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Recalls affecting New Hampshire

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

16,473 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

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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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 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.

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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

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)
Class IIILow risk
DrugRecalled December 16, 2025

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

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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-0248-2026
Lot/product code:
Lot# 2405003360, Exp Date: Jan 31, 2026
Recalling firm:
Alembic Pharmaceuticals Limited
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 IHigh risk
DrugUndeclaredRecalled December 15, 2025

MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of not listed on the label sildenafil and tadalafil

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

Recall #:
D-0397-2026
Lot/product code:
All codes; Exp 12/31/2029
Recalling firm:
StuffbyNainax
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

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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▸Full report

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

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

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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▸Full report

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

Allura Xper FD10/10; Model Number: 722011;

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: 722011; System Product Name: Allura Xper FD10/10; UDI-DI: 00884838059047; Serial Numbers: 268, 205, 213, 89, 293, 294, 116, 272, 113, 152, 112, 139, 141, 111, 81, 66, 46, 153, 115, 114, 274;
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

Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.515 mm and 14.525.5 mm. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO

The console label for affected devices is missing the "DANGER" symbol.

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

Recall #:
98176
Lot/product code:
Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016, C10017 UDI-DI: 08437019546076
Recalling firm:
LEASEIR TECHNOLOGIES SLU
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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.

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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.
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UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Plum Duo Infusion System, List Number 40002-04-01

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.

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

Recall #:
98129
Lot/product code:
UDI-DI: M335400021; Serial Numbers: 50000221 50000294 50000295 50000296 50000298 50000299 50000300 50000303 50000304 50000309 50001663 50001664 50001665 50001666 50001667 50001668 50001669 50001670 50001671 50001672 50001673 50001674 50001675 50001676 50001677 50001678 50001679 50001680 50001681 50001682 50001683 50001684 50001685 50001686 50001687 50001688 50001689 50001690 50001691 50001692 50001693 50001694 50001695 50001696 50001697 50001698 50001699 50001700 50001701 50001702 50001703 50001704 50001705 50001706 50001707 50001708 50001709 50001710 50001711 50001712 50001713 50001714 50001715 50001716 50001717 50001718 50001719 50001720 50001721 50001722 50001723 50001724 50001725 50001726 50001727 50001728 50001729 50001730 50001731 50001732 50001733 50001734 50001735 50001736 50001737 50001738 50001739 50001740 50001741 50001742 50001743 50001744 50001745 50001746 50001747 50001748 50001749 50001750 50001751 50001752 50001753 50001754 50001755 50001756 50001757 50001758 50001759 50001760 50001761 50001762 50001763 50001765 50001766 50001768 50001770 50001771 50001772 50001773 50001774 50001775 50001776 50001777 50001778 50001779 50001780 50001781 50001782 50001783 50001784 50001785 50001786 50001787 50001788 50001789 50001790 50001791 50001792 50001793 50001794 50001795 50001796 50001797 50001798 50001799 50001800 50001801 50001802 50001803 50001804 50001805 50001806 50001807 50001809 50001810 50001811 50001812 50001813 50001814 50001815 50001816 50001817 50001818 50001819 50001820 50001821 50001822 50001823 50001824 50001825 50001826 50001827 50001828 50001829 50001831 50001833 50001834 50001835 50001836 50001837 50001838 50001839 50001840 50001841 50001842 50001843 50001844 50001845 50001846 50001847 50002285 50003548 50003626 50003702 50003703 50003704 50003705 50003706 50003707 50003708 50003709 50003710 50003712 50003713 50003715 50003716 50003717 50003718 50003719 50003720 50003722 50003723 50003725 50003726 50003727 50003728 50003730 50003732 50003733 50003734 50003735 50003736 50003737 50003738 50003740 50003741 50003742 50003743 50003745 50003746 50003747 50003748 50003749 50003751 50003752 50003754 50003755 50003756 50003757 50003758 50003759 50003760 50003761 50003762 50003763 50003764 50003765 50003766 50003767 50003768 50003770 50003771 50003774 50003775 50003776 50003777 50003779 50003784 50003785 50003786 50003787 50003789 50003792 50003793 50003794 50003797 50003798 50003799 50003800 50003801 50003802 50003803 50003804 50003805 50003807 50004219 50004913 50004939 50005129 50005199 50000004 50000005 50000006 50000008 50000009 50000010 50000011 50000012 50000013 50000014 50000015 50000016 50000017 50000018 50000019 50000020 50000021 50000022 50000023 50000024 50000025 50000026 50000027 50000028 50000030 50000031 50000032 50000034 50000035 50000036 50000037 50000038 50000039 50000041 50000042 50000043 50000044 50000045 50000047 50000048 50000049 50000050 50000051 50000052 50000053 50000055 50000056 50000057 50000058 50000059 50000060 50000061 50000063 50000064 50000065 50000066 50000067 50000068 50000069 50000070 50000071 50000072 50000073 50000074 50000075 50000076 50000077 50000078 50000079 50000080 50000081 50000083 50000084 50000085 50000087 50000088 50000089 50000090 50000092 50000093 50000094 50000095 50000096 50000097 50000098 50000099 50000100 50000101 50000104 50000105 50000106 50000107 50000108 50000109 50000110 50000112 50000113 50000114 50000115 50000116 50000117 50000007 50000033 50000046 50000054 50000062 50000082 50000091 50000102 50000103 50000111 50000249 50000273 50000277 50000283 50000306 50000311 50003711 50003714 50003721 50003724 50003729 50003731 50003739 50003744 50003750 50003769 50003772 50003778 50003782 50003783 50003788 50003790 50003791 50003795 50003806 50003808 50003809 50003810 50004066 50004274 50004364 50001764 50001830
Recalling firm:
ICU Medical, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

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

Recall #:
98213
Lot/product code:
Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075
Recalling firm:
Sysmex America, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD20/10; Model Number: 722029;

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: 722029; System Product Name: Allura Xper FD20/10; UDI-DI: 00884838054219; Serial Numbers: 30, 81, 80, 47;
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; Model Number: 722028;

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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▸Full report

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

Recall #:
98109
Lot/product code:
Model Number: 722028; System Product Name: Allura Xper FD20; UDI-DI: 00884838054202; Serial Numbers: 893, 614;
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

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

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

Recall #:
98163
Lot/product code:
Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
Recalling firm:
Diagnostica Stago, 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
▸Full report

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

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Presence of particulates in affected devices that can be deposited into breast tissue during use.

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

Recall #:
98172
Lot/product code:
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD20 Biplane; Model Number: 722008;

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: 722008; System Product Name: Allura Xper FD20 Biplane; UDI-DI: N/A; Serial Numbers: 296, 245, 141, 260, 13, 410, 196, 476, 488, 290, 339, 474, 383, 530, 722008530, 223, 468, 63;
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: Allura Xper FD10C; Model number: 722001;

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: 722001; System Product Name: Allura Xper FD10C; UDI-DI: N/A; Serial Numbers: 166, 181, 153, 274, 296, 267, 206, 247, 161, 282, 213, 284, 103, 199, 129, 95, 299, 30, 235, 221, 348, 283, 276, 253, 1100, 78, 229, 232, 159, 177, 219, 217, 205, 3, 89, 101, 295, 305;
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: 722026;

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: 722026; System Product Name: Allura Xper FD10; UDI-DI: 00884838054189; Serial Numbers: 969, 223, 648, 664, 622, 931, 128, 616, 497, 769, 143, 881, 809, 18, 326, 794, 174, 804, 424, 587, 172, 911, 294, 569, 141, 161, 182, 928, 960, 858, 494, 628, 749, 968, 17, 273, 43, 203, 546, 104, 430, 575, 180, 594, 359, 723, 779, 632, 183, 330, 726, 637, 300, 429, 810, 995, 293, 296, 573, 917, 695, 676, 913, 274, 734, 520, 27, 940, 597, 598, 301, 818, 916, 328, 912, 691, 410, 873, 868, 816, 732, 147, 742, 651, 919, 89, 918, 346, 250, 755, 199, 255, 524, 256, 623;
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)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Allura Xper FD20 Biplane; Model Number: 722013;

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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▸Full report

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

Recall #:
98109
Lot/product code:
Model Number: 722013; System Product Name: Allura Xper FD20 Biplane; UDI-DI: 00884838059061; Serial Numbers: 601, 230, 370, 27, 320, 193, 60, 373, 560, 400, 549, 506, 381, 382, 132, 169, 233, 236, 243, 526, 447, 163, 403;
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

Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209
Recalling firm:
SunMed Holdings, LLC
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