYNJ64258I: UDI/DI 10198459031564 (EA) 40198459031565 (CS), Lot Number 25KMJ665; Medline Kit SKU DYNJ64786D: UDI/DI 10198459328671 (EA) 40198459328672 (CS), Lot Number 25JMJ978; Medline Kit SKU DYNJ67686B: UDI/DI 10198459383120 (EA) 40198459383121 (CS), Lot Number 25KMH683; Medline Kit SKU DYNJ69142F: UDI/DI 10198459478499 (EA) 40198459478490 (CS), Lot Number 25KMH891; Medline Kit SKU DYNJ81695B: UDI/DI 10198459023453 (EA) 40198459023454 (CS), Lot Number 25KMB850; Medline Kit SKU DYNJ900901K: UDI/DI 10198459272493 (EA) 40198459272494 (CS), Lot Number 25KBP907; Medline Kit SKU DYNJ900906L: UDI/DI 10198459408526 (EA) 40198459408527 (CS), Lot Number 25LMA386; Medline Kit SKU DYNJ906861D: UDI/DI 10198459293702 (EA) 40198459293703 (CS), Lot Number 25LMA703; Medline Kit SKU DYNJ907087C: UDI/DI 10198459201301 (EA) 40198459201302 (CS), Lot Number 25KMJ480; Medline Kit SKU DYNJ911116A: UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMH214; Medline Kit SKU DYNJ911116A: UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMJ766; Medline Kit SKU DYNJT3884: UDI/DI 10198459366840 (EA) 40198459366841 (CS), Lot Number 25JBX326; Medline Kit SKU DYNJT4504: UDI/DI 10198459456701 (EA) 40198459456702 (CS), Lot Number 25KMF188; Medline Kit SKU PHS109062D: UDI/DI 10889942716548 (EA) 40889942716549 (CS), Lot Number 25KMD005.
Recalling firm:
Medline Industries, LP
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

Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;

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 DYNJ64837C: UDI/DI 10198459139482 (EA) 40198459139483 (CS), Lot Number 25KMJ193; Medline Kit SKU DYNJT7034: UDI/DI 10198459592591 (EA) 40198459592592 (CS), Lot Number 25KMI766;.
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: 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.

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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: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.

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.

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▸Full report

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ0972604A: UDI/DI 10889942403905 (EA) 40889942403906 (CS), Lot Number 25KMD144; Medline Kit SKU DYNJ33822L: UDI/DI 10198459385582 (EA) 40198459385583 (CS), Lot Number 25KMD419; Medline Kit SKU DYNJ45640B: UDI/DI 10193489494983 (EA) 40193489494984 (CS), Lot Number 25KMD793; Medline Kit SKU DYNJ63377D: UDI/DI 10198459514579 (EA) 40198459514570 (CS), Lot Number 25KMI988; Medline Kit SKU DYNJ65011D: UDI/DI 10198459017018 (EA) 40198459017019 (CS), Lot Number 25KMH161; Medline Kit SKU DYNJ69143C: UDI/DI 10198459478505 (EA) 40198459478506 (CS), Lot Number 25LMB211; Medline Kit SKU DYNJ69313: UDI/DI 10193489931822 (EA) 40193489931823 (CS), Lot Number 25KMJ489; Medline Kit SKU DYNJ86007B: UDI/DI 10198459260452 (EA) 40198459260453 (CS), Lot Number 25KDB551.
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: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.

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.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU CDS984853L: UDI/DI 10198459293535 (EA) 40198459293536 (CS), Lot Number 25KMI898; Medline Kit SKU DYNJ45641B: UDI/DI 10193489494921 (EA) 40193489494922 (CS), Lot Number 25KMH748; Medline Kit SKU DYNJT3658A: UDI/DI 10198459354007 (EA) 40198459354008 (CS), Lot Number 25KME009.
Recalling firm:
Medline Industries, LP
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.

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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) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.

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 DYNJ35494C: UDI/DI 10198459117879 (EA) 40198459117870 (CS), Lot Number 25KMD420; Medline Kit SKU DYNJ38582O: UDI/DI 10198459603709 (EA) 40198459603700 (CS), Lot Number 25KMI679; Medline Kit SKU DYNJ82084F: UDI/DI 10198459089206 (EA) 40198459089207 (CS), Lot Number 25KMD145.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR 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.

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

Recall #:
98091
Lot/product code:
Catalog Number: 626631US. UDI-DI: 10381780514473. Lot Numbers: 7288007, 7288040, 7294017, 7305988, 7305989, 7305990, 7305991, 7307683, 7325489, 7336088, 7336089, 7336090, 7305992, 7346223, 7391752, 7391751, 7406650, 7406651, 7406652, 7408825, 7408826, 7408827, 7456174, 7456175, 7456176, 7456179, 7478039, 7478040, 7480073, 7480072, 7482162, 7503704, 7507495, 7503608, 7510153, 7510155, 7510154, 7534856, 7535008, 7535009, 7411809.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
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

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

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.

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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 -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 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 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 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 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).

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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.
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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.

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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.
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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.

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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
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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.

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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
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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.

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▸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

MAXXUS, 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)