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Recalls affecting New York

Data last updated: September 8, 2026 at 1:13 PM UTC

17,381 recalls found

Just announced

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

Business Pill, Branch Manager for 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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)
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UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
▸Full report

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

Recall #:
99334
Lot/product code:
1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24ABA808; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24BBV222; 3) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24GBT333; 4) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24IBU725; 5) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 23KBX578; 6) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 23LBP536; 7) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 25BMG311; 8) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24AME318; 9) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24BMI775; 10) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24CMJ550; 11) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24IMG215; 12) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 23JME381
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010159C; 6) PEDS EMERGENCY TRAY-YELLOW, Catalog Number: ACC010160C; 7) PEDS EMERGENCY TRAY-WHITE, Catalog Number: ACC010161C; 8) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010162C; 9) PEDS EMERGENCY TRAY-RED, Catalog Number: ACC010163C; 10) CVHP DRAWER -IV, Catalog Number: ACC010308A; 11) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010316A; 12) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010318A; 13) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010319A; 14) DRAWER THREE - IV SET UP, Catalog Number: ACC010361; 15) DRAWER 1, Catalog Number: ACC010374A; 16) DRAWER 3 LAB DRAW & IV START, Catalog Number: ACC010417A; 17) DRAWER #6, Catalog Number: ACC010477B; 18) DRAWER #4, Catalog Number: ACC010479A; 19) ADULT DRAWER 4, Catalog Number: ACC010679; 20) DRAWER 2, Catalog Number: ACC010690; 21) DRAWER 2, Catalog Number: ACC010726; 22) DRAWER 2, Catalog Number: ACC010726A; 23) RRMC CODE CART DRAWER 3, Catalog Number: ACC010770; 24) DRAWER 2, Catalog Number: ACC010875; 25) BOTTOM DRAWER, Catalog Number: ACC010972; 26) CODE CART DRAWER TWO IV SUPPLI, Catalog Number: ACC010977; 27) DRAWER 4 CIRCULATION, Catalog Number: ACC011088; 28) NON-SUTURED SHEATH #113197 KIT, Catalog Number: DYKM1495; 29) SUTURED SHEATH W/SCI #113198, Catalog Number: DYKM1496; 30) LABOR TRIAGE KIT - LF #13232, Catalog Number: DYKM1564; 31) FINGER THORACOSTOMY PCC KIT, Catalog Number: DYKM2676A; 32) UVC KIT, Catalog Number: DYKM2677A; 33) CRIC KIT, Catalog Number: DYKM2678A; 34) SCOPE KIT 3, Catalog Number: DYKM2750; 35) SURGICAL KIT, Catalog Number: DYKM2752; 36) PRE OP KIT, Catalog Number: DYKS1022B; 37) MAC KIT, Catalog Number: DYKS1089B; 38) PRE OP KIT, Catalog Number: DYKS1091A; 39) PRE OP KIT, Catalog Number: DYKS1128B; 40) PRE OP KIT, Catalog Number: DYKS1325; 41) UCLA RAPID RESPONSE KIT, Catalog Number: DYLAB1097; 42) BSSM-WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3061; 43) WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3064; 44) WHOLE BLOOD/DOUBLE RED, Catalog Number: DYNDB3078C; 45) ACCESS KIT, Catalog Number: DYNDH1159A; 46) ADLT BLOOD CULTURE COLLECT KIT, Catalog Number: DYNDH1245; 47) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1362; 48) PEDIATRIC BLOOD CULTURE KIT, Catalog Number: DYNDH1363; 49) STANFORD TIME TO POSITIVITY, Catalog Number: DYNDH1591; 50) BLOOD CULTURE PINK PERIPHERAL, Catalog Number: DYNDV1875; 51) BLOOD CULTURE BLUE PERIPHERAL, Catalog Number: DYNDV1876; 52) NICU LINE PACK, Catalog Number: DYNJ63410; 53) STUDENT PRACTICE BAG W LOGO, Catalog Number: EDUC1043; 53)

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
▸Full report

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

Recall #:
99334
Lot/product code:
1) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2023122690; 2) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024020790; 3) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024032790; 4) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024052390; 5) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024071190; 6) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024081490; 7) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024101090; 8) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024111990; 9) DYNDH1983A, UDI-DI: 10653160388920(each), 00653160388923(case), Lot Number: 2025073190; 10) ACC010157C, UDI-DI: 10195327492649(each), 40195327492640(case), Lot Number: 23JDB105; 11) ACC010158C, UDI-DI: 10195327492786(each), 40195327492787(case), Lot Number: 23JDB122; 12) ACC010159C, UDI-DI: 10195327492779(each), 40195327492770(case), Lot Number: 23JDB078; 13) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDA433; 14) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDB266; 15) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDA587; 16) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDB267; 17) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDC145; 18) ACC010162C, UDI-DI: 10195327492793(each), 40195327492794(case), Lot Number: 23JDB106; 19) ACC010163C, UDI-DI: 10195327492809(each), 40195327492800(case), Lot Number: 23JDB268; 20) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25DDA404; 21) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25EDB078; 22) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDA297; 23) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDB295; 24) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25GDA555; 25) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB461; 26) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB645; 27) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23KDC062; 28) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23LDB762; 29) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 25CDB196; 30) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24DDA506; 31) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24EDA984; 32) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24LDA823; 33) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 24EDC133; 34) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 23KDA881; 35) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA262; 36) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA507; 37) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24EDB665; 38) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 23JDB228; 39) ACC010361, UDI-DI: 10889942944989(each), 40889942944980(case), Lot Number: 24ADA597; 40) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25CDB687; 41) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25EDB273; 42) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25FDA380; 43) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24ADA326; 44) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24DDC115; 45) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24EDB585; 46) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24FDA451; 47) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24JDA313; 48) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24LDA107; 49) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDB464; 50) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDC441; 51) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23LDB221; 52) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25BDA421; 53) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25FDB683; 54) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24JDA799; 55) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24KDB853; 56) ACC010417A, UDI-DI: 10195327230043(each), 4019… (truncated, 27323 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 June 12, 2026

Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
▸Full report

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

Recall #:
99334
Lot/product code:
1) DYKM1636A, UDI-DI: 10889942925858(each), 40889942925859(case), Lot Number: 25ABW688; 2) DYKM1636A, UDI-DI: 10889942925858(each), 40889942925859(case), Lot Number: 23LBT438; 3) DYKM1881A, UDI-DI: 10198459025174(each), 40198459025175(case), Lot Number: 24KBS611; 4) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 25BBB106; 5) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24KBJ751; 6) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24LBO630; 7) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24ABB622; 8) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBG290; 9) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBG291; 10) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBT163; 11) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24EBM679; 12) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24FBL963; 13) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV589; 14) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV590; 15) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV591; 16) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV592; 17) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV593; 18) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24JBV697; 19) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24JBV698; 20) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24JBV699; 21) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 23IBT699; 22) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 23JBS210
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
▸Full report

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

Recall #:
99334
Lot/product code:
1) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25ABK513; 2) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25DBM841; 3) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25EBU475; 4) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25FBQ817; 5) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25HBK086; 6) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 23LBV280; 7) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24BBN930; 8) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24DBK663; 9) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24DBS890; 10) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24FBH870; 11) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24GBR415; 12) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24HBK593; 13) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24JBE456; 14) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24JBN932; 15) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 23KBQ478; 16) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 25DLA351; 17) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 25ELA624; 18) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24BLA086; 19) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24CLA271; 20) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24DLA466; 21) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24FLA328; 22) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24GLA526; 23) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 23JLB277; 24) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 23KLB020
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
▸Full report

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

Recall #:
99334
Lot/product code:
1) DYNJ63375C, UDI-DI: 10193489851823(each), 40193489851824(case), Lot Number: 23LMC035
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
▸Full report

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

Recall #:
99334
Lot/product code:
1) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25BBG443; 2) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25EBL829; 3) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24EBR761; 4) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBC622; 5) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBX458; 6) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 23LBT973
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204

The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.

ALL 50 STATES
▸Full report

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

Recall #:
99210
Lot/product code:
UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
Recalling firm:
Tosoh Bioscience Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

ALL 50 STATES
▸Full report

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

Recall #:
D-0645-2026
Lot/product code:
Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 5338383, Exp.11/30/2028, 5343740, 6008264, Exp. 12/31/2028, 6009889, 6031246, 6033968, Exp. 1/31/2029, 6041203, 6059301, 6061876, Exp. 2/28/2029, (b) 3293904, Exp. 10/31/2026, 3333265, Exp. 11/30/2026, 4031672, 1/31/2027, 4061583, 4068589, Exp. 2/28/2027, 4081770, Exp. 3/31/2027, 4154588, 4166005, Exp. 5/31/2027, 4213945, 4215736, Exp. 7/31/2027, 4241055, Exp. 8/31/2027, 4262802, 4270628, Exp. 9/30/2027, 4309640, Exp. 10/31/2027, 5114931, Exp. 4/30/2028, 5135055, 5136752, 5143453, Exp. 5/31/2028, 5165652, Exp. 6/30/2028.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

ALL 50 STATES
▸Full report

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

Recall #:
99352
Lot/product code:
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
Recalling firm:
PHILIPS MEDICAL SYSTEMS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

ALL 50 STATES
▸Full report

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

Recall #:
99252
Lot/product code:
UDI-DI: 00191506042516; Lots: CL12917, CL13004, CL13017, CL13046, CL13060, CL13080, CL13103, CL13122, CL13123, CL13142, CL13160, CL13196, CL13212, CL13219, CL13231, CL13260, CL13291, CL13340, CL13375, CL13401, CL13422, CL13468, CL13519, CL13573, CL13578, CL13614, CL13646, CL13670, CL13671, CL13708, CL13719, CL13722, CL13732, CL13760, CL13801, CL13802, CL13820, CL13833, CL13856, CL13910, CL13911, CL13925, CL13940, CL13971, CL13972, CL13988, CL14025, CL14039, CL14050, CL14051, CL14076, CL14077, CL14119, CL14120, CL14135, CL14137, CL14171, CL14187, CL14226, CL14249, CL14286, CL14287, CL14345, CL14346, CL14375, CL14376, CL14396, CL14397, CL14439, CL14488, CL14500, CL14501, CL14518, CL14519, CL14581, CL14582, CL14633, CL14635, CL14670, CL14697, CL14711, CL14749, CL14750, CL14769, CL14770, CL14813, CL14814, CL14854, CL14855, CL14870, CL14871, CL14928, CL14929, CL14933, CL14934, CL14935, CL14968, CL14969, CL15005, CL15009, CL15067, CL15107, CL15108, CL15109, CL15128, CL15129, CL15191, CL15192, CL15193, CL15239, CL15240, CL15272, CL15318, CL15358, CL15397, CL15427, CL15474, CL15490, CL15539, CL15568, CL15569, CL15597, CL15598, CL15637, CL15638, CL15640, CL15754, CL15755, CL15775, CL15776, CL15808
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
▸Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 0052-0038; Introducer Product Code 0052-3052. GTIN: 00813502011708, 00813502012729. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

IQon Spectral CT IQon Spectral CT Upgrades

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

ALL 50 STATES
▸Full report

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

Recall #:
99352
Lot/product code:
FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542
Recalling firm:
PHILIPS MEDICAL SYSTEMS
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

ALL 50 STATES
▸Full report

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

Recall #:
D-0646-2026
Lot/product code:
Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

CTFLKSMAMDMTNYOHORVA
▸Full report

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

Recall #:
99329
Lot/product code:
UDI/DI 10198459098109 (each) 40198459098100 (case), Lot Numbers: 25AMJ225, 25CMF838, 24KME164, 25DMB248, 25FMD941, 25GMB662, 25GMG296.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
▸Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 0052-0039; Introducer Product Code 0052-3053. GTIN: 00813502011715, 00813502012736. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B: 4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C: 5) KYPHOPLASTY Medline Kit SKU DYNJ907984C: 6) LUMBAR LAMINECTOMY Medline Kit SKU DYNJ907987D: 7) KYPHOPLASTY TRAY Medline Kit SKU DYNJ908413C: 8) CRANIOTOMY Medline Kit SKU DYNJ910626: 9) NEURO SPINE Medline Kit SKU DYNJ910639.

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

CTFLKSMAMDMTNYOHORVA
▸Full report

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

Recall #:
99329
Lot/product code:
Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 24KMI926; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25BMI009; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25DME458; Medline Kit SKU DYNJ65065A, UDI/DI 10193489317244 (each) 40193489317245 (case), Lot Number 25FMC143; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24KME109; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 24LMD416; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25BMB162; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMB403; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25DMK347; Medline Kit SKU DYNJ65066B, UDI/DI 10193489317183 (each) 40193489317184 (case), Lot Number 25FMA695; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABJ808; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25ABM644; Medline Kit SKU DYNJ907718B, UDI/DI 10195327671808 (each) 40195327671809 (case), Lot Number 25BBT262; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 24LBD661; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25ABP134; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25BBS412; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25DBS673; Medline Kit SKU DYNJ907732C, UDI/DI 10195327671723 (each) 40195327671724 (case), Lot Number 25FBS372; Medline Kit SKU DYNJ907984C, UDI/DI 10198459130977 (each) 40198459130978 (case), Lot Number 25CBO351; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 24LBO744; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25ABD265; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBD596; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25CBO352; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBB260; Medline Kit SKU DYNJ907987D, UDI/DI 10198459129889 (each) 40198459129880 (case), Lot Number 25EBV317; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25EBD582; Medline Kit SKU DYNJ908413C, UDI/DI 10198459320491 (each) 40198459320492 (case), Lot Number 25FBM835; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBC117; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25DBE196; Medline Kit SKU DYNJ910626, UDI/DI 10198459050671 (each) 40198459050672 (case), Lot Number 25FBL400; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBD222; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 24LBN441; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25ABL748; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25EBF179; Medline Kit SKU DYNJ910639, UDI/DI 10198459050688 (each) 40198459050689 (case), Lot Number 25FBF363.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
▸Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 0048-0044; Introducer Product Code 0052-3046. GTIN: 00813502012200. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Not guaranteed to be germ-free: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

ALL 50 STATES
▸Full report

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

Recall #:
D-0648-2026
Lot/product code:
Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

ALL 50 STATES
▸Full report

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

Recall #:
99352
Lot/product code:
FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325
Recalling firm:
PHILIPS MEDICAL SYSTEMS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

ALL 50 STATES
▸Full report

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

Recall #:
98893
Lot/product code:
Pump Set Code 1000323; introducer Product Code 2000342. GTIN 00813502012811. All current batches in field.
Recalling firm:
Abiomed, Inc.
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Class IIModerate risk
DrugRecalled June 11, 2026

Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

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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-0663-2026
Lot/product code:
Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027
Recalling firm:
BioMed Laboratories, LLC.
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UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

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

Recall #:
98893
Lot/product code:
Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

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

Recall #:
98893
Lot/product code:
Pump Set Code 0048-0014; Introducer Product Code 0052-3046. GTIN: 00813502012873, 00813502013344, 00813502013368, 04260113630280. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

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

Recall #:
99329
Lot/product code:
Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534; Medline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772.
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

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

Recall #:
98893
Lot/product code:
Pump Set Codes 1000459, 1000460; Introducer Product Code 0052-3006-JP. GTIN: 00813502013054. All current batches in field.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)