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Recalls affecting South Dakota

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

16,209 recalls found

Just announced

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

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸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 Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸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

Lipofit — Lipofit 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

Kofinas — Garlic 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 Temptations — Chocolatey 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 Sprouts — Robust 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

Martina — Mangoes

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)
NewestOldest
High riskLow riskAll
Wording
Class IHigh risk
DrugRecalled July 17, 2026

Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

Presence of Particulate Matter; identified as stainless steel

ALL 50 STATES
▸Full report

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

Recall #:
D-0744-2026
Lot/product code:
Lot # V24010V1, Exp 3/31/2027
Recalling firm:
Sunny Pharmtech Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2026

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

Presence of Particulate Matter; identified as stainless steel

ALL 50 STATES
▸Full report

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

Recall #:
D-0743-2026
Lot/product code:
Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Recalling firm:
Sunny Pharmtech Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2026

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

ALL 50 STATES
▸Full report

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

Recall #:
99450
Lot/product code:
UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
Recalling firm:
Remel Europe Ltd.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0739-2026
Lot/product code:
Lot: 25141586, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

Presence of Particulate Matter: Hair was found in products

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-0726-2026
Lot/product code:
Lot #: 6133801, Exp. Date 01/2028
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

ALL 50 STATES
▸Full report

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

Recall #:
99459
Lot/product code:
Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
Recalling firm:
Biofire Defense
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0737-2026
Lot/product code:
Lot: 25141583, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0738-2026
Lot/product code:
Lot: 25141585, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

ALL 50 STATES
▸Full report

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

Recall #:
99441
Lot/product code:
UDI/DI 7630031707055, Lot ZVFV5
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Presence of Particulate Matter: Hair was found in product

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-0725-2026
Lot/product code:
Lot #: 6134349, 6134620 Exp. Date 11/2026
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

Presence of Particulate Matter: Hair was found in products

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-0729-2026
Lot/product code:
Lot #: 6133986, Exp. Date 02/2029
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Presence of Particulate Matter: Hair was found in products

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-0727-2026
Lot/product code:
Lot #: 6133436, Exp. Date 10/2028
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

ALL 50 STATES
▸Full report

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

Recall #:
99422
Lot/product code:
UDI: (01)00884838099258(21)1229, (01)00884838099258(21)450, (01)00884838085251(21)302, (01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)1578, (01)00884838099241(21)324, (01)00884838099241(21)585, (01)00884838099241(21)332, (01)00884838099258(21)750, (01)00884838099241(21)312, (01)00884838099241(21)85, (01)00884838099258(21)409, (01)00884838085268(21)1023, (01)00884838099272(21)125, (01)00884838099272(21)127, (01)00884838099272(21)126, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099258(21)295, (01)00884838099272(21)124, (01)00884838099272(21)120, (01)00884838099258(21)277, (01)00884838099258(21)262, (01)00884838099258(21)261, (01)00884838099258(21)272, (01)00884838099258(21)275, (01)00884838085367(21)547, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838085251(21)585, (01)00884838099258(21)1315, (01)00884838085268(21)645, (01)00884838085251(21)410, (01)00884838085268(21)646, (01)00884838099258(21)3526, (01)00884838099258(21)2744, (01)00884838099258(21)3698, (01)00884838099258(21)959, (01)00884838099258(21)381, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838099258(21)1371, (01)00884838099241(21)533, (01)00884838085268(21)1387, (01)00884838099272(21)153, (01)00884838099258(21)1019, (01)00884838085268(21)460, (01)00884838099258(21)260, (01)00884838085251(21)753, (01)00884838085268(21)35, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838099272(21)67, (01)00884838099258(21)1049, (01)00884838099258(21)3045, (01)00884838099258(21)3044, (01)00884838099258(21)3107, (01)00884838099258(21)2258, (01)00884838099258(21)1484, (01)00884838099272(21)209, (01)00884838099258(21)2573, (01)00884838099258(21)3514, (01)00884838099258(21)1083, (01)00884838099258(21)3314, (01)00884838085268(21)703307, (01)00884838099258(21)2436, (01)00884838099258(21)2184, (01)00884838099241(21)479, (01)00884838099272(21)271, (01)00884838099241(21)189, 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(01)00884838099272(21)1145, (01)00884838099272(21)1078, (01)00884838085268(21)703559… (truncated, 294787 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications.

ALL 50 STATES
▸Full report

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

Recall #:
99423
Lot/product code:
UDI: (01)00884838116757(21)5, (01)00884838116771(21)686, (01)00884838116771(21)521, (01)00884838116771(21)812, (01)00884838116771(21)163, (01)00884838116801(21)127, (01)00884838116757(21)34, (01)00884838116733(21)61, (01)00884838116764(21)226, (01)00884838116771(21)327, (01)00884838116764(21)277, (01)00884838116771(21)780, (01)00884838116771(21)429, (01)00884838116764(21)276, (01)00884838116788(21)87, (01)00884838116801(21)37, (01)00884838116771(21)362, (01)00884838116771(21)502, (01)00884838116740(21)77, (01)00884838116757(21)106, (01)00884838116771(21)222, (01)00884838116771(21)545, (01)00884838116801(21)159, (01)00884838116801(21)345, (01)00884838116771(21)987, (01)00884838116771(21)457, (01)00884838116801(21)136, (01)00884838116757(21)49, (01)00884838116771(21)803, (01)00884838116771(21)901, (01)00884838116771(21)347, (01)00884838116764(21)335, (01)00884838116801(21)199, (01)00884838116801(21)24, (01)00884838116771(21)902, (01)00884838116771(21)529, (01)00884838116764(21)99, (01)00884838116740(21)37, (01)00884838116801(21)421, (01)00884838116771(21)718, (01)00884838116801(21)212, (01)00884838116764(21)122, (01)00884838116801(21)17, (01)00884838116764(21)344, (01)00884838116771(21)287, (01)00884838116757(21)140, (01)00884838116764(21)169, (01)00884838116771(21)822, (01)00884838116801(21)25, (01)00884838116801(21)180, (01)00884838116771(21)88, (01)00884838116788(21)127, (01)00884838116771(21)363, (01)00884838116801(21)227, (01)00884838116771(21)716, (01)00884838116771(21)185, (01)00884838116771(21)1145, (01)00884838116771(21)426, (01)00884838116801(21)235, (01)00884838116771(21)292, (01)00884838116771(21)252, (01)00884838116801(21)131, (01)00884838116771(21)332, (01)00884838116771(21)993, (01)00884838116771(21)97, (01)00884838116771(21)359, (01)00884838116771(21)1088, (01)00884838116764(21)350, (01)00884838116771(21)893, (01)00884838116801(21)288, (01)00884838116771(21)346, (01)00884838116771(21)695, (01)00884838116771(21)383, (01)00884838116771(21)300, (01)00884838116771(21)804, (01)00884838116801(21)504, (01)00884838116771(21)186, (01)00884838116764(21)267, (01)00884838116771(21)1354, (01)00884838116771(21)1246, (01)00884838116771(21)99, (01)00884838116771(21)413, (01)00884838116801(21)231, (01)00884838116771(21)547, (01)00884838116771(21)449, (01)00884838116757(21)99, (01)00884838116801(21)203, (01)00884838116771(21)75, (01)00884838116771(21)813, (01)00884838116801(21)138, (01)00884838116771(21)447, (01)00884838116771(21)915, (01)00884838116771(21)511, (01)00884838116788(21)117, (01)00884838116801(21)426, (01)00884838116801(21)20, (01)00884838116771(21)484, (01)00884838116801(21)249, (01)00884838116757(21)392, (01)00884838116771(21)626, (01)00884838116771(21)215, (01)00884838116764(21)96, (01)00884838116771(21)704, (01)00884838116764(21)108, (01)00884838116771(21)248, (01)00884838116771(21)594, (01)00884838116771(21)87, (01)00884838116771(21)333, (01)00884838116788(21)76, (01)00884838116771(21)1226, (01)00884838116771(21)927, (01)00884838116771(21)1037, (01)00884838116771(21)1140, (01)00884838116771(21)286, (01)00884838116771(21)173, (01)00884838116771(21)395, (01)00884838116801(21)200, (01)00884838116757(21)12, (01)00884838116771(21)68, (01)00884838116801(21)468, (01)00884838116771(21)656, (01)00884838116801(21)208, (01)00884838116771(21)459, (01)00884838116771(21)848, (01)00884838116757(21)138, (01)00884838116801(21)42, (01)00884838116771(21)71, (01)00884838116771(21)465, (01)00884838116801(21)205, (01)00884838116771(21)855, (01)00884838116801(21)183, (01)00884838116757(21)101, (01)00884838116771(21)377, (01)00884838116771(21)854, (01)00884838116771(21)517, (01)00884838116771(21)330, (01)00884838116801(21)363, (01)00884838116771(21)370, (01)00884838116757(21)91, (01)00884838116771(21)660, (01)00884838116771(21)501, (01)00884838116771(21)535, (01)00884838116771(21)463, (01)00884838116771(21)320, (01)00884838116771(21)1248, (01)00884838116801(21)81, (01)00884838116771(21)817, (01)00884838116771(21)516, (01)00884838116771(21)616, (01)00884838116764(21)271, (01)00884838116757(21)127, (01)00884838116771(21)475, (01)00884838116757(21)2, (01)00884838116771(21)270, (01)00884838116757(21)96, (01)00884838116757(21)316, (01)00884838116771(21)583, (01)00884838116771(21)887, (01)00884838116771(21)549, (01)00884838116801(21)148, (01)00884838116801(21)133, (01)00884838116764(21)322, (01)00884838116757(21)124, (01)00884838116757(21)317, (01)00884838116771(21)762, (01)00884838116771(21)617, (01)00884838116771(21)703, (01)00884838116771(21)178, (01)00884838116757(21)36, (01)00884838116771(21)171, (01)00884838116788(21)188, (01)00884838116757(21)136, (01)00884838116771(21)1076, (01)00884838116771(21)847, (01)00884838116771(21)1342, (01)00884838116771(21)592, (01)00884838116771(21)211, (01)00884838116771(21)331, (01)00884838116771(21)1203, (01)00884838116788(21)88, (01)00884838116771(21)726, (01)00884838116771(21)467, (01)00884838116771(21)228, (01)00884838116801(21)31, (01)00884838116771(21)1277, (01)00884838116771(21… (truncated, 50974 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

Presence of Particulate Matter: Hair was found in products

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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-0728-2026
Lot/product code:
Lot #: 6130235, Exp. Date 02/2027
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2026

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers

A software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

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

Recall #:
99436
Lot/product code:
1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2026

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers

A software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

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

Recall #:
99436
Lot/product code:
1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
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.

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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) 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.

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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)
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

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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-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)
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.

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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 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

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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-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)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2026

Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63

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) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 4) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 5) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14813 ; 6) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 7) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 8) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 9) PN36NBCH4, UDI-DI: 10198956129863(each), 50198956129861(case), Lot Number: 14813 ; 10) PN36NBCH5, UDI-DI: 10198956131538(each), 50198956131536(case), Lot Number: 14813 ; 11) PN41ACLA9, UDI-DI: 10197106346105(each), 50197106346103(case), Lot Number: 4869 ; 12) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 13) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 14) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 15) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 16) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3024 ; 17) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3916-1 ; 18) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 7748 ; 19) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 20) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 21) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 22) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 23) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243 ; 24) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 25) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 26) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 11020 ; 27) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 28) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 29) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12641 ; 30) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13289 ; 31) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 32) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 33) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 34) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 14813 ; 35) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 36) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 37) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 16409 ; 38) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 16409 ; 39) PN41LMB10, UDI-DI: 10197106987032(each), 50197106987030(case), Lot Number: 14039 ; 40) PN41LMB11, UDI-DI: 10198956028685(each), 50198956028683(case), Lot Number: 14039 ; 41) PN41LMB12, UDI-DI: 10198956062870(each), 50198956062878(case), Lot Number: 14039 ; 42) PN41LMBLC, UDI-DI: 10888439949698(each), 50888439949696(case), Lot Number: 93845 ; 43) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 12206 ; 44) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 3916-2 ; 45) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 7748-2 ; 46) PNOCLNNHB,… (truncated, 162707 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) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

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.

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▸Full report

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

Recall #:
99380
Lot/product code:
1) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14039 ; 2) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 3) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 4) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14039 ; 5) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192-1 ; 6) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-5 ; 7) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 8) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 9) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14813 ; 10) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192 ; 11) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-1 ; 12) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-6 ; 13) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-7 ; 14) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-1 ; 15) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 6033 ; 16) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160-2 ; 17) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 10392 ; 18) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-2 ; 19) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 11020 ; 20) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1 ; 21) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160 ; 22) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1
Recalling firm:
Cardinal Health 200, LLC
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)