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Recalls affecting U.S. Virgin Islands

Data last updated: September 9, 2026 at 1:18 PM UTC

15,933 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 Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa 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. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
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)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
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/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K; 16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I; 17) OPEN HEART COMBO, Model Number: DYNJ907400F; 18) CARDIAC CABG B, Model Number: DYNJ908121C; 19) FS OPEN HEART, Model Number: DYNJ908308A; 20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D; 21) MEM CARDIAC, Model Number: DYNJ9622573AP; 22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

ALL 50 STATES
Full report

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

Recall #:
99043
Lot/product code:
1) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24LBH805; 2) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24HBM100; 3) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25ABR195; 4) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25EBS810; 5) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25FBS936; 6) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25GBX096; 7) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25IBT859; 8) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24KBE879; 9) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26DBF234; 10) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABG176; 11) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABK484; 12) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24HBQ201; 13) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25CBD369; 14) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25DBL498; 15) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD200; 16) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD223; 17) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBR405; 18) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24JBX455; 19) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBD604; 20) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBT739; 21) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25HBT720; 22) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25JBE191; 23) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25JBW220; 24) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26ABP964; 25) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26BBD028; 26) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26BBF355; 27) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26CBB249; 28) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 29) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 30) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 31) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 32) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25KBK109; 33) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 26ABD873; 34) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 26ABT718; 35) CDS840396AC, UDI-DI: 10198459639494(each), 40198459639495(case), Lot Number: 26DLA888; 36) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 37) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 38) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 39) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 40) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 41) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 42) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 25BBB644; 43) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 25BBR673; 44) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24LBM011; 45) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24LBR411; 46) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24HBW376; 47) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24JBW880; 48) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25DBP914; 49) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25EBO343; 50) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25FBN895; 51) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25FBO022; 52) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25FBS633; 53) CDS980952AP, UDI-DI: 10198459370991(each), 40198459370992(case), Lot Number: 25HBD136; 54) CDS980952AQ, UDI-DI: 10198459478420(each), 40198459478421(case), Lot Number: 25IBN076; 55) CDS980952AQ, UDI-DI: 10198459478420(each), 40198459478421(case), Lot Number: 25IBN339; 56) CDS980952AR, UDI-DI: 101984595204… (truncated, 26005 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 May 6, 2026

Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

ALL 50 STATES
Full report

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

Recall #:
99043
Lot/product code:
1) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25BDA811; 2) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDB415; 3) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDC095; 4) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25ADB324; 5) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25FDB473; 6) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25GDA336; 7) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 24FDB427; 8) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25ABH622; 9) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBA788; 10) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBF665; 11) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25DBR616; 12) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25FBA415; 13) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25HBT666; 14) DYNJ9855016X, UDI-DI: 10198459571374(each), 40198459571375(case), Lot Number: 25KBO109
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

ALL 50 STATES
Full report

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

Recall #:
99043
Lot/product code:
1) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA462; 2) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA547; 3) DYNJ8407, UDI-DI: 10198459704543(each), 40198459704544(case), Lot Number: 26DBB599
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

ALL 50 STATES
Full report

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

Recall #:
99043
Lot/product code:
1) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24GBR740; 2) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24JBP984; 3) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26DBJ110; 4) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABJ069; 5) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABL749; 6) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25CBB762; 7) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25DBG799; 8) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25EBM994; 9) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25GBW226; 10) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBA950; 11) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBT019; 12) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABH519; 13) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABT315; 14) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26BBQ338
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

ALL 50 STATES
Full report

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

Recall #:
99043
Lot/product code:
1) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25BDA811; 2) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDB415; 3) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDC095; 4) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25ADB324; 5) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25FDB473; 6) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25GDA336; 7) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 24FDB427; 8) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25ABH622; 9) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBA788; 10) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBF665; 11) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25DBR616; 12) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25FBA415; 13) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25HBT666; 14) DYNJ9855016X, UDI-DI: 10198459571374(each), 40198459571375(case), Lot Number: 25KBO109
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

ALL 50 STATES
Full report

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

Recall #:
98838
Lot/product code:
1. Material: 333867; UDI-DI Primary/Unit of Use: 4046964180842/4046964180835; Batch Numbers: 0061965993, 0061968406, 0061971306, 0061971487, 0061978629, 0061978630; 2. Material: 333862; UDI-DI Primary/Unit of Use: 4046964180743/4046964180736; Batch Numbers: 0061947858, 0061954126, 0061970779, 0061970781, 0061970783; 3. Material: 332607; UDI-DI Primary/Unit of Use: 4046964558757/4046964558740; Batch Number: 0061976109; 4. Material: 333868; UDI-DI Primary/Unit of Use: 4046964180866/4046964180859; Batch Numbers: 0061958120, 0061958276, 0061960474, 0061960475, 0061960476, 0061960477, 0061960478, 0061965732, 0061965733, 0061965734, 0061965735, 0061965736, 0061965737, 0061965738, 0061965739, 0061965740, 0061965741, 0061965743, 0061969393, 0061969394, 0061969395, 0061969397, 0061969438, 0061969439, 0061969440, 0061969441, 0061970674, 0061970675, 0061970726, 0061970727, 0061970729, 0061970730, 0061971108, 0061975011, 0061975012, 0061975013, 0061975014, 0061975015, 0061975016, 0061975017, 0061975018, 0061976996, 0061976997, 0061976998, 0061976999, 0061979852; 5. Material: 333865; UDI-DI Primary/Unit of Use: 4046964180804/4046964180798; Batch Numbers: 0061952152, 0061964964, 0061968295; 6. Material: 333871; UDI-DI Primary/Unit of Use: 4046964180903/4046964180897; Batch Number: 0061954099; 7. Material: 333851; UDI-DI Primary/Unit of Use: 4046964180606/4046964180590; Batch Numbers: 0061954106, 0061954107, 0061954108, 0061954123, 0061954124, 0061954125, 0061954130, 0061954131, 0061954132, 0061954134, 0061954135, 0061960457, 0061960458, 0061960459, 0061960460, 0061960461, 0061965687, 0061965688, 0061965689, 0061967621, 0061967623, 0061967624, 0061967626, 0061969508, 0061969986, 0061970102, 0061970104, 0061970105, 0061970106, 0061970107, 0061970109, 0061970110, 0061970860, 0061970861, 0061970863, 0061970864, 0061970866, 0061970867, 0061971261, 0061971262, 0061971263, 0061971264, 0061971265, 0061971266, 0061971268, 0061971269, 0061972812, 0061972813, 0061974198, 0061974199, 0061974200, 0061974201, 0061974247, 0061974248, 0061974249, 0061974250, 0061974251, 0061974253, 0061974559, 0061974562, 0061974563, 0061974564, 0061974569, 0061975004, 0061975005, 0061975006, 0061975007, 0061975008, 0061975009, 0061975810, 0061976903, 0061976904, 0061976905, 0061976906, 0061976908, 0061976909, 0061976910, 0061976911, 0061976912, 0061976913, 0061976914, 0061976915, 0061979785, 0061979786, 0061979787, 0061979788, 0061979790, 0061979791, 0062019490;
Recalling firm:
B Braun Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 6, 2026

Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

ALL 50 STATES
Full report

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

Recall #:
99043
Lot/product code:
1) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA462; 2) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA547; 3) DYNJ8407, UDI-DI: 10198459704543(each), 40198459704544(case), Lot Number: 26DBB599
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Software anomaly that causes a false display of error code 5018.

ALL 50 STATES
Full report

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

Recall #:
99064
Lot/product code:
Model No. MD2300F-001507; UDI-DI 00810071230226; Serial No. MDUF250342, MDUF250400, MDUF250429, MDUF250060, MDUF250061, MDUF250067, MDUF250068, MDUF250069, MDUF250071, MDUF250076, MDUF250083, MDUF250086, MDUF250091, MDUF250092, MDUF250104, MDUF250131, MDUF250133, MDUF250134, MDUF250159, MDUF250160, MDUF250199, MDUF250200, MDUF250202, MDUF250203, MDUF250204, MDUF250205, MDUF250240, MDUF250241, MDUF250242, MDUF250278, MDUF250297, MDUF250299, MDUF250312, MDUF250314, MDUF250325, MDUF250340, MDUF250341, MDUF250351, MDUF250352, MDUF250355, MDUF250367, MDUF250368, MDUF250370, MDUF250380, MDUF250384, MDUF250385, MDUF250395, MDUF250399, MDUF250409, MDUF250410, MDUF250427, MDUF250430, MDUF250431, MDUF250433, MDUF260009, MDUF260010, MDUF260011, MDUF260017, MDUF260019, MDUF260023, MDUF260024, MDUF260025, MDUF260026, MDUF260027, MDUF260032, MDUF260043, MDUF260067, MDUF260068, MDUF260070, MDUF260072, MDUF260077, MDUF260079, MDUF260094, MDUF260095, MDUF260096, MDUF260097, MDUF260098, MDUF260099, MDUF260100, MDUF260101, MDUF260103, MDUF260104, MDUF260105, MDUF260106, MDUF260107, MDUF260108, MDUF260109, MDUF260112, MDUF260115, MDUF250014, MDUF250015, MDUF250016, MDUF250050, MDUF250051, MDUF250052, MDUF250053, MDUF250054, MDUF250055, MDUF250056, MDUF250057, MDUF250058, MDUF250059, MDUF250062, MDUF250063, MDUF250064, MDUF250065, MDUF250066, MDUF250070, MDUF250072, MDUF250073, MDUF250074, MDUF250075, MDUF250084, MDUF250085, MDUF250088, MDUF250089, MDUF250090, MDUF250093, MDUF250102, MDUF250103, MDUF250105, MDUF250132, MDUF250145, MDUF250158, MDUF250161, MDUF250162, MDUF250198, MDUF250201, MDUF250206, MDUF250207, MDUF250220, MDUF250237, MDUF250238, MDUF250239, MDUF250243, MDUF250245, MDUF250279, MDUF250280, MDUF250295, MDUF250296, MDUF250298, MDUF250310, MDUF250311, MDUF250313, MDUF250323, MDUF250344, MDUF250348, MDUF250349, MDUF250350, MDUF250353, MDUF250357, MDUF250364, MDUF250365, MDUF250369, MDUF250371, MDUF250372, MDUF250378, MDUF250379, MDUF250381, MDUF250382, MDUF250383, MDUF250386, MDUF250393, MDUF250396, MDUF250397, MDUF250398, MDUF250407, MDUF250408, MDUF250411, MDUF250412, MDUF250428, MDUF250432, MDUF260016, MDUF260018, MDUF260020, MDUF260031, MDUF260041, MDUF260044, MDUF260069, MDUF260071, MDUF260078, MDUF260088, MDUF260089, MDUF260090, MDUF260091, MDUF260092, MDUF260093, MDUF250087, MDUF250208, MDUF250244, MDUF250324, MDUF250326, MDUF250354, MDUF250356, MDUF250394, MDUF260042, MDUF260045, MDUF260076; Software Version 2.2.
Recalling firm:
IPG Medical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 5, 2026

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

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-0556-2026
Lot/product code:
Lot: 24123460, Expires: October 31, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled May 5, 2026

Squirrel Brand Travelers Mix 16 oz can UPC 07223899166, 12 cans per case

Potential presence of Salmonella

ALL 50 STATES
Full report

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

Recall #:
H-0833-2026
Lot/product code:
BEST BY 04/30/27 BEST BY 05/28/27 BEST BY 06/24/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled May 5, 2026

Southern Style Nuts Gourmet Hunter Mix 23 oz plastic jar UPC 085839073319 and 36 oz plastic jar UPC 085839071483. 23 oz 6 jars per case case and 96 jars per display. 36 oz 6 jars per case

Potential presence of Salmonella

ALL 50 STATES
Full report

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

Recall #:
H-0831-2026
Lot/product code:
BEST BY 01/28/27 BEST BY 02/05/27 BEST BY 02/12/27 BEST BY 02/17/27 BEST BY 03/03/27 BEST BY 03/14/27 BEST BY 02/05/27 BEST BY 26/FEB/2027 BEST BY 13/MAR/2027 BEST BY 02/APR/2027
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled May 5, 2026

Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case

Potential presence of Salmonella

ALL 50 STATES
Full report

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

Recall #:
H-0836-2026
Lot/product code:
BEST BY 08/06/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled May 5, 2026

Southern Style Nuts Hunter Mix 30 oz plastic jar UPC 085839916302, 4 jars per case

Potential presence of Salmonella

ALL 50 STATES
Full report

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

Recall #:
H-0832-2026
Lot/product code:
BEST BY 01/29/27 BEST BY 02/03/27 BEST BY 02/10/27 BEST BY 02/19/27 BEST BY 02/24/27 BEST BY 03/02/27 BEST BY 03/10/27 BEST BY 03/16/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
Full report

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

Recall #:
98869
Lot/product code:
Model Number: 188A. UDI-DI: 00821925001077. All Lot Numbers
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled May 5, 2026

Squirrel Brand Town & Country Mix 16 oz can UPC 07223805251 and 7.5 oz can UPC 07223805450. 16 oz 12 cans per case. 7.5 oz 6 cans per case

Potential presence of Salmonella

ALL 50 STATES
Full report

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

Recall #:
H-0834-2026
Lot/product code:
BEST BY 05/01/27 BEST BY 05/25/27 BEST BY 05/28/27 BEST BY 02/10/27
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled May 5, 2026

Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case

Potential presence of Salmonella

ALL 50 STATES
Full report

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

Recall #:
H-0835-2026
Lot/product code:
BEST BY 23/MAR/2027 GY
Recalling firm:
JOHN B SANFILIPPO & SONS INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
Full report

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

Recall #:
98869
Lot/product code:
Model Number: 188. UDI-DI: 00821925001053. All Lot Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
Full report

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

Recall #:
98869
Lot/product code:
Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2026

Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

ALL 50 STATES
Full report

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

Recall #:
98869
Lot/product code:
Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
Full report

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

Recall #:
98994
Lot/product code:
Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21KME435; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMC247; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMB678; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21IMH919; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24CBO389; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24ABR872.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
Full report

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

Recall #:
98994
Lot/product code:
UDI/DI 10889942046126 (each), 40889942046127 (case), Lot Numbers: 25JMK709, 25FMJ661, 25CMG042, 24IME549, 24GMD004, 24CMF091, 24CME465, 24BMH490.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24EBH848; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24DBK995; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23JBP023; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23HBR067; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23FBM330; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23EBK061; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22JBG042; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22GBH864; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22DBT571; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25DMJ438; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25CMH178; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24IME720; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24HMG912; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26CMC503; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26AMB047; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 25JME109.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

Pediatric care bed; Product Designation: KayserBett IDA;

If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).

ALL 50 STATES
Full report

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

Recall #:
98820
Lot/product code:
Product Designation: KayserBett IDA; UDI-DI: 426038961IDAGU; Serial Number: 386, 387, 388, 389, 390, 391, 392, 635, 636, 637, 638, 639, 641, 642, 643, 644, 645, 646, 647, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1085, 1086, 1087, 1088, 1089, 1090, 1110, 1111, 1446, 1447, 1448, 1449, 1648, 1649, 1950, 1975, 1976, 1982, 1983, 1998, 2001, 2003, 2004, 2337, 2338, 2339, 2340, 2341, 2342, 2343, 2344, 2345, 2396, 2763, 2764, 2765, 2766, 2767, 2770, 2771, 2772, 2773, 2774, 3087, 3088, 3089, 3090, 3091, 3092, 3167, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3309, 3310, 3311, 3312, 3313, 3314, 3740, 3741, 3760, 4223, 4232, 4233, 4234, 4235, 4236, 4237, 4239, 4240, 4242, 4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250, 4567, 4568, 4569, 4570, 4571, 4572, 4573, 4574, 4575, 4576, 4577, 4578, 4579, 4580, 4581, 4582, 4583, 4584, 4986, 5238, 5254, 5255, 5256, 5257, 5258, 5259, 5637, 5919, 5920, 5921, 5922, 5923, 5924, 5925, 5926, 5937, 5938, 5939, 5940, 5948, 6332, 6338, 6339, 6340, 6341, 6342, 6343, 6344, 6345, 6346, 6347, 6351, 6355, 6795, 6796, 7176, 7177, 7178, 7179, 7180, 7181, 7182, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7190, 7191, 7192, 7193, 7194, 7195, 7617, 7618, 7619, 7620, 7621, 7622, 7623, 8242, 8243, 8244, 8245, 8588, 8589, 8590, 8591, 8592, 8593, 8594, 8595, 8596, 8597, 8598, 8599, 8600, 8601, 8602, 8603, 8608, 8609, 8691, 8704, 8912, 8921, 8922, 8923, 8924, 8925, 8926, 8927, 8928, 8929, 8930, 9725, 9726, 9727, 10350, 10351, 10352, 10819, 10820, 10821, 10822, 10823, 10824, 10825, 11186, 11367, 11368, 11369, 11370, 11371, 11372, 11797, 11798, 11799, 11800, 11801, 11802, 11803, 11804, 11805, 11806, 11807, 11808, 12247, 12248, 12249, 12250, 12251, 12252, 12253, 12254, 12255, 12256, 12257, 12397, 12398, 12399, 12782, 12783, 12963, 12964, 12965, 12966, 12967, 12968, 12969, 12970, 12971, 12972, 13486, 13487, 13488, 13489, 13490, 13491, 13492, 13493, 13494, 13495, 13496, 13497, 13912, 13913, 13914, 13915, 13916, 13917, 13918, 14942, 14944, 14952, 14953, 15912, 15913, 15914, 16403, 16404, 16405, 16406, 16407, 16408, 16409, 16410, 16411, 16984, 16985, 16986, 16987, 16988, 16989, 16990, 16991, 16992, 16993, 16994, 17577, 17578, 17579, 17580, 17581, 17582, 17583, 17584, 17585, 17586, 17587, 18494, 19112, 19113, 19114, 20151, 20152, 20153, 20154, 20155, 20156, 20157, 20158, 20963, 20964, 20965, 20966, 20967, 20968, 20969, 20970, 20972, 21192, 21193, 21194;
Recalling firm:
KAYSERBETTEN GMBH & CO. KG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
Full report

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

Recall #:
98994
Lot/product code:
UDI/DI 10197344149001 (each), 20197344149008 (case); ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
Full report

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

Recall #:
98994
Lot/product code:
UDI/DI 10198459556654 (each), 40198459556655 (case). Lot Numbers: 25KBC063, 25JBO955.
Recalling firm:
Medline Industries, LP
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