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Recalls affecting Kansas

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

16,731 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

▸Full report
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/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) COLORECTAL ME, Model Number: DYNJ906437D

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) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 23LBL348; 2) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBA259; 3) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBN513; 4) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBS350; 5) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBU576
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) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A

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) ACC010741, UDI-DI: 10195327515515(each), 40195327515516(case), Lot Number: 23KDB215; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBT847; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBB138
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) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A

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) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023111390; 2) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023121890; 3) DYNDH1920A, UDI-DI: 10653160385943(each), 00653160385946(case), Lot Number: 2025022790
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) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT, Catalog Number: DYKS1584; 7) GENERAL PREOP KIT, Catalog Number: DYKS1584A; 8) GENERAL PREOP KIT, Catalog Number: DYKS1584B

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) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23KBL520; 2) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23LBP488; 3) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 25ABQ496; 4) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24CBI654; 5) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24DBU596; 6) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24FBA388; 7) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24GBD436; 8) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24JBC974; 9) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24KBA645; 10) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 23LBB037; 11) DYKS1216I, UDI-DI: 10198459362668(each), 40198459362669(case), Lot Number: 25GBP888; 12) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 25ABT088; 13) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24KBO407; 14) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24ABO808; 15) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24CBI736; 16) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24EBN336; 17) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24IBP255; 18) DYKS1583, UDI-DI: 10198459027666(each), 40198459027667(case), Lot Number: 24GBW364; 19) DYKS1584, UDI-DI: 10198459027659(each), 40198459027650(case), Lot Number: 24GBW365; 20) DYKS1584A, UDI-DI: 10198459146633(each), 40198459146634(case), Lot Number: 24JBA740; 21) DYKS1584B, UDI-DI: 10198459292750(each), 40198459292751(case), Lot Number: 25EBD220
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 LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A; 6) IV START W/EXT SET KIT, Model Number: DYNDV1615I

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) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 25DBN710; 2) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24BBH722; 3) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24CBV460; 4) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24EBR549; 5) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24GBH769; 6) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 23KBN939; 7) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 23LBT913; 8) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24AMB256; 9) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24BMF851; 10) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24DMC055; 11) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24FMB552; 12) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24IMF355; 13) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24KMD782; 14) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 23IMI364; 15) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 23JMG372; 16) DYKM2187, UDI-DI: 10195327232924(each), 40195327232925(case), Lot Number: 23JBQ286; 17) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 25ABI946; 18) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 25ABV328; 19) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24LBM058; 20) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24LBO554; 21) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBB880; 22) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBT739; 23) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBV226; 24) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24IBL537; 25) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24JBL006; 26) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25KME690; 27) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25AMI449; 28) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25BMB196; 29) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25BMI538; 30) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 24JMG337; 31) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 24KMH747; 32) DYNDV1615I, UDI-DI: 10195327407100(each), 40195327407101(case), Lot Number: 24DBM033
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) 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) 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)
Class IIModerate risk
DrugRecalled June 12, 2026

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05

Crystallization; identified as Buprenorphine free base

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-0596-2026
Lot/product code:
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Recalling firm:
Par Health USA, LLC
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

Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog Number: CDS983672P; 7) DYKM1982, Catalog Number: DYKM1982; 8) DYNDA1080, Catalog Number: DYNDA1080; 9) DYNJ67490C, Catalog Number: DYNJ67490C; 10) DYNJ907400D, Catalog Number: DYNJ907400D; 11) DYNJ908990A, Catalog Number: DYNJ908990A

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) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 2) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 3) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 4) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 5) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 6) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 7) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 8) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 9) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 10) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABM288; 11) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABR888; 12) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBB218; 13) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBM057; 14) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24FBH873; 15) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24HBG929; 16) CDS983348AB, UDI-DI: 10198459136986(each), 40198459136987(case), Lot Number: 25ABK077; 17) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24BBC413; 18) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24CBQ574; 19) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24IBC602; 20) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBC919; 21) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBK787; 22) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBL738; 23) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBB600; 24) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBE775; 25) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23JBR840; 26) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23KBM370; 27) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23LBD735; 28) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 25ABI289; 29) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 24LBO787; 30) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 25BBB356; 31) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 23LBU657; 32) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBF023; 33) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBL355; 34) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24KBA176; 35) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 25BBB185; 36) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24EBE506; 37) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24GBK362; 38) DYNJ67490C, UDI-DI: 10195327631710(each), 40195327631711(case), Lot Number: 24BBN881; 39) DYNJ907400D, UDI-DI: 10195327538552(each), 40195327538553(case), Lot Number: 24BBL947; 40) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25ALA775; 41) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25CLA341; 42) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24ILA196; 43) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24JLA337; 44) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24LLA178
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) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A

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) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023111390; 2) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023121890; 3) DYNDH1920A, UDI-DI: 10653160385943(each), 00653160385946(case), Lot Number: 2025022790
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) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog Number: CDS983672P; 7) DYKM1982, Catalog Number: DYKM1982; 8) DYNDA1080, Catalog Number: DYNDA1080; 9) DYNJ67490C, Catalog Number: DYNJ67490C; 10) DYNJ907400D, Catalog Number: DYNJ907400D; 11) DYNJ908990A, Catalog Number: DYNJ908990A

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) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 2) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 3) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 4) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 5) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 6) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 7) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 8) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 9) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 10) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABM288; 11) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABR888; 12) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBB218; 13) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBM057; 14) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24FBH873; 15) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24HBG929; 16) CDS983348AB, UDI-DI: 10198459136986(each), 40198459136987(case), Lot Number: 25ABK077; 17) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24BBC413; 18) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24CBQ574; 19) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24IBC602; 20) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBC919; 21) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBK787; 22) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBL738; 23) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBB600; 24) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBE775; 25) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23JBR840; 26) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23KBM370; 27) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23LBD735; 28) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 25ABI289; 29) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 24LBO787; 30) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 25BBB356; 31) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 23LBU657; 32) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBF023; 33) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBL355; 34) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24KBA176; 35) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 25BBB185; 36) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24EBE506; 37) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24GBK362; 38) DYNJ67490C, UDI-DI: 10195327631710(each), 40195327631711(case), Lot Number: 24BBN881; 39) DYNJ907400D, UDI-DI: 10195327538552(each), 40195327538553(case), Lot Number: 24BBL947; 40) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25ALA775; 41) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25CLA341; 42) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24ILA196; 43) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24JLA337; 44) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24LLA178
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) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A

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) ACC010741, UDI-DI: 10195327515515(each), 40195327515516(case), Lot Number: 23KDB215; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBT847; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBB138
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) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B

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) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24LBQ727; 2) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24JBB775; 3) DYKM2751A, UDI-DI: 10198459313301(each), 40198459313302(case), Lot Number: 25KMD727; 4) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24KBP388; 5) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24JBA739; 6) DYKS1583B, UDI-DI: 10198459292699(each), 40198459292690(case), Lot Number: 25DBM037
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) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYNJ63199A, Catalog Number: DYNJ63199A

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) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 25BBB327; 2) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24KBE261; 3) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABC301; 4) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABT704; 5) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBO246; 6) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBU663; 7) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24CBJ141; 8) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBH263; 9) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBO539; 10) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBG333; 11) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBV434; 12) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23LBM123; 13) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 25ABS139; 14) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24EBP237; 15) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24KBE336; 16) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 23JBM582; 17) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 23LBM892; 18) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 24EBG970
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01

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: 00191506043131; Lots: CL12695, CL12696, CL12699, CL12700, CL12703, CL12808, CL12816, CL12817, CL12823, CL12834, CL12835, CL12836, CL12853, CL12860, CL12882, CL12883, CL12884, CL12891, CL12907, CL12908, CL12909, CL12919, CL12949, CL12950, CL12969, CL12976, CL12979, CL12980, CL13005, CL13010, CL13011, CL13012, CL13018, CL13032, CL13033, CL13034, CL13037, CL13056, CL13057, CL13058, CL13074, CL13075, CL13076, CL13077, CL13097, CL13098, CL13099, CL13100, CL13104, CL13115, CL13116, CL13117, CL13118, CL13119, CL13135, CL13136, CL13137, CL13138, CL13139, CL13156, CL13157, CL13191, CL13192, CL13193, CL13194, CL13197, CL13208, CL13209, CL13210, CL13215, CL13216, CL13217, CL13224, CL13229, CL13230, CL13257, CL13258, CL13288, CL13289, CL13337, CL13338, CL13365, CL13366, CL13384, CL13398, CL13399, CL13419, CL13420, CL13423, CL13467, CL13469, CL13470, CL13471, CL13472, CL13517, CL13525, CL13526, CL13527, CL13528, CL13535, CL13536, CL13541, CL13550, CL13551, CL13552, CL13553, CL13555, CL13564, CL13565, CL13566, CL13571, CL13574, CL13575, CL13576, CL13598, CL13599, CL13616, CL13637, CL13642, CL13643, CL13644, CL13665, CL13666, CL13667, CL13668, CL13704, CL13705, CL13706, CL13715, CL13716, CL13721, CL13734, CL13735, CL13736, CL13761, CL13762, CL13763, CL13798, CL13799, CL13800, CL13822, CL13825, CL13826, CL13835, CL13836, CL13837, CL13858, CL13859, CL13860, CL13912, CL13913, CL13914, CL13927, CL13928, CL13929, CL13942, CL13944, CL13945, CL13974, CL13975, CL13981, CL13990, CL13991, CL13992, CL14027, CL14028, CL14029, CL14040, CL14041, CL14042, CL14053, CL14054, CL14055, CL14079, CL14080, CL14081, CL14122, CL14123, CL14124, CL14139, CL14140, CL14141, CL14169, CL14172, CL14173, CL14174, CL14188, CL14189, CL14190, CL14227, CL14228, CL14229, CL14250, CL14251, CL14252, CL14288, CL14289, CL14290, CL14347, CL14348, CL14377, CL14378, CL14398, CL14399, CL14400, CL14440, CL14441, CL14442, CL14489, CL14490, CL14492, CL14493, CL14496, CL14502, CL14505, CL14506, CL14520, CL14583, CL14584, CL14585, CL14634, CL14636, CL14637, CL14671, CL14672, CL14673, CL14674, CL14698, CL14699, CL14700, CL14712, CL14713, CL14714, CL14715, CL14751, CL14752, CL14753, CL14771, CL14772, CL14773, CL14774, CL14815, CL14816, CL14817, CL14818, CL14856, CL14857, CL14858, CL14859, CL14872, CL14873, CL14874, CL14930, CL14931, CL14932, CL14936, CL14937, CL14938, CL14970, CL14971, CL14972, CL15006, CL15007, CL15010, CL15011, CL15068, CL15069, CL15070, CL15080, CL15089, CL15110, CL15130, CL15131, CL15132, CL15194, CL15195, CL15196, CL15241, CL15242, CL15243, CL15273, CL15274, CL15275, CL15276, CL15319, CL15320, CL15321, CL15322, CL15359, CL15360, CL15361, CL15362, CL15398, CL15399, CL15400, CL15401, CL15428, CL15429, CL15430, CL15431, CL15451, CL15475, CL15476, CL15477, CL15491, CL15492, CL15493, CL15494, CL15525, CL15540, CL15541, CL15548, CL15549, CL15570, CL15583, CL15584, CL15599, CL15603, CL15617, CL15641, CL15642, CL15718, CL15756, CL15769, CL15770, CL15777
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 11, 2026

BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.

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

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▸Full report

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

Recall #:
D-0644-2026
Lot/product code:
Lot: 4298581, expires: 09/30/2026.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

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

Recall #:
99230
Lot/product code:
GTIN 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.
Recalling firm:
Boston Scientific Corporation
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Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; 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

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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-0650-2026
Lot/product code:
Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.
Recalling firm:
CareFusion 213, LLC
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Class IIModerate risk
DrugRecalled June 11, 2026

BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB

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

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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-0651-2026
Lot/product code:
Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

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▸Full report

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

Recall #:
99230
Lot/product code:
GTIN 00191506042547, Serial Numbers: 106247020.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2026

ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer 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.

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

Recall #:
98893
Lot/product code:
Pump Set Code 1000441; Introducer Product Code 2000342. GTIN: 00813502012910. 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 (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, 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

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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-0643-2026
Lot/product code:
Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
Recalling firm:
CareFusion 213, LLC
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 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, 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 1000550; Introducer Product Code 0052-3046. GTIN: 00813502013474. 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 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)