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Recalls affecting Virginia

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

17,065 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

View FDA’s announcement (opens in a new tab)
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

View FDA’s announcement (opens in a new tab)
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.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

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 16, 2025

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

ALL 50 STATES
▸Full report

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

Recall #:
98197
Lot/product code:
REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870; REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25EBD110; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25DBG393; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25EBD631; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25DBM322; REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS), Lot Number 25DBT807; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25DMG099; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25CMJ006; REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS), Lot Number 25FDB347; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25EBK539; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25DBD145; REF DYNJ63392D: UDI/DI 10198459164507 (EA) 40198459164508 (CS), Lot Number 25BLA967; REF DYNJ68187B: UDI/DI 10198459382086 (EA) 40198459382087 (CS), Lot Number 25FMG440; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25EMH020; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25CMF917; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25FBK331; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25EBR783; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBP320; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBC981; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25DBA834; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25CBM884; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25FBK123; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25EBF929; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25CBT135; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25FMC215; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMF199; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMC621; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25FBO994; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25EBE439; REF DYNJ901847M: UDI/DI 10198459037863 (EA) 40198459037864 (CS), Lot Number 25BBM364; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25FBJ408; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25EBJ877; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBO236; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBC133; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMH506; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMD329; REF DYNJ905147B: UDI/DI 10193489569032 (EA) 40193489569033 (CS), Lot Number 25GDB060; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25DMK337; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25CMF465; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25EBG945; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25CBM218; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25EMD118; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25DMJ823; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMJ265; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC374; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC546; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25EBI860; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25DBR934; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25CBF096; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBJ655; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBE873; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25EBB258; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25DBR935; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25DMH137; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25CMJ730; REF DYNJ907405C… (truncated, 6391 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 16, 2025

Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
25GA Backflush Pouch UDI 810123480470 Box UDI 810123480753 Lot 2411017; 27GA Backflush Retractable Pouch UDI 810123480517 Box UDI 810123480791 Lot 2411016
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022; 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009 2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051 3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006 4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059 5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011 6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003 7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060 8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054 9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037 10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032 11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039 12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041 13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018 14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040 15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

25GA Subretinal Injection Cannula VS0220.25

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Rumex Disposable Diamond Dusted ILM Elevator, 12-7523

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 5060720920298 Box UDI 5060720920298 Lot 2411033
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. 23GA Laser Probe Curved Pouch UDI 810123480036 Box UDI 810123480180 Lot 2411027 2. 25GA Laser Probe Curved Pouch UDI 810123480043 Box UDI 810123480197 Lot 2411026 3. 25GA Laser Probe Flex-Tip Pouch UDI 810123480111 Box UDI 810123480265 Lot 2411024 2411031 4. 25GA Laser Probe Illuminated Curved Pouch UDI 810123480098 Box UDI 810123480241 Lot 2411025 5. 25GA Laser Probe MaxReach Pouch UDI 810123480135 Box UDI 810123480289 Lot 2410029 2411023 6. 25GA Laser Probe Straight Pouch UDI 810123480012 Box UDI 810123480166 Lot 2411030
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020 2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

ALL 50 STATES
▸Full report

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

Recall #:
98197
Lot/product code:
UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Surgical I2 Injection Kit, VS0500

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

Xxx

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R
Recalling firm:
Vortex Surgical Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF, REF CDS984016B; 7) LAP CHOLE KIT, REF CDS984020P; 8) LAP CHOLE-LF, REF CDS984175J; 9) LAP COLON CDS, REF CDS984849N; 10) GENERAL LAPAROSCOPY CDS, REF CDS985328M; 11) LAP CHOLE, REF DYNJQ9044O; 12) GENERAL LAPAROSCOPY V, REF DYNJS2032F; 13) LAP CHOLE PACK, REF DYNJ26209R; 14) LAP CHOLE PACK, REF DYNJ26209S; 15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D; 16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G; 17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G; 18) LAP CHOLE PACK, REF DYNJ51785D; 19) LAPAROSCOPY PACK, REF DYNJ61652A; 20) ENDOSCOPY, REF DYNJ62133A; 21) LAP CHOLE PACK, REF DYNJ66285A; 22) LAPAROSCOPY PACK, REF DYNJ66289B; 23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D; 24) LAPAROSCOPY PACK, REF DYNJ68187A; 25) LAP OB PACK, REF DYNJ68741A; 26) LAP CHOLE PACK-LF, REF DYNJ81408A; 27) LAP CHOLE PACK-LF, REF DYNJ81408B; 28) LAP CHOLE PACK, REF DYNJ85318; 29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677; 30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J; 31) LAP CHOLE, REF DYNJ901126G; 32) BARIATRIC KIT, REF DYNJ901145I; 33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M; 34) LAP GASTRIC SLEEVE, REF DYNJ901504L; 35) GENERAL LAP GASTRIC, REF DYNJ901827X; 36) GENERAL LAPAROSCOPY, REF DYNJ901847N; 37) LOU LAP SIGMOID COLON, REF DYNJ901848L; 38) LAP CHOLE, REF DYNJ901870J; 39) LEX BARIATRIC, REF DYNJ902033L; 40) BARIATRIC, REF DYNJ902515K; 41) LAP CHOLE CDS, REF DYNJ902565K; 42) LAP CHOLE, REF DYNJ902995I; 43) LAP CHOLE, REF DYNJ903163L; 44) LAP APPY, REF DYNJ903164L; 45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C; 46) LAP CHOLE, REF DYNJ904693D; 47) BARIATRIC, REF DYNJ904891N; 48) LAPAROSCOPY, REF DYNJ905071F; 49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F; 50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G; 51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D; 52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A; 53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B; 54) LAP BARIATRIC, REF DYNJ905733K; 55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A; 56) LAP CHOLE, REF DYNJ906277D; 57) LAP CHOLE RFD, REF DYNJ906302D; 58) KIT LAP COLON RFD, REF DYNJ906315D; 59) GASTRIC SLEEVE, REF DYNJ906355D; 60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C; 61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C; 62) GEN BARIATRIC, REF DYNJ907639D; 63) LAP CHOLE, REF DYNJ908415B; 64) LAP CHOLE, REF DYNJ908415C; 65) LAPAROSCOPIC, REF DYNJ908569B; 66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G; 67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A; 68) BARIATRIC CENTRASTATE, REF DYNJ909817A; 69) LAP GENERAL THEDA, REF DYNJ910050; 70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A; 71) ROBOTIC THORACIC, REF DYNJ910386; 72) BARIATRIC, REF DYNJ911017.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

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

Recall #:
98197
Lot/product code:
REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMC376; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CMJ688; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CME476; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25CBT666; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25FBP815; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25EBN002; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25CBN212; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25FBN760; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25EBD329; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBN040; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBK313; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25CBE452; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMH793; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMC405; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25EBN676; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25DBO816; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25CBJ724; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25BBK265; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25EMG591; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25DMH851; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25CMH945; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBS490; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBI971; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25DBO242; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25CBO208; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA838; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA425; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25CBP120; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25BBN336; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25FBG772; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25EBG794; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25DBF556; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25CBQ563; REF DYNJS2032F: UDI/DI 10198459023774 (EA)40198459023775 (CS), Kit Lot Number 25EDC051; REF DYNJ26209R: UDI/DI 10198459265167 (EA)40198459265168 (CS), Kit Lot Number 25BMG526; REF DYNJ26209S: UDI/DI 10198459352614 (EA)40198459352615 (CS), Kit Lot Number 25FMA594; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25EBD946; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25CBS951; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25EBH485; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25DBK606; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25CBN430; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25FBK260; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25EBH397; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25DBT090; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25FDA326; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25CDA693; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25EMF946; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25CMG793; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25FBI408; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25CBR811; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25BBR383; REF DYNJ66285A: UDI/DI 10193489428070 (EA)40193489428071 (CS), Kit Lot Number 25DBG032; REF DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25EBA558; REF DYNJ66289B: UDI/DI 10193489950540 (EA)4019348… (truncated, 14933 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 15, 2025

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

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

Recall #:
98208
Lot/product code:
Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974
Recalling firm:
SunMed Holdings, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

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

Recall #:
98128
Lot/product code:
400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

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

Recall #:
98128
Lot/product code:
400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD10; Model Number: 722010;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

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

Recall #:
98109
Lot/product code:
Model Number: 722010; System Product Name: Allura Xper FD10; UDI-DI: 00884838059030; Serial Numbers: 764, 1396, 728, 980, 782, 125, 1096, 661, 225, 1055, 1185, 368, 743, 1006, 570, 901, 552, 973, 795, 888, 1140, 781, 1060, 354, 186, 516, 517, 64, 386, 387, 530, 996, 964, 1265, 525, 307, 1189, 98, 774, 935, 721, 254, 1008, 1213, 1273, 66, 156, 304, 1422, 388, 235, 236, 1066, 1090, 549, 689;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10

Nasal feeding tube packaged without the nasal transfer tube component.

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

Recall #:
98274
Lot/product code:
Lot Code:W4904253, W4886945, W4880750 UDI: 10827002223018
Recalling firm:
Wilson-Cook Medical Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 15, 2025

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72

Failed Impurities/Degradation Specifications

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0300-2026
Lot/product code:
Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Recalling firm:
NOVADOZ PHARMACEUTICALS LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Estrone RIA, REF: DSL8700

The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.

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

Recall #:
98219
Lot/product code:
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Recalling firm:
Immunotech A.S.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD20; Model Number: 722006;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

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

Recall #:
98109
Lot/product code:
Model Number: 722006; System Product Name: Allura Xper FD20; UDI-DI: N/A; Serial Numbers: 1370, 1376, 225, 249, 1273, 1496, 707, 1466, 1141, 1201, 359, 105, 285, 1433, 822, 1747, 318, 797, 124, 1518, 384, 1045, 328, 302, 1536, 514, 910, 2123, 1360, 1381, 149, 379, 387, 1733, 197, 314, 888, 189, 310, 209, 863, 325, 378, 2110, 166, 118, 1978, 304, 1696, 2524, 248, 1928, 294, 804, 1227, 56, 245, 1560, 1795, 902, 1295, 1123, 1424, 1958, 40, 1222, 1947, 2289, 1687, 2304, 666, 2086, 958, 1801, 2546, 1317, 1478, 589, 2154, 1557, 1580, 519, 273, 157, 1504, 836, 1365, 393, 2428, 1902, 2433, 1521, 115, 2023, 1003, 1509, 1494, 2171, 2391, 867, 1513, 29, 951, 1814, 284, 482, 455, 1763, 1899, 1968, 837, 856, 1537, 93, 1561, 1746, 1232, 430, CV.797, 1974, 507, 1949, 1275, 1427, 1967, 374, 116, CV.507, 7567201, 2225, 267, 931, 344, 745, 233, 506, 2230, 1864, 457, 280, 1556, 640, 2;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

Access Port System tray may develop cracks potentially resulting in a sterility breach.

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

Recall #:
98187
Lot/product code:
REF: 430073 UDI: 00886874119549 Lot Numbers: U80240110 K10250114 K10250305 K10250306 K10250313 K10250414 K10250424 K10250514 K10250522 K10250619 K10250626 K10250629 K10250630 K10250710 K10250716 K10250717 K10250731 K10250804 K10250806 K10250828 K10250904 K11250113 K11250807 K11250821 K11250828 K11250911 K12250821 U10241101 U10241115 U10250108 U10250207 U10250210 U10250307 U10250310 U10250313 U10250321 U10250325 U10250331 U10250414 U10250425 U10250506 U10250509 U10250521 U10250528 U10250604 U11241101 U11241121 U11241210 U11250123 U11250219 U11250404 U11250425 U11250521 U12250219 U80231207 U80231219 U80240118 U80240125 U80240201 U80240222 U80240306 U80240319 U80240402 U80240411 U80240417 U80240523 U80240617 U80240620 U80240806 U80240812 U80240905 U80240911 U80241017 U80241025 U81231219 U81240118 U81240125 U81240306 U81240319 U81240402 U81240411 U81240417 U81240617 U81240620 U81240627 U81240806 U81240905 U81240911 U82231219 REF: 430075 UDI: 00886874119556 Lot Numbers: U81240125 U80240201 U80240222 U80240125 U81240215 U81240208 U80240208 U81240201 U81240229 U80240326 U80240529 U80240229 U81240222 U80240711 U81240606 U80240606 U80240812 U80240731 U80240917 U10241107 U80241003 U10241217 U10250123 U10250305 U10250219 U10250102 K10250313 U10250414 U10250423 K10250529 K10250522 U10250529 K10250701 K10250702 K10250717 K11250814 K10250807 K11250813 K10250605 U80240611 K10250327 U80240425 U10250312 K10250515 K11250515 U10250318 U80240724 U10250115 U10250326 U80240130 U80240627 K10250113 K11250529 K10250723 U80240717 U80240215 U10250501 K10250403 U10250515 K12250904
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD10/10; Model Number: 722027;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
98109
Lot/product code:
Model Number: 722027; System Product Name: Allura Xper FD10/10; UDI-DI: 00884838054196; Serial Numbers: 298, 246, 146, 170, 238, 162, 7, 99, 81, 126, 55, 86, 6, 259, 205, 60, 57, 63, 145, 182, 48, 278;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD20/20; Model Number: 722038;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
98109
Lot/product code:
Model Number: 722038; System Product Name: Allura Xper FD20/20; UDI-DI: 00884838054226; Serial Numbers: 11, 117, 110, 134, 64, 90, 124, 72;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD10; Model Number: 722003;

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

ALL 50 STATES
▸Full report

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

Recall #:
98109
Lot/product code:
Model Number: 722003; System Product Name: Allura Xper FD10; UDI-DI: N/A; Serial Numbers: 1232, 967, 746, 1276, 232, 385, 1663, 1189, 81, 700, 167, 1072, 994, 150, 135, 1268, 168, 855, 213, 60, 471, 153, 319, 1159, 162, 180, 142, 1205, 719, 926, 426, 1413, 798, 65, 1165, 1658, 1193, 1778, 2933, 1585, 1380, 1706, 1613, 1685, 1297, 1388, 1522, 1238, 1416, 1448, 536, 1090, 1662, 1083, 1433, 1399, 62, 943, 249, 1227, 163, 1121, 1119, 889, 861, 1649, PP0200000118, 804, 1527, 468, 1593, 1198, 1022, 708, 1054, 865, 744, 1760, 936, 782, 953, 1035, 1058, 179, 1254, 1112, 389, 1560, 1660, 1013, 25, 215, 27;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)