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Recalls affecting Iowa

Data last updated: September 7, 2026 at 12:15 AM UTC

16,431 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

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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.

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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 14, 2026

Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) 21-4720B, UDI-DI: 10888439934663(each), 50888439934661(case), Lot Number: 94970 ; 2) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10339 ; 3) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10586 ; 4) PECGMLBOB, UDI-DI: 10197106067406(each), 50197106067404(case), Lot Number: 4366 ; 5) PECGNAAU8, UDI-DI: 10197106967706(each), 50197106967704(case), Lot Number: 12206 ; 6) PECGNAAUJ, UDI-DI: 10197106894514(each), 50197106894512(case), Lot Number: 11851 ; 7) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14813 ; 8) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14039 ; 9) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 8160-1 ; 10) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 3747 ; 11) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 12) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 13) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 14) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 15) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 16) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 17) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 13289 ; 18) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 19) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 20) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 21) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 22) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10586 ; 23) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11851 ; 24) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 25) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-4 ; 26) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: N/A ; 27) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-5 ; 28) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-7 ; 29) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 30) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 31) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463 ; 32) PN21OTMC6, UDI-DI: 10195594763718(each), 50195594763716(case), Lot Number: 3024 ; 33) PN21OTMC7, UDI-DI: 10197106267660(each), 50197106267668(case), Lot Number: 6033 ; 34) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 4730 ; 35) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 93845 ; 36) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3024 ; 37) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-1 ; 38) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-2 ; 39) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-3 ; 40) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390 ; 41) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390-1 ; 42) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7748 ; 43) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-1 ; 44) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 8160-1 ; 45) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-2 ; 46) PN21OTMCD, UD… (truncated, 83479 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 14, 2026

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
3790) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4730 ; 3791) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 2221315564 ; 3792) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 338058 ; 3793) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4869 ; 3794) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3795) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3796) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3797) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3798) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3799) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 9243-1 ; 3800) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 3024-2 ; 3801) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 3916-2 ; 3802) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243 ; 3803) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-2 ; 3804) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-2 ; 3805) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 11020 ; 3806) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 11020 ; 3807) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 11020 ; 3808) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 10586 ; 3809) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 14813 ; 3810) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15192-1 ; 3811) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15463 ; 3812) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15463-6 ; 3813) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15463-7 ; 3814) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 6865 ; 3815) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-1 ; 3816) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 10339 ; 3817) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-1 ; 3818) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 11020 ; 3819) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 11020 ; 3820) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 10586 ; 3821) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15192 ; 3822) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15192 ; 3823) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15463 ; 3824) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15463-3 ; 3825) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 15463-3 ; 3826) SNE30CNV10, UDI-DI: 10198956041448(each), 50198956041446(case), Lot Number: 14039 ; 3827) SNE30CNV10, UDI-DI: 10198956041448(each), 50198956041446(case), Lot Number: 14039 ; 3828) SNE30CNV10, UDI-DI: 10198956041448(each), 50198956041446(case), Lot Number: 9243-1 ; 3829) SNE30CNV11, UDI-DI: 10198956043138(each), 50198956043136(case), Lot Number: 14039 ; 3830) SNE30CNV11, UDI-DI: 10198956043138(each), 50198956043136(case), Lot Number: 14039 ; 3831) SNE30CNV11, UDI-DI: 10198956043138(each), 50198956043136(case), Lot Number: 10586 ; 3832) SNE30CNV11, UDI-DI: 10198956043138(each), 50198956043136(case), Lot Number: 11020 ; 3833) SNE30CNV12, UDI-DI: 10198956064638(each), 50198956064636(case), Lot Number: 14039 … (truncated, 620832 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 14, 2026

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

ALL 50 STATES
Full report

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

Recall #:
99498
Lot/product code:
UDI:10845854042472, Lot number 1513167
Recalling firm:
ConMed Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1

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-0716-2026
Lot/product code:
Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1

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-0718-2026
Lot/product code:
Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE ROSEVILLE , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) SEN73NSKCF, UDI-DI: 10888439509304(each), 50888439509302(case), Lot Number: 3024-2 ; 2) SNE30CNOHE, UDI-DI: 10195594506230(each), 50195594506238(case), Lot Number: 93845 ; 3) SNE30CRJGY, UDI-DI: 10195594453992(each), 50195594453990(case), Lot Number: 4730 ; 4) SNE43NEE13, UDI-DI: 10198956470965(each), 50198956470963(case), Lot Number: 14039 ; 5) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 6033 ; 6) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 4366 ; 7) SNE5CLPB13, UDI-DI: 10197106328132(each), 50197106328130(case), Lot Number: 7390 ; 8) SNE69PSKR4, UDI-DI: 10197106895580(each), 50197106895588(case), Lot Number: 13673 ; 9) SNE7CSHY15, UDI-DI: 10197106979006(each), 50197106979004(case), Lot Number: 13673 ; 10) SNE7CSHY16, UDI-DI: 10198956026582(each), 50198956026580(case), Lot Number: 14813 ; 11) SOP30ODSCL, UDI-DI: 10197106705599(each), 50197106705597(case), Lot Number: 14813
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

Failed Impurities/Degradation 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-0741-2026
Lot/product code:
Lot # 506033, Exp Date: 11/30/2026.
Recalling firm:
Precision Dose Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1

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-0715-2026
Lot/product code:
Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V, 6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1

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-0719-2026
Lot/product code:
Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 4) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 3747 ; 5) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 4366 ; 6) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 2390 ; 7) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 265098 ; 8) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7390 ; 9) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7575 ; 10) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 8160 ; 11) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 12) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 13) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 14) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 15) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 16) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 11020 ; 17) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 18) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 19) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 20) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 21) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-1 ; 22) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-2 ; 23) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 9243-1 ; 24) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10339 ; 25) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8160 ; 26) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 11020 ; 27) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 28) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 29) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 30) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 12206 ; 31) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 32) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 33) PE33HNCR1, UDI-DI: 10197106715765(each), 50197106715763(case), Lot Number: 10339 ; 34) PE33HNCR2, UDI-DI: 10197106973325(each), 50197106973323(case), Lot Number: 10586 ; 35) PE33HNCR3, UDI-DI: 10197106997628(each), 50197106997626(case), Lot Number: 11020 ; 36) PE33HNCR4, UDI-DI: 10198956051201(each), 50198956051209(case), Lot Number: 10586 ; 37) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 38) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 39) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4366 ; 40) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4730 ; 41) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-3 ; 42) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-2 ; 43) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-1 ; 44) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 7044 ; 45) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 8160 ; 46) PE33HNCRA, UDI… (truncated, 222174 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 14, 2026

Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

ALL 50 STATES
Full report

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

Recall #:
99380
Lot/product code:
1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

ALL 50 STATES
Full report

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

Recall #:
99498
Lot/product code:
UDI:10845854042472, Lot number 1513167
Recalling firm:
ConMed Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1

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-0722-2026
Lot/product code:
Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2

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-0717-2026
Lot/product code:
Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2026

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2

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-0721-2026
Lot/product code:
Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08
Recalling firm:
Rohto-Mentholatum (Vietnam) Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

ALL 50 STATES
Full report

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

Recall #:
99447
Lot/product code:
Lot Code: D387/UDI: 00630414976891
Recalling firm:
Siemens Healthcare Diagnostics Products Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

ALL 50 STATES
Full report

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

Recall #:
99374
Lot/product code:
Model/UDI-DI Serial Numbers: MMT-1885CLW/00763000442187, 00763000974374/NG3150737H, NG3155194H, NG3151561H, NG3154693H, NG3151716H, NG3153547H, NG3153637H, NG3155407H, NG3152666H, NG3155788H, NG3081975H, NG2901117H, NG3080842H, NG3081463H, NG3153416H, NG3081894H, NG3153781H, NG3155944H, NG3081982H, NG3081525H, NG3155909H, NG3090722H, NG3154897H, NG3088436H, NG3088708H, NG3090073H, NG3155908H, NG3150720H, NG3092957H, NG3128715H, NG3128784H, NG3152774H, NG3153929H, NG3514566H, NG3150780H, NG3151290H, NG3151508H, NG3507161H, NG3508693H, NG3081976H, NG3151460H, NG3152051H, NG3152085H, NG3152344H, NG3153213H, NG3152772H, NG3155586H, NG3150786H, NG3153214H, NG3153385H, NG3151840H, NG3082019H, NG3153405H, NG3153788H, NG3153908H, NG3154527H, NG3151598H, NG2854971H, NG3155196H, NG3155202H, NG3155341H, NG3091491H, NG3155557H, NG3081498H NG3155688H, NG3155020H, NG3508565H, NG3155419H, NG3507536H, NG3091563H, NG3082036H, NG3154689H, NG3154995H, NG3508504H, NG3514345H, NG3509850H, NG3527505H, NG3514547H, NG3527469H, NG3504333H, NG3504598H, NG3505071H, NG3505220H, NG3505273H, NG3514617H, NG3506727H, NG3085044H, NG3507542H, NG3507547H, NG3514448H, NG3508303H, NG3508350H, NG3508371H, NG3514612H, NG3508511H, NG3508617H, NG3508698H, NG3508707H, NG3508757H, NG3508799H, NG3508903H, NG3509138H, NG3509295H, NG3509299H, NG3509452H, NG3509685H, NG3509689H, NG3509836H, NG3509914H, NG3509925H, NG3514375H, NG3514441H, NG3505246H, NG3505166H, NG3505283H, NG3151570H, NG3154948H, NG3514667H, NG3527165H, NG3527243H, NG3527298H, NG3527468H, NG3527480H, NG3527491H, NG3527580H, NG3527529H, NG3527543H, NG3527571H, NG3527574H, NG3092722H, NG3527581H, NG3527611H, NG3527637H, NG3527642H, NG3527672H, NG3527710H, NG3527737H, NG3527760H, NG3527865H, NG3527918H, NG3527961H, NG3527989H, NG3528017H, NG3528023H, NG3528036H, NG3528061H, NG3528120H, NG3528147H, NG3528156H, NG3528158H, NG3528180H, NG3528218H, NG3528226H, NG3528378H, NG3539964H, NG3539969H, NG3539970H, NG3539999H, NG3540001H, NG3540013H, NG3540029H, NG3540046H, NG3540053H, NG3540084H, NG3540191H, NG3540270H, NG3540310H, NG3540320H, NG3540581H, NG3540604H, NG3540628H, NG3540629H MMT-1886CLW/00763000442194, 00763000974381/NG2966956H, NG2970938H, NG2986362H, NG3013390H, NG3057910H, NG3167493H, NG3466128H, NG3098147H, NG3136398H, NG3137113H, NG3139432H, NG3143920H, NG3144721H, NG3145486H, NG3145488H, NG3471528H, NG3167609H, NG3147120H, NG3147035H, NG3430059H, NG3438451H, NG3464758H, NG3163796H, NG3166778H, NG3409587H, NG3167450H, NG3167623H, NG3167967H, NG3169694H, NG3170253H, NG3321081H, NG3409583H, NG3409611H, NG3409656H, NG3409680H, NG3409697H, NG3409716H, NG3409807H, NG3409825H, NG3409831H, NG3409854H, NG3409925H, NG3409959H, NG3410005H, NG3410053H, NG3410092H, NG3410111H, NG3410166H, NG3410189H, NG3410227H, NG3410233H, NG3410243H, NG3410279H, NG3410304H, NG3410389H, NG3410398H, NG3429103H, NG3429377H, NG3429485H, NG3429881H, NG3430107H, NG3430448H, NG3437945H, NG3437957H, NG3438394H, NG3470788H, NG3466185H, NG3466619H, NG3466620H, NG3467368H, NG3467586H, NG3468759H, NG3469430H, NG3469907H, NG3470728H, NG3168104H, NG3472157H, NG3169669H, NG3170079H, NG3430111H, NG3429099H, NG3437621H, NG3167969H, NG3465813H, NG3167397H
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Blanketrol II Model 222S; Thermal regulating system.

Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.

ALL 50 STATES
Full report

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

Recall #:
99478
Lot/product code:
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Recalling firm:
Gentherm Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Blanketrol III, Model 233; Thermal regulating system.

Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down,

ALL 50 STATES
Full report

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

Recall #:
99478
Lot/product code:
UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277
Recalling firm:
Gentherm Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

ALL 50 STATES
Full report

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

Recall #:
99403
Lot/product code:
All lot codes
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

ALL 50 STATES
Full report

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

Recall #:
99433
Lot/product code:
UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
Recalling firm:
OBP Medical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61

Weaker than it should be Drug

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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-0709-2026
Lot/product code:
Bag lot #: N02172A, N02172B, Exp. Date 07/2026; N02288A, N02288B, Exp. Date 12/2026; Blister lot #: N02172, Exp. Date 07/2026; N02288, Exp. Date 12/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT); 5) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT); 6) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMN, Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT); 7) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANT, Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT); 8) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRN, Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT); 9) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT); 10) MEDLINE HUDSON RCI,ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT); 11) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT).

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

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Full report

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

Recall #:
99403
Lot/product code:
1) Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT), UDI/DI 10197344010752 (each) 20197344010759 (case), All lot numbers; 2) Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT), UDI/DI 10197344010738 (each) 20197344010735 (case), All lot numbers; 3) Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT), UDI/DI 10197344010721 (each) 20197344010728 (case), All lot numbers; 4) Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT), UDI/DI 10197344010714 (each) 20197344010711 (case), All lot numbers; 5) Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT), UDI/DI 10197344010677 (each) 20197344010674 (case), All lot numbers; 6) Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT), UDI/DI 10197344010905 (each) 20197344010902 (case), All lot numbers; 7) Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT), UDI/DI 10197344010929 (each) 20197344010926 (case), All lot numbers; 8) Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT), UDI/DI 10197344010493 (each) 20197344010490 (case), All lot numbers; 9) Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT), UDI/DI 10197344010486 (each) 20197344010483 (case), All lot numbers; 10) Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT), UDI/DI 10197344010479 (each) 20197344010476 (case), All lot numbers; 11) Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT), UDI/DI 10197344010462 (each) 20197344010469 (case), All lot numbers;
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2026

Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

ALL 50 STATES
Full report

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

Recall #:
99403
Lot/product code:
1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers; 2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 3) Medline Product Number/SKU 780-13, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 4) Medline Product Number/SKU 780-14, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 5) Medline Product Number/SKU 780-15, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 6) Medline Product Number/SKU HUD78018, UDI/DI 10197344010660 (each) 20197344010667 (case), All lot numbers.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)