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Recalls affecting Puerto Rico

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

16,258 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 26ABM977; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25KBM387; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25IBG995; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25GBW704; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 26AMF231; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 25GMC304.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

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

Recall #:
98552
Lot/product code:
Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025.
Recalling firm:
B Braun Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

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▸Full report

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

Recall #:
98552
Lot/product code:
Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025
Recalling firm:
B Braun Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline Kit Number/SKU DYNJ902935K; 11. OCULAR, Medline Kit Number/SKU DYNJ909065; 12. OCULAR, Medline Kit Number/SKU DYNJ909065A.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU DYNJ48725A: UDI/DI each 10193489853896, UDI/DI case 40193489853897, Lot Number: 24IMG757; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22FME241; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22DMC340; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21JMC829; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21IMC497; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21HMD139; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21GME747; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21FMA440; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21DBU602; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21CBJ936; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23IBC227; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23FBA458; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23DBC239; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23ABI841; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBP260; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBO842; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBN801; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22GBL794; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24HBB998; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24DBQ664; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24CBQ260; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 26ABC645; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25LBB014; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25JBM975; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25HBN493; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25GBM010; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25FBJ206; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25CBN002; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABF979; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABA086; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBE583; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBG667; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25KBQ749; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25JBF743; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25IBA573; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBO985; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBB916; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24GBY148; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24EBO714; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 23LBH320; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBO017; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23JBA275; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23GBK387; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 1019532… (truncated, 10701 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K; 5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L; 6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B; 8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D; 9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C; 10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G; 11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A; 12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C; 13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F; 14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501; 15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

ALL 50 STATES
▸Full report

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBW804; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBX015; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBD094; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23IBQ501; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23FBO564; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23EBW686; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23DBO524; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22GBU281; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBR456; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBM213; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBN031; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22DBP331; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22MBA145; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22ABM907; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21KBE066; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21JBE527; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBH244; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE520; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE521; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21FBC630; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22IBU058; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22HBH306; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22GBQ912; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBT185; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBI063; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21IBM934; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21GBN290; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21DBG187; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21IBP593; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21HBA351; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBE684; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBA846; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21FBI072; Medline Kit Number/SKU DYNJ04592K: UDI/DI each 10193489215205, UDI/DI case 40193489215206, Lot Number : 23JLA230; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 22FBH340; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21CKA561; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21BKA591; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21AKB149; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23KBE105; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23JBH870; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23IBS256; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23HBW099; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23EBB384; Medline Kit Number/SKU DYNJ… (truncated, 13629 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 19, 2026

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

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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-0408-2026
Lot/product code:
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Recalling firm:
Amneal Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21KBM212; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21IBT678; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21GBF973; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21EBR775; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21DBH715; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21BBI962; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22HBO534; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBY086; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBG752; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22CBY116; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22ABS155; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 21LBF114; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23JBN926; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23FBE547; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23EBI633; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23DBA946; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23CBD209; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23ABH377.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

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▸Full report

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU CDS780056K: UDI/DI each 10888277941373, UDI/DI case 40888277941374, Lot Number: 21DBU610; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21KBG946; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21IBV394; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23IBO480; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23FBL915; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23EBP966; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23DBB223; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23CBO553; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23ABG956; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22KBD840; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22IBK666; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22HBZ276; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22GBK671; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22FBI951; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22EBE862; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22OBA987; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22BBC815; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21KBC808; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21HBM967; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21FBD640; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBN004; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBB965; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBU070; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBS617; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABT989; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABR939; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABE858; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBU114; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBB359; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBA010; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBP286; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBI821; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26BBJ914; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26ABU117; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25KBB123; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25JBJ200; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBX170; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBD249; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBV077; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBB825; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25BBS499; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25ABF429; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 24LBK961; Medline Kit Number/SKU CDS780208F: UDI/DI each 1019348… (truncated, 886852 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

ALL 50 STATES
▸Full report

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Number: 22GBV101; Medline Kit Number/SKU DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Number: 24IBG473; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25EBT656; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25DBN421; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25CBN640; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25BBL172; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25BBD651; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25ABA455; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 24KBO858; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 24JBH693; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 26ABH754; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25LBA242; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25HBT362; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25GBL430; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25FBT402.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

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

Recall #:
98552
Lot/product code:
Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025.
Recalling firm:
B Braun Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

Increased rate of not meeting quality requirements endotoxin results.

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

Recall #:
98607
Lot/product code:
Product ID: WSM0505. UDI-DI: 00386190001431. Lot Numbers: 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, 7593011.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 19, 2026

Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch

CGMP Deviations: use of an unapproved raw material

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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-0473-2026
Lot/product code:
Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027
Recalling firm:
Teva Pharmaceuticals USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069Q; 5. MINOR MB PACK-LF, Medline Kit Number/SKU DYNJ0429303L; 6. ENDOSCOPIC SKULL BASE PACK-LF, Medline Kit Number/SKU DYNJ0753948J; 7. RR-H&N FREEFLAP BLCKWELL PK-LF, Medline Kit Number/SKU DYNJ0785741K; 8. MINIMALLY INVASIVE PACK-LF, Medline Kit Number/SKU DYNJ0843063K; 9. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320K; 10. FREE FLAP BASIC SET-UP PK, Medline Kit Number/SKU DYNJ0991320M; 11. MLD PACK, Medline Kit Number/SKU DYNJ19521Q; 12. SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ34623C; 13. PMD PACK SURG CNTR-LF, Medline Kit Number/SKU DYNJ35305G; 14. LARYNGOSCOPY PACK, Medline Kit Number/SKU DYNJ37547D; 15. FUNCTIONAL SINUS ENDOSCOPY, Medline Kit Number/SKU DYNJ40406A; 16. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645C; 17. FREE FLAP B PACK, Medline Kit Number/SKU DYNJ40648G; 18. MINOR ENT PACK, Medline Kit Number/SKU DYNJ50808A; 19. SINUS ENDOSCOPY PACK-LF, Medline Kit Number/SKU DYNJ52062; 20. LAP PACK, Medline Kit Number/SKU DYNJ52116B; 21. LAP PACK, Medline Kit Number/SKU DYNJ52116C; 22. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719C; 23. ENDOSCOPY PK, Medline Kit Number/SKU DYNJ54719D; 24. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917I; 25. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917J; 26. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917K; 27. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917L; 28. FREE FLAP PACK, Medline Kit Number/SKU DYNJ56917N; 29. LARYNGOSCOPY WEST PACK, Medline Kit Number/SKU DYNJ58324A; 30. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558A; 31. CCH DECOMPRESSION PACK, Medline Kit Number/SKU DYNJ67558B; 32. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213; 33. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213D; 34. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213G; 35. EENT PACK, Medline Kit Number/SKU DYNJ68366B; 36. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447; 37. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447A; 38. FREE FLAP NO DRAPE PACK NTX, Medline Kit Number/SKU DYNJ68447B; 39. UNIVERSITY DISC PACK, Medline Kit Number/SKU DYNJ69824; 40. MAJOR PACK, Medline Kit Number/SKU DYNJ81325; 41. MAJOR PACK, Medline Kit Number/SKU DYNJ81325A; 42. MAJOR PACK, Medline Kit Number/SKU DYNJ81325B; 43. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751; 44. PLANO DIEP PACK, Medline Kit Number/SKU DYNJ81751A; 45. FLAP PACK, Medline Kit Number/SKU DYNJ85359; 46. ENDO PACK, Medline Kit Number/SKU DYNJ86125; 47. ENDO PACK, Medline Kit Number/SKU DYNJ86125A; 48. ENT PACK, Medline Kit Number/SKU DYNJ88448; 49. MAJOR BACK PACK, Medline Kit Number/SKU DYNJ88470; 50. UROLOGY DAVINCI, Medline Kit Number/SKU DYNJ901572O; 51. LARYNGOSCOPY/BRONCH, Medline Kit Number/SKU DYNJ902985F; 52. KIT FREE FLAP MOSES, Medline Kit Number/SKU DYNJ905366B; 53. FLAP, Medline Kit Number/SKU DYNJ907076C; 54. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165; 55. TRANSPHENOIDAL, Medline Kit Number/SKU DYNJ908165A; 56. ENDOSCOPY, Medline Kit Number/SKU DYNJ909512; 57. DIEP FLAP, Medline Kit Number/SKU DYNJ910120A; 58. DIEP BREAST, Medline Kit Number/SKU DYNJ911086; 59. WILLIAMS GENERAL, Medline Kit Number/SKU DYNJ940735F; 60. ROBOTIC LAP PROSTATE PACK CHS, Medline Kit Number/SKU DYNJT3101; 61. CUH FLAP ACCESSORY PACK, Medline Kit Number/SKU DYNJT3243.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

ALL 50 STATES
▸Full report

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25EDA675; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25CDA718; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25BDA328; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDB408; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDA607; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23HMH658; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23GMD341; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23EMB793; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23CMG372; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23BMI499; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22JMF967; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22EMC648; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22CMD889; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24EMH897; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24DMF264; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24BMJ904; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24AMH650; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23IME074; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23IMA416; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23EME302; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23DMH071; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23CMH752; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23LME133; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25LMB574; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25IMG534; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25EMJ878; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25DME997; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25CMI768; Medline Kit Number/SKU DYNJ0429303L: UDI/DI each 10195327587260, UDI/DI case 40195327587261, Lot Number: 24HMH265; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21KMD078; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21HME198; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21FMD014; Medline Kit Number/SKU DYNJ0785741K: UDI/DI each 10193489603576, UDI/DI case 40193489603577, Lot Number: 21CKA430; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23JDA179; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23HDC666; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23FDB421; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23EDA191; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23CDC020; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23BDA963; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23ADB394; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23LDA280; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21ILA211; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21HLA920; Med… (truncated, 54343 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 19, 2026

Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch

CGMP Deviations: use of an unapproved raw material

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▸Full report

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

Recall #:
D-0472-2026
Lot/product code:
Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.
Recalling firm:
Teva Pharmaceuticals USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M; 5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G; 6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C; 8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B; 9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F; 10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C; 11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B; 12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A; 13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223; 14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C; 15. ENS FREEFLAP PROCDURE - LF, Medline Kit Number/SKU DYNJ88249; 16. OPEN HEART A&B, Medline Kit Number/SKU DYNJ901203D; 17. NEURO ACD, Medline Kit Number/SKU DYNJ904549F; 18. KIT VP SHUNT RFD, Medline Kit Number/SKU DYNJ906303F; 19. ACDF-LF, Medline Kit Number/SKU DYNJ906681C; 20. ACDF-LF, Medline Kit Number/SKU DYNJ906681D; 21. ACDF-LF, Medline Kit Number/SKU DYNJ906681F; 22. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196B; 23. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196C; 24. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362F; 25. VP SHUNT, Medline Kit Number/SKU DYNJ909379; 26. VP SHUNT, Medline Kit Number/SKU DYNJ909379A.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

ALL 50 STATES
▸Full report

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA668; Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA240; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25IMG470; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMI158; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMC404; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ILA647; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23HLA953; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23GLA064; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ELA715; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22KLB111; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22GLB222; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA384; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA314; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22CLA246; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22BLA951; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ALB037; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA949; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA323; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21JLA776; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21ILA612; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21HLA761; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21CKA431; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21AKA070; Medline Kit Number/SKU DYNJ0750993M: UDI/DI each 10195327196721, UDI/DI case 40195327196722, Lot Number: 22HMA046; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMB856; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMA099; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24KMD499; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24IMH163; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24FMC456; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24EMF287; Medline Kit Number/SKU DYNJ0753933G: UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24DBR793; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23IMH609; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23FMI503; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23EMF428; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23CMG922; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB904; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB800; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23AMG570; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 22CLA968; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA678; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA280; Medline Kit Number/SKU DYNJ0888159I: UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23LMA074; Medline Kit Number/SKU DYNJ39861C: UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lo… (truncated, 18992 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

ALL 50 STATES
▸Full report

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23JMB165; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23CMH103; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMH200; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMB495; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KMH108; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KME285; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23KMJ648; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 26BME013; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25JMC725; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25IMA571; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25HMC497; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25FMG199; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25EMB523; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25DMF918; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25CMH298; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24LMA598; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24JMH963; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24IMC899; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24IMD398; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24EME289; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24CMG724; Medline Kit Number/SKU DYNJ0660040S: UDI/DI each 10198459674907, UDI/DI case 40198459674908, Lot Number: 26BMD088; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23JBW720; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23EBR729; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23DBC424; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23CBD133; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23BBA368; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22LBG835; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22KBV773; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22IBB948; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 24BBP259; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 24ABS878; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23LBH114; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24GBC544; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24FBL453; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24EBH347; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 25DBC120; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 25CBF213; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24KBU249; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24IBQ393; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24HBN580; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25JBA224; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25HBQ050; Medline Kit… (truncated, 6022 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 19, 2026

Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch

CGMP Deviations: use of an unapproved raw material

ALL 50 STATES
▸Full report

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

Recall #:
D-0474-2026
Lot/product code:
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Recalling firm:
Teva Pharmaceuticals USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C; 5. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555D.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

ALL 50 STATES
▸Full report

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22EMB486; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMI117; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB218; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 22CMB219; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA406; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21LMA805; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21JMF667; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21IMF752; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMG136; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21HMB278; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21GMD367; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21CKA503; Medline Kit Number/SKU DYNJ0751220P: UDI/DI each 10193489815122, UDI/DI case 40193489815123, Lot Number: 21AKA471; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23JBT331; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23IBL993; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23GBN118; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23FBQ324; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23EBO916; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23CBI861; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23BBE825; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 23ABD998; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22LBA177; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22IBJ001; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22FBY332; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22FBX502; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22EBE351; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 22ABO417; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21WBA306; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21KBG927; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21GBW059; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21GBW057; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21EBP877; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 21EBP891; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 26ABT067; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058.UDI/DI case 40193489846059, Lot Number: 25LBO620; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 25LBC010; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24KBR338; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24HBS302; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24HBR212; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24FBM377; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24EBC753; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24BBN421; Medline Kit Number/SKU DYNJ47568B: UDI/DI each 10193489846058, UDI/DI case 40193489846059, Lot Number: 24BBG081; Medline Kit Number/SKU DYNJ475… (truncated, 6693 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be not meeting quality requirements for endotoxin.

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

Recall #:
98664
Lot/product code:
Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23IME618; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23FMF542; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23DMA094; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23AMD730; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22GMB685; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMI233; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMC612; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 24AMA230; Medline Kit Number/SKU DYNJ51637D: UDI/DI each 10195327632106, UDI/DI case 40195327632107, Lot Number: 24GMI248; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JMK002; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JME739; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23IBJ883; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23EBO648; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23ABT378; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22KBG029; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22JBF057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22IBL935; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22FBD348; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22DBP280; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22BBB689; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22ABT749; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21KBX317; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBZ013; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBB969; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21IBB479; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21GBL057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21BBL823; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 26AMH608; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25LMB913; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25HMI678; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25GMK494; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25FMH605; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25DMA861; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25BMB215; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24JMJ380; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24FMD882; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24EMD977; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24DMF834; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24BMJ374; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23LMF318.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled March 18, 2026

Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

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

Recall #:
D-0478-2026
Lot/product code:
Lot: AH250162, Exp 8/31/2027
Recalling firm:
Amneal Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 18, 2026

Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.

Failed Impurities/Degradation Specifications: not meeting quality requirements at the time of testing i.e. 20th month stability testing.

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

Recall #:
Lot/product code:
Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.
Recalling firm:
ALEMBIC PHARMACEUTICALS, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 18, 2026

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results

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

Recall #:
98666
Lot/product code:
Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 17, 2026

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

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

Recall #:
98565
Lot/product code:
Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (lot): 71315US_00729_01_b00, 91076US_03269_00_b00, 72509US_01048_00_b00, 72839US_00065_00_b00, 39133US_11508_02_b00, 4202CA_00558_00_b00, 72630CA_00109_00_b00;
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 17, 2026

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

Failed Dissolution Specifications

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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-0444-2026
Lot/product code:
Lot# 8177156, Exp Date: 02/28/2027
Recalling firm:
Viatris, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 17, 2026

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

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

Recall #:
98565
Lot/product code:
Catalog Number/Art.: 027.4620; UDI-DI: 07630031713766; Order number (lot): 92465US_12039_00_b00 , 92465US_12040_00_b00 , 92465US_12047_00_b00 , 92465US_12048_00_b00 , 70959US_02227_00_b00 , 94021US_02348_00_b00, 70416US_07543_00_b00 , 91395US_01687_00_b00 , 91545US_03284_00_b00 , 91545US_03285_00_b00 , 71711US_00420_00_b00 , 91853US_06313_00_b00 , 72747US_00247_00_b00;
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)