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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

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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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)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

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

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 November 24, 2025

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

ALL 50 STATES
▸Full report

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

Recall #:
98022
Lot/product code:
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

The devices may have a misaligned thickness control bar.

ALL 50 STATES
▸Full report

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

Recall #:
98024
Lot/product code:
Lot Code: Model No 00880100100, UDI (01)00889024375901(21)115821, Lot Number 65944745, Serial Number 115821; Model No 00880100100, UDI (01)00889024375901(21)115824, Lot Number 65944745, Serial Number 115824; Model No 00880100100, UDI (01)00889024375901(21)115826, Lot Number 65944745, Serial Number 115826; Model No 00880100100, UDI (01)00889024375901(21)115827, Lot Number 65944745, Serial Number 115827; Model No 00880100100, UDI (01)00889024375901(21)115829, Lot Number 65944745, Serial Number 115829; Model No 00880100100, UDI (01)00889024375901(21)115831, Lot Number 65944745, Serial Number 115831; Model No 00880100100, UDI (01)00889024375901(21)115832, Lot Number 65944745, Serial Number 115832; Model No 00880100100, UDI (01)00889024375901(21)115834, Lot Number 65944745, Serial Number 115834; Model No 00880100100, UDI (01)00889024375901(21)115835, Lot Number 65944745, Serial Number 115835; Model No 00880100100, UDI (01)00889024375901(21)115836, Lot Number 65944745, Serial Number 115836; Model No 00880100100, UDI (01)00889024375901(21)115838, Lot Number 65944745, Serial Number 115838; Model No 00880100100, UDI (01)00889024375901(21)115839, Lot Number 65944748, Serial Number 115839; Model No 00880100100, UDI (01)00889024375901(21)115841, Lot Number 65944748, Serial Number 115841; Model No 00880100100, UDI (01)00889024375901(21)115842, Lot Number 65944748, Serial Number 115842; Model No 00880100100, UDI (01)00889024375901(21)115843, Lot Number 65944748, Serial Number 115843; Model No 00880100100, UDI (01)00889024375901(21)115845, Lot Number 65944748, Serial Number 115845; Model No 00880100100, UDI (01)00889024375901(21)115846, Lot Number 65944748, Serial Number 115846; Model No 00880100100, UDI (01)00889024375901(21)115847, Lot Number 65944748, Serial Number 115847; Model No 00880100100, UDI (01)00889024375901(21)115848, Lot Number 65944748, Serial Number 115848; Model No 00880100100, UDI (01)00889024375901(21)115850, Lot Number 65944748, Serial Number 115850; Model No 00880100100, UDI (01)00889024375901(21)115853, Lot Number 65944748, Serial Number 115853; Model No 00880100100, UDI (01)00889024375901(21)115854, Lot Number 65944748, Serial Number 115854; Model No 00880100100, UDI (01)00889024375901(21)115855, Lot Number 65944748, Serial Number 115855; Model No 00880100100, UDI (01)00889024375901(21)115856, Lot Number 65944748, Serial Number 115856; Model No 00880100100, UDI (01)00889024375901(21)115857, Lot Number 65944748, Serial Number 115857; Model No 00880100100, UDI (01)00889024375901(21)115858, Lot Number 65944748, Serial Number 115858; Model No 00880100100, UDI (01)00889024375901(21)115859, Lot Number 65944750, Serial Number 115859; Model No 00880100100, UDI (01)00889024375901(21)115860, Lot Number 65944750, Serial Number 115860; Model No 00880100100, UDI (01)00889024375901(21)115861, Lot Number 65944750, Serial Number 115861; Model No 00880100100, UDI (01)00889024375901(21)115864, Lot Number 65944750, Serial Number 115864; Model No 00880100100, UDI (01)00889024375901(21)115865, Lot Number 65944750, Serial Number 115865; Model No 00880100100, UDI (01)00889024375901(21)115866, Lot Number 65944750, Serial Number 115866; Model No 00880100100, UDI (01)00889024375901(21)115868, Lot Number 65944750, Serial Number 115868; Model No 00880100100, UDI (01)00889024375901(21)115869, Lot Number 65944750, Serial Number 115869; Model No 00880100100, UDI (01)00889024375901(21)115872, Lot Number 65944750, Serial Number 115872; Model No 00880100100, UDI (01)00889024375901(21)115873, Lot Number 65944750, Serial Number 115873; Model No 00880100100, UDI (01)00889024375901(21)115874, Lot Number 65944750, Serial Number 115874; Model No 00880100100, UDI (01)00889024375901(21)115875, Lot Number 65944750, Serial Number 115875; Model No 00880100100, UDI (01)00889024375901(21)115877, Lot Number 65944750, Serial Number 115877; Model No 00880100100, UDI (01)00889024375901(21)115879, Lot Number 65944752, Serial Number 115879; Model No 00880100100, UDI (01)00889024375901(21)115882, Lot Number 65944752, Serial Number 115882; Model No 00880100100, UDI (01)00889024375901(21)115883, Lot Number 65944752, Serial Number 115883; Model No 00880100100, UDI (01)00889024375901(21)115884, Lot Number 65944752, Serial Number 115884; Model No 00880100100, UDI (01)00889024375901(21)115885, Lot Number 65944752, Serial Number 115885; Model No 00880100100, UDI (01)00889024375901(21)115886, Lot Number 65944752, Serial Number 115886; Model No 00880100100, UDI (01)00889024375901(21)115887, Lot Number 65944752, Serial Number 115887; Model No 00880100100, UDI (01)00889024375901(21)115889, Lot Number 65944752, Serial Number 115889; Model No 00880100100, UDI (01)00889024375901(21)115890, Lot Number 65944752, Serial Number 115890; Model No 00880100100, UDI (01)00889024375901(21)115891, Lot Number 65944752, Serial Number 115891; Model No 00880100100, UDI (01)00889024375901(21)115892, Lot Number 65944752, Serial Number 115892; Model No 00880100100, UDI (01)0088902437… (truncated, 84654 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Zimmer Dermatome AN, Model/Catalog Number: 88710100

The devices may have a misaligned thickness control bar.

ALL 50 STATES
▸Full report

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

Recall #:
98024
Lot/product code:
Lot Code: Model No 88710100, UDI 00889024464834701341, Lot Number 65900465, Serial Number 701341; Model No 88710100, UDI 00889024464834701343, Lot Number 65900465, Serial Number 701343; Model No 88710100, UDI 00889024464834701344, Lot Number 65900465, Serial Number 701344; Model No 88710100, UDI 00889024464834701345, Lot Number 65900465, Serial Number 701345; Model No 88710100, UDI 00889024464834701346, Lot Number 65900465, Serial Number 701346; Model No 88710100, UDI 00889024464834701350, Lot Number 65900465, Serial Number 701350; Model No 88710100, UDI 00889024464834701351, Lot Number 65900465, Serial Number 701351; Model No 88710100, UDI 00889024464834701352, Lot Number 65900465, Serial Number 701352; Model No 88710100, UDI 00889024464834701353, Lot Number 65900465, Serial Number 701353; Model No 88710100, UDI 00889024464834701354, Lot Number 65900465, Serial Number 701354; Model No 88710100, UDI 00889024464834701355, Lot Number 65900465, Serial Number 701355; Model No 88710100, UDI 00889024464834701356, Lot Number 65900465, Serial Number 701356; Model No 88710100, UDI 00889024464834701357, Lot Number 65900465, Serial Number 701357; Model No 88710100, UDI 00889024464834701359, Lot Number 65900465, Serial Number 701359; Model No 88710100, UDI 00889024464834701361, Lot Number 65944825, Serial Number 701361; Model No 88710100, UDI 00889024464834701362, Lot Number 65944825, Serial Number 701362; Model No 88710100, UDI 00889024464834701363, Lot Number 65944825, Serial Number 701363; Model No 88710100, UDI 00889024464834701364, Lot Number 65944825, Serial Number 701364; Model No 88710100, UDI 00889024464834701365, Lot Number 65944825, Serial Number 701365; Model No 88710100, UDI 00889024464834701366, Lot Number 65944825, Serial Number 701366; Model No 88710100, UDI 00889024464834701367, Lot Number 65944825, Serial Number 701367; Model No 88710100, UDI 00889024464834701368, Lot Number 65944825, Serial Number 701368; Model No 88710100, UDI 00889024464834701369, Lot Number 65944825, Serial Number 701369; Model No 88710100, UDI 00889024464834701370, Lot Number 65944825, Serial Number 701370; Model No 88710100, UDI 00889024464834701371, Lot Number 65944825, Serial Number 701371; Model No 88710100, UDI 00889024464834701372, Lot Number 65944825, Serial Number 701372; Model No 88710100, UDI 00889024464834701374, Lot Number 65944825, Serial Number 701374; Model No 88710100, UDI 00889024464834701375, Lot Number 65944825, Serial Number 701375; Model No 88710100, UDI 00889024464834701376, Lot Number 65944825, Serial Number 701376; Model No 88710100, UDI 00889024464834701377, Lot Number 65944825, Serial Number 701377; Model No 88710100, UDI 00889024464834701378, Lot Number 65944825, Serial Number 701378; Model No 88710100, UDI 00889024464834701379, Lot Number 65944825, Serial Number 701379; Model No 88710100, UDI 00889024464834701380, Lot Number 65944825, Serial Number 701380; Model No 88710100, UDI 00889024464834701381, Lot Number 66016265, Serial Number 701381; Model No 88710100, UDI 00889024464834701386, Lot Number 66016265, Serial Number 701386; Model No 88710100, UDI 00889024464834701387, Lot Number 66016265, Serial Number 701387; Model No 88710100, UDI 00889024464834701388, Lot Number 66016265, Serial Number 701388; Model No 88710100, UDI 00889024464834701390, Lot Number 66016265, Serial Number 701390; Model No 88710100, UDI 00889024464834701391, Lot Number 66016265, Serial Number 701391; Model No 88710100, UDI 00889024464834701393, Lot Number 66016265, Serial Number 701393; Model No 88710100, UDI 00889024464834701395, Lot Number 66016265, Serial Number 701395; Model No 88710100, UDI 00889024464834701396, Lot Number 66016265, Serial Number 701396; Model No 88710100, UDI 00889024464834701397, Lot Number 66016265, Serial Number 701397; Model No 88710100, UDI 00889024464834701398, Lot Number 66016265, Serial Number 701398; Model No 88710100, UDI 00889024464834701399, Lot Number 66016265, Serial Number 701399; Model No 88710100, UDI 00889024464834701400, Lot Number 66016265, Serial Number 701400; Model No 88710100, UDI 00889024464834701402, Lot Number 66121190, Serial Number 701402; Model No 88710100, UDI 00889024464834701403, Lot Number 66121190, Serial Number 701403; Model No 88710100, UDI 00889024464834701404, Lot Number 66121190, Serial Number 701404; Model No 88710100, UDI 00889024464834701405, Lot Number 66121190, Serial Number 701405; Model No 88710100, UDI 00889024464834701406, Lot Number 66121190, Serial Number 701406; Model No 88710100, UDI 00889024464834701410, Lot Number 66121190, Serial Number 701410; Model No 88710100, UDI 00889024464834701411, Lot Number 66121190, Serial Number 701411; Model No 88710100, UDI 00889024464834701413, Lot Number 66121190, Serial Number 701413; Model No 88710100, UDI 00889024464834701415, Lot Number 66121190, Serial Number 701415; Model No 88710100, UDI 00889024464834701416, Lot Number 66121190, Serial Number 701416; Model No 88710100, UDI 00889024464834701417, Lot Number 661211… (truncated, 44185 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein/2025043007(04/29/2027); Vivoo Ketone Test/2024013122(01/30/2026)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Male Fertility Sperm Test for Home Use (Cassette)

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Vivoo Protein Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Vivoo Protein Test/2024013122(01/30/2026)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): LotFancy Urinary Tract Infection Urine (UTI) Test Strips/2025062001(06/19/2027); LotFancy URS-3N Test Strip/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027); PALINOIA UTI-10 PARAMETER REAGENT STRIPS/2025042110(04-20-2027), 2025021001(02-20-2027); Vaunn Medical 8-in-1 Urinalysis Reagent Strip/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); JNW Direct 4-in-1 UTl Urinalysis Test Strips/30D25WC(04/29/2027), 02D25WC(04/01/2027), 30E25WC(05/29/2027), 10H24WC(07/10/2026); Urinify STRENGTH/202403103-6(01/03/2026), 202504103-6(01/01/2027), 202505103-6(06/01/2027), 202504103-3(01/01/2027), 202505103-3(06/01/2027); Urinify ESSENTIAL/202403104-6(01/03/2026), 202504104-6(01/01/2027), 202505104-6(06/01/2027), 202504104-3(01/01/2027), 202505104-3(06/01/2027); Urinify Urinary Tract Infection (UTI)/202501105-5(01/02/2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Menopause Test Cassette (Urine)

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

S. Typhi/Para Typhi A Antigen

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Vivoo pH Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Vivoo pH Test/2024013121(01/30/2026)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C Test/2024013124(01/30/2026); Vivoo Hydration Test/2024013119(01/30/2026), 2025051519(05/14/2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Vivoo Vaginal pH Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

LH One Step Ovulation Test Device (Urine)

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 21, 2025

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

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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-0199-2026
Lot/product code:
Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2025

Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

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

Recall #:
98125
Lot/product code:
UDI: 1041CE 00888277446727 (ea) 40888277446725 (case); HUD1035 10197344011575 (ea) 20197344011572 (case); HUD1042 10197344011544 (ea) 20197344011541 (case); HUD1930 10197344009626 (ea) 20197344009623 (case); HUDRHO41U 10197344010646 (ea) 20197344010643 (case) Lots: 24DOA701 25EOA321 25EOA589 25EOA724 25EOA730 25EOA781 25EOA857 25FOA151 25FOA152 25FOA153 25FOA206 25FOA218 25FOA219 25FOA220 25FOA221 25FOA275 25FOA287 25FOA288 25FOA418 25FOA419 25FOA420 25FOA421 25FOA422 25FOA514 25FOA515 25FOA524 25FOA525 25FOA551 25FOA552 25FOA553 25FOA556 25FOA557 25FOA642 25FOA643 25FOA647 25FOA648 25FOA649 25FOA650 25FOA722 25FOA740 25FOA864 25FOA865 25FOA866 25GOA055 25GOA065 25GOA066 25GOA077 25GOA078 25GOA096 25GOA098 25GOA190 25GOA210 25GOA211 25GOA328 25GOA363 25GOA364 25GOA365 25GOA366 25GOA367 25GOA437 25GOA445 25GOA446 25GOA561 25GOA562 25GOA563 25GOA564 25GOA565 25GOA640 25GOA641 25GOA648 25GOA655 25GOA735 25GOA736 25GOA756 25GOA757 25GOA758 25GOA759 25GOA760 25GOA761 25GOA766 25GOA830 25GOA994 25GOA998 25HOA009 25HOA011 25HOA017 25HOA018 25HOA019 25HOA020 25HOA021 25HOA022 25HOA060 25HOA061 25HOA071 25HOA247 25HOA249 25HOA252 25HOA253 25HOA254 25HOA255 25HOA256 25HOA316 25HOA335 25HOA372 25HOA373 25HOA452 25HOA455 25HOA456 25HOA457 25HOA458 25HOA459 25HOA460 25HOA462 25HOA469 25HOA474 25HOA478 25HOA532 25HOA533 25HOA538 25HOA629 25HOA630 25HOA631 25HOA632 25HOA633 25HOA639 25HOA644 25HOA723 25HOA724 25HOA734 25HOA829 25HOA830 25HOA831 25HOA832 25HOA833 25HOA853 25IOA020 25IOA021 25IOA090 25IOA097 25IOA163 25IOA164 25IOA165 25IOA166 25IOA244 25IOA246 25IOA247 25IOA253 25IOA363 25IOA364 25IOA365 25IOA366 25IOA367 25IOA368 25IOA369 25IOA410 25IOA438 25IOA439 25IOA520 25IOA521 25IOA522 25IOA523 25IOA524 25IOA525 25IOA526 25IOA527 25IOA637 25IOA638 25IOA668 25IOA682 25IOA683 25IOA684 25IOA685 25IOA686 25IOA687 25IOA688 25IOA743 25IOA787 25JOA027 25JOA032 25JOA047 25JOA048 25JOA049 25JOA050 25JOA051 25JOA052 25JOA053 25JOA179 25JOA213 25JOA215 25JOA243 25JOA246 25JOA247 25JOA248 25JOA249 25JOA250 25JOA251 25JOA252 25JOA253 25JOA386 25JOA430 25JOA467 25JOA561 25JOA562 25JOA563 25JOA564 25JOA579 25JOA670 25JOA675 25JOA757 25JOA758 25JOA760 25JOA762 25JOA763 25JOA778 25JOA779 25JOA780 25JOA832 25JOA835 25JOA856 25JOA940 25JOA941 25JOA942 25KOA050 25KOA051
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2025

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Emphasizing instructions for LVP duration programming located in the IFU.

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

Recall #:
98106
Lot/product code:
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2025

The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

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

Recall #:
98103
Lot/product code:
08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 20, 2025

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

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

Recall #:
97712
Lot/product code:
Firmware Version: 1.48. REF/UDI-DI: 323/10885403512667, 324/10885403512681, 352/10885403512674, 1149-00/10885403517822, 1152-00/10885403517839, 1155-00/10885403521300, 1116-00/10885403512605
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 20, 2025

Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

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

Recall #:
98028
Lot/product code:
CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected.
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2025

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01

Incorrect Product Formulation

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

Recall #:
D-0221-2026
Lot/product code:
Lot#: C274-000047958; Exp. December 19, 2025
Recalling firm:
Fagron Compounding Services
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2025

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

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

Recall #:
98032
Lot/product code:
UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2025

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

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

Recall #:
97986
Lot/product code:
Lot Code: UDI:00724995176587, 00724995176594, 00724995176570 Serial number of distributed units: 3619625011, 3621625009, 3621625012, 3621925006, 3621925009, 3622425006, 3622725007, 3623425005, 3623825002, 3624525002
Recalling firm:
Steris Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 19, 2025

AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

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

Recall #:
97986
Lot/product code:
Lot Code: UDI: 00724995176662, 00724995176679, 00724995176655 Serial numbers of distributed units: 3619725008, 3619725011, 3619725013, 3621625010, 3621625011, 3621625013, 3621625014, 3621625015, 3621925001, 3621925002, 3621925005, 3621925010, 3622425005, 3622725005, 3622725011, 3622725012, 3623125006, 3623425016, 3623825008, 3624025002, 3624025008, 3624525007
Recalling firm:
Steris Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2025

Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

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

Recall #:
98101
Lot/product code:
N/A
Recalling firm:
AGFA Healthcare Corp.
View official FDA record (opens in a new tab)