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Recalls affecting Guam

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

15,952 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/virusAnnounced 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/virusAnnounced 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)
UnclassifiedAllergenUndeclaredAnnounced 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/virusAnnounced 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/virusAnnounced 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 July 29, 2026

STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test

A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified

ALL 50 STATES
Full report

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

Recall #:
99531
Lot/product code:
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Recalling firm:
Diagnostica Stago, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: PBVMLP22G; 3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D; 4) KIT,MAJOR VAGINAL,PRESBYTERIAN, Catalog Number: PBV2MJMVH; 5) KIT, GYN LAPAROSCOPY , Catalog Number: PBV2MJMVH; 6) KIT, GYN LAPAROSCOPY , Catalog Number: PB43LSEJG; 7) GYNE ROBOTIC PACK CMC , Catalog Number: SMACGGRACE; 8) LH GYN ROBOTICS PK , Catalog Number: SMAOCGYLHL; 9) DAVINCI PACK WOMENS , Catalog Number: SMAVPDWTMC; 10) PK GYN ROBOTICS OD , Catalog Number: SMA4JGRODB; 11) PK LAPAROSCOPY GYN OD , Catalog Number: SMA4JLGODA

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PBCGRGB28, UDI-DI: 10198956432567(each), 50198956432565(case), Lot Number: GKU1823 ; 2) PBVMLP22G, UDI-DI: 10198956123854(each), 50198956123852(case), Lot Number: NGKU2052 ; 3) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856 ; 4) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957 ; 5) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856 ; 6) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957 ; 7) PBV2MJMVH, UDI-DI: 10198956285248(each), 50198956285246(case), Lot Number: NGKV3390 ; 8) PB13GYAJD, UDI-DI: 10198956125193(each), 50198956125191(case), Lot Number: NGKV3390 ; 9) PB43LSEJG, UDI-DI: 10198956200999(each), 50198956200997(case), Lot Number: NGKW2883 ; 10) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU0856 ; 11) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU2052 ; 12) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW0682 ; 13) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769 ; 14) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769 ; 15) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769 ; 16) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823 ; 17) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823 ; 18) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129 ; 19) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129 ; 20) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129 ; 21) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) KIT,ORP NEURO TRAUMA , Catalog Number: PNHDOTVCQ; 4) KIT, CRANIOTOMY PRESBYTERIAN , Catalog Number: PNV20101L; 5) KIT, LARGE SPINE 143487 , Catalog Number: PNV20101L; 6) FUSION ACCESSORY PACK BRO , Catalog Number: SNECGLFABB; 7) LH GENERAL NEURO SPINE PACK , Catalog Number: SNEOCGSLHP; 8) LH GENERAL NEURO SPINE PACK , Catalog Number: SNEOCGSL20

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2391 ; 2) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2455 ; 3) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 4) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022 ; 5) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 6) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 7) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022 ; 8) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV3390 ; 9) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 10) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390 ; 11) PN15LSRMH, UDI-DI: 10198956341692(each), 50198956341690(case), Lot Number: NGKW3769 ; 12) SNECGLFABB, UDI-DI: 10197106881675(each), 50197106881673(case), Lot Number: NGKU0856 ; 13) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 14) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769 ; 15) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW0682 ; 16) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW3769
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PWV2MF01D, UDI-DI: 10198956285255(each), 50198956285253(case), Lot Number: NGKV3390
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PEVMETBJX, UDI-DI: 10198956176041(each), 50198956176049(case), Lot Number: NGKT2394 ; 2) PEVMETBJX, UDI-DI: 10198956176041(each), 50198956176049(case), Lot Number: NGKT2394 ; 3) PEVMETB37, UDI-DI: 10198956212039(each), 50198956212037(case), Lot Number: NGKT2394
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2026

SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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-0750-2026
Lot/product code:
Lot: AC-017124, Exp. 8/30/2026; AC-017136, Exp. 12/31/2026.
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) KIT, PRIMARY RESECTION , Catalog Number: PGVMOTBB19; 4) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26; 5) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26; 6) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGV2LTNHN; 7) KIT,UMMC GENERAL MAJOR TRANSPL, Catalog Number: PG15OT92A; 8) KIT,MAJOR LITHOTOMY NEW HAN , Catalog Number: PG23MLNLD; 9) KIT, GENDER CARE , Catalog Number: PG29GCPCK; 10) KIT, GENDER CARE , Catalog Number: PG29GCPC3; 11) KIT, MUH LIVER , Catalog Number: PG33LVMNC; 12) KIT, MIS HERNIA , Catalog Number: PG35HPBJK; 13) KIT, GENERAL MAJOR , Catalog Number: PG43MJEJD; 14) KIT, OPEN THORACOTOMY CMC , Catalog Number: PVCGOTACF; 15) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYB; 16) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYC; 17) KIT, HEART II , Catalog Number: PV23HEVAE; 18) KIT, FLAP ACCESSORY , Catalog Number: PW35FABJE; 19) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 20) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PBCCGRSGD, UDI-DI: 10197106840085(each), 50197106840083(case), Lot Number: NGKU0957 ; 2) PB35GYBJC, UDI-DI: 10197106375723(each), 50197106375721(case), Lot Number: NGKU2052 ; 3) PGVMOTBB19, UDI-DI: 10198956264113(each), 50198956264111(case), Lot Number: NGKT2394 ; 4) PGVM07C26, UDI-DI: 10198956264434(each), 50198956264432(case), Lot Number: NGKT2394 ; 5) PGVM07C27, UDI-DI: 10198956292895(each), 50198956292893(case), Lot Number: NGKT2394 ; 6) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV2390 ; 7) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV3390 ; 8) PG15OT92A, UDI-DI: 10197106475041(each), 50197106475049(case), Lot Number: NGKW2883 ; 9) PG23MLNLD, UDI-DI: 10198956432024(each), 50198956432022(case), Lot Number: NGKU3969 ; 10) PG29GCPCK, UDI-DI: 10198956299207(each), 50198956299205(case), Lot Number: NGKU4716 ; 11) PG29GCPC3, UDI-DI: 10198956532496(each), 50198956532494(case), Lot Number: NGKU4716 ; 12) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 13) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 14) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 15) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994 ; 16) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0856 ; 17) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ; 18) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957 ; 19) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU2052 ; 20) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ; 21) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883 ; 22) PVCGOTACF, UDI-DI: 10195594816469(each), 50195594816467(case), Lot Number: NGKV3487 ; 23) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ; 24) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716 ; 25) PVX4TAMYC, UDI-DI: 10198956329379(each), 50198956329377(case), Lot Number: NGKU4716 ; 26) PV23HEVAE, UDI-DI: 10198956062160(each), 50198956062168(case), Lot Number: NGKT2391 ; 27) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 28) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 29) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 30) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394 ; 31) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: NGKU0129 ; 32) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: NGKU0129
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2026

SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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-0752-2026
Lot/product code:
Lot: AC-017131, Exp. 8/30/2026.
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I; 4) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 5) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 6) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB12; 7) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB17; 8) KIT, OPEN HEART CON , Catalog Number: PVCGOHCOH; 9) KIT,OPEN HEART ADULT MDST , Catalog Number: PVCGOHCPA; 10) KIT, CABG , Catalog Number: PVHDCBAGK; 11) KIT, ORP CABG , Catalog Number: PVHDCGVCP; 12) KIT, ORP CABG , Catalog Number: PVHDCGV40; 13) KIT, VALVE , Catalog Number: PVHDVAAGH; 14) KIT, ORP VALVE , Catalog Number: PVHDVPVCQ; 15) KIT, ORP VALVE , Catalog Number: PVHDVPV43; 16) KIT, MAJOR CARDIAC , Catalog Number: PVOCMGJ36; 17) KIT, OPEN HEART DH , Catalog Number: PVOCOHNHE; 18) KIT, OPEN HEART , Catalog Number: PVOCOH12O; 19) KIT, CAROTID ENDARTERECTOMY , Catalog Number: PVVMCV07E; 20) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP22R; 21) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP245; 22) KIT, THORACIC BARNES JEWISH , Catalog Number: PVVMTH22J; 23) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO22R; 24) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO241; 25) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO242; 26) KIT, THORACIC , Catalog Number: PVVXTHLCG; 27) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10R; 28) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10S; 29) KIT, MAJOR VASC, PRESBYTERIAN , Catalog Number: PVV2MJ01M; 30) KIT, CARDIAC VALVE , Catalog Number: PVV207962; 31) KIT, CARDIAC VALVE , Catalog Number: PVV207963; 32) KIT, CARDIAC VALVE , Catalog Number: PVV207964; 33) KIT, CARDIAC CABG , Catalog Number: PVV293340; 34) KIT, CARDIAC CABG , Catalog Number: PVV293362; 35) KIT, CARDIAC CABG , Catalog Number: PVV293363; 36) KIT, PUH CARDIAC CABG , Catalog Number: PVX4CAP14; 37) KIT, PUH CARDIAC , Catalog Number: PVX4CRPR7; 38) KIT, EAS THORACIC ABDOMINAL , Catalog Number: PVX4THEAA; 39) KIT, CV , Catalog Number: PV15CGSPF; 40) KIT, CV , Catalog Number: PV15CGSPG; 41) KIT,MAJOR VASCULAR , Catalog Number: PV15MJSPD; 42) KIT, OPEN HEART SET UP , Catalog Number: PV24OHN29; 43) KIT, OPEN HEART , Catalog Number: PV29OHMME; 44) KIT, OPEN HEART , Catalog Number: PV3LOHSGJ; 45) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMYB; 46) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMY3; 47) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR47; 48) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR48; 49) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR49; 50) KIT, OPEN HEART , Catalog Number: PV40OHJUD; 51) KIT, MODULE OPEN HEART , Catalog Number: PV60OH15F; 52) CV W AUX PACK 2 OF 2 CMC , Catalog Number: SCVCGPAACD; 53) THORACIC ROBOTIC PACK CMC , Catalog Number: SCVCGTRACI; 54) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG17; 55) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG18; 56) CV PACK 2 OF 2 SHER , Catalog Number: SCVCGVCS16

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PCVNCG540, UDI-DI: 10198956230057(each), 50198956230055(case), Lot Number: NGKT3319 ; 2) PCVNCG542, UDI-DI: 10198956312463(each), 50198956312461(case), Lot Number: NGKU0951 ; 3) PCVNCG55I, UDI-DI: 10197106283059(each), 50197106283057(case), Lot Number: NGKU0977 ; 4) PVCGBOB10, UDI-DI: 10198956219885(each), 50198956219883(case), Lot Number: NGKT2391 ; 5) PVCGBOB11, UDI-DI: 10198956220676(each), 50198956220674(case), Lot Number: NGKT2391 ; 6) PVCGBOB12, UDI-DI: 10198956256477(each), 50198956256475(case), Lot Number: NGKT2391 ; 7) PVCGBOB17, UDI-DI: 10198956393387(each), 50198956393385(case), Lot Number: NGKT2391 ; 8) PVCGOHCOH, UDI-DI: 10198956022270(each), 50198956022278(case), Lot Number: NGKT2391 ; 9) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 10) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 11) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKU0951 ; 12) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 13) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 14) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 15) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 16) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 17) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKW2687 ; 18) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 19) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 20) PVHDCGV40, UDI-DI: 10198956326941(each), 50198956326949(case), Lot Number: NGKV2393 ; 21) PVHDVAAGH, UDI-DI: 10197106946459(each), 50197106946457(case), Lot Number: NGKT2391 ; 22) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 23) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 24) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 25) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 26) PVHDVPV43, UDI-DI: 10198956354838(each), 50198956354836(case), Lot Number: NGKW2687 ; 27) PVOCMGJ36, UDI-DI: 10198956248663(each), 50198956248661(case), Lot Number: NGKT2391 ; 28) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 29) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 30) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2455 ; 31) PVOCOH12O, UDI-DI: 10198956202054(each), 50198956202052(case), Lot Number: NGKT2391 ; 32) PVVMCV07E, UDI-DI: 10198956179615(each), 50198956179613(case), Lot Number: NGKT2394 ; 33) PVVMFP22R, UDI-DI: 10198956179653(each), 50198956179651(case), Lot Number: NGKT2394 ; 34) PVVMFP245, UDI-DI: 10198956249141(each), 50198956249149(case), Lot Number: NGKT2394 ; 35) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 36) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0957 ; 37) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 38) PVVMTO22R, UDI-DI: 10198956161016(each), 50198956161014(case), Lot Number: NGKT2394 ; 39) PVVMTO241, UDI-DI: 10198956221741(each), 50198956221749(case), Lot Number: NGKT2394 ; 40) PVVMTO242, UDI-DI: 10198956300521(each), 50198956300529(case), Lot Number: NGKT2394 ; 41) PVVXTHLCG, UDI-DI: 10198956170759(each), 50198956170757(case), Lot Number: NGKT1789 ; 42) PVV2CC10R, UDI-DI: 10198956285262(each), 50198956285260(case), Lot Number: NGKV3390 ; 43) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV3390 ; 44) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV2390 ; 45) PVV2MJ01M, UDI-DI: 10198956285224(each), 50198956285222(case), Lot Number: NGKV3390 ; 46) PVV207962,… (truncated, 9192 characters total — see the official FDA record for the full value)
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) KIT, C SECTION , Catalog Number: PLVMCS22G; 4) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 5) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 6) KIT, C SECTION OREGON HEALTH , Catalog Number: PL57CS60N; 7) C SECTION PACK , Catalog Number: SMAHBCSECB; 8) C SECTION PACK , Catalog Number: SMAHBCSEC3

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PB41RHRM3, UDI-DI: 10198956294219(each), 50198956294217(case), Lot Number: NGKU3049 ; 2) PB41RHRM3, UDI-DI: 10198956294219(each), 50198956294217(case), Lot Number: NGKU4043 ; 3) PB41RHRM4, UDI-DI: 10197106968413(each), 50197106968411(case), Lot Number: NGKU4716 ; 4) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0957 ; 5) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0856 ; 6) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0957 ; 7) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU2052 ; 8) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU2052 ; 9) PL22CSMMI, UDI-DI: 10195594952600(each), 50195594952608(case), Lot Number: NGKU0129 ; 10) PL22CSM13, UDI-DI: 10198956457553(each), 50198956457551(case), Lot Number: NGKU0129 ; 11) PL57CS60N, UDI-DI: 10197106889848(each), 50197106889846(case), Lot Number: NGKU2052 ; 12) SMAHBCSECB, UDI-DI: 10197106958926(each), 50197106958924(case), Lot Number: NGKU4716 ; 13) SMAHBCSECB, UDI-DI: 10197106958926(each), 50197106958924(case), Lot Number: NGKU4716 ; 14) SMAHBCSECB, UDI-DI: 10197106958926(each), 50197106958924(case), Lot Number: 20251217 ; 15) SMAHBCSEC3, UDI-DI: 10198956267183(each), 50198956267181(case), Lot Number: NGKU2887
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) OVC3507231, UDI-DI: 10198956232457(each), 50198956232455(case), Lot Number: NGKU0957
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PBOCGLN17, UDI-DI: 10198956345133(each), 50198956345131(case), Lot Number: NGKV3390
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) PGOCRDNHD, UDI-DI: 10198956057012(each), 50198956057010(case), Lot Number: NGKV3390 ; 2) PG36RPEAB, UDI-DI: 10198956225091(each), 50198956225099(case), Lot Number: NGKU2052 ; 3) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487 ; 4) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2026

SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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-0748-2026
Lot/product code:
Lot: AC-017114, Exp. 11/24/2026; AC-017164, AC-017204, AC-017205, Exp. 12/31/2026.
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2026

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

ALL 50 STATES
Full report

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

Recall #:
99553
Lot/product code:
1) POV2SCCPP, UDI-DI: 10198956285200(each), 50198956285208(case), Lot Number: NGKV3390 ; 2) PWVMFFABLI, UDI-DI: 10198956123915(each), 50198956123913(case), Lot Number: NGKT2394
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2026

SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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-0749-2026
Lot/product code:
Lot: C-017115, Exp. 11/25/2026; AC-017163, Exp. 12/31/2026; AC-017169, AC-017170, AC-017171, Exp. 12/31/2026; AC-017230, AC-017231, Exp. 5/5/2027.
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2026

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3

Not guaranteed to be germ-free. The recall is due to potential contamination

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-0766-2026
Lot/product code:
Lot 2552A, Exp 09/30/2027
Recalling firm:
Prestige Brands Holdings
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2026

SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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-0747-2026
Lot/product code:
Lot: AC-017108, Exp. 11/17/2026; AC-017110, Exp. 11/20/2026; AC-017112, Exp. 11/21/2026; AC-017142, AC-017144, Exp. 12/10/2026; AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, AC-017225, Exp. 12/31/2026
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2026

SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

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-0754-2026
Lot/product code:
Lot: AC-017272, Exp. 12/12/2026.
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 28, 2026

Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01

Not guaranteed to be germ-free

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-0767-2026
Lot/product code:
Lot: 8494000002, Exp 7/31/28
Recalling firm:
Regeneron Pharmaceuticals Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2026

HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

ALL 50 STATES
Full report

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

Recall #:
99568
Lot/product code:
350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K23 23D98001134L23 23D98001634I23 23D98001722F23 23D98002004K23 23D98002054K23 23D98002059I23 23D98002086L23 23D98002225K23 23D98002639K23 23D98002649K23 23D98002771L23 23D98002897K23 23D98003187A24 23D98003188L23 23D98003198F23 23D98003221K23 23D98003523K23 23D98004710K23 23D98004956L23 23D98005238E23 23D98005242K23 23D98008495L23 23D98008520K23 23D98008591K23 23D98008832K23 23D98008910E23 23D98009571F23 23D98009597F23 23D98009629I23 23D98009835L23 23D98009905F23 23D98010830K23 23D98012539K23 23D98012748G23 23D98013452K23 23D98013684F23 23D98014324L23 23D98014750K23 23D98014988K23 23D98015098K23 23D98015120K23 23D98015207K23 23D98015221K23 23D98015222K23 23D98015231L23 23D98015571F23 23D98016139F23 23D98016168K23 23D98016187F23 23D98016436K23 23D98016463F23 23D98016490L23 23D98016718K23 23D98016725K23 23D98017989L23 23D98018269K23 23D98018271K23 23D98018272J23 23D98018274J23 23D98018277J23 23D98018280K23 23D98018284J23 23D98018285K23 23D98018286J23 23D98018287J23 23D98018290K23 23D98018291K23 23D98018292J23 23D98018294F23 23D98020005K23 23D98023298L23 23D98024058K23 23D98024075K23 23D98100344K23 23D98100567I23 23D98100620L23 23D98100627I23 23D98102225K23 23D98102340K23 23D98102422K23 23D98102666L23 23D98103547K23 23D98103822J23 23D98103971J23 23D98103972K23 23D98103973J23 23D98103974J23 23D98103975J23 23D98103976J23 23D98103977J23 23D98103979J23 23D98103980J23 23D98103981J23 23D98103982J23 23D98103983J23 23D98103984J23 23D98103985J23 23D98103988J23 23D98103989J23 23D98103990J23 23D98103991L23 23D98103992J23 23D98103993J23 23D98103994J23 23D98103995J23 23D98104017L23 23D98104195J23 23D98104196J23 23D98104197K23 23D98104198J23 23D98104199J23 23D98104231J23 23D98104232K23 23D98104234J23 23D98104235J23 23D98104236K23 23D98104237J23 23D98104238J23 23D98104239J23 23D98104240J23 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23D98110213I23 23D98110217I23 23D98110219I23 23… (truncated, 107734 characters total — see the official FDA record for the full value)
Recalling firm:
HeartSine Technologies Ltd
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 24, 2026

Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.

Failed Dissolution 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-0774-2026
Lot/product code:
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
Recalling firm:
Mylan Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 24, 2026

Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

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-0792-2026
Lot/product code:
Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;
Recalling firm:
American Regent, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 24, 2026

Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

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-0791-2026
Lot/product code:
Lot #: 24291, Exp. Date: 8/31/2026
Recalling firm:
American Regent, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 24, 2026

Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

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-0801-2026
Lot/product code:
Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
Recalling firm:
American Regent, Inc.
View official FDA record (opens in a new tab)