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Recalls affecting Illinois

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

17,357 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

View FDA’s announcement (opens in a new tab)
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

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

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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.

View FDA’s announcement (opens in a new tab)
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.

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)

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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

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

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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

View FDA’s announcement (opens in a new tab)
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 Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG06; 4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1.5", XR, LF, 10/PK, Medline SKU NEUROSPNG07; 5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG09; 6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75" X .75", XR, LF, 10/PK, Medline SKU NEUROSPNG11; 7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG13; 8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG14.

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:
1. NEUROSPNG02: UDI/DI each 10197344111572, UDI/DI case 20197344111579, ALL LOTS; 2. NEUROSPNG05: UDI/DI each 20080196286659, UDI/DI case 30080196286656, ALL LOTS; 3. NEUROSPNG06: UDI/DI each 20080196286505, UDI/DI case 30080196286502, ALL LOTS; 4. NEUROSPNG07: UDI/DI each 10080196286485, UDI/DI case 40080196286486, ALL LOTS; 5. NEUROSPNG09: UDI/DI each 20080196286536, UDI/DI case 30080196286533, ALL LOTS; 6. NEUROSPNG11: UDI/DI each 20080196286550, UDI/DI case 30080196286557, ALL LOTS; 7. NEUROSPNG13: UDI/DI each 10080196286577, UDI/DI case 40080196286578, ALL LOTS; 8. NEUROSPNG14: UDI/DI each 10080196286584, UDI/DI case 40080196286585, ALL LOTS.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231*; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

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

Recall #:
98615
Lot/product code:
The advisory population includes all models listed; however, the bounding differs by battery type: " All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population. " ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population. To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Brand Name: Leksell Vantage Arc System REF: 1053958

Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

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

Recall #:
98612
Lot/product code:
Lot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 00625 Right Z-Slide: UDI: 07340048304801/ Serial Numbers: 00001 00675
Recalling firm:
Elekta, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3 cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

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

Recall #:
98638
Lot/product code:
Model/Catalog Number: 11-1422 Lot Code: Lot: 101325, 101425 GTIN: 00888912005869
Recalling firm:
DJO, 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 (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.

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 BIOB110: UDI/DI each 10889942758043, UDI/DI case 40889942758044, Lot Number: 24HBM826; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23KBK939; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23JBD164; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23HBJ252; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23EBV328; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23DBD983; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBR624; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBM647; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBB199; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABR879; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABK516; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22KBO464; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22IBD725; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22FBH811; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22DBG358; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22CBS385; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22ABG822; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBK278; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBG921; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24BBM090; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24ABK179; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 26ABC519; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25JBY144; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25GBU677; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25FBK528; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25EBM571; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25DBA260; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25BBD145; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24KBA043; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBQ514; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBE904; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24HBT002; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABC251; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABA109; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22LBG189; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22JBH395; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22IBH148; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22IBH149; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22HBK033; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22FBP720; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22EBF677; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22EBE578; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21KBC814; Medline Kit Number/SKU CDS840490K: UDI/DI each 1019348943… (truncated, 668242 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

Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715

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:
UDI/DI EACH 10653160323068, UDI/DI case 40653160323069. Lot Numbers: 23JBY390, 23IBS518, 23FBW067, 23CBO045, 22HBC645, 22GBL079, 22DBP674, 22ABU694, 21IBM298, 21IBM495, 21GBB532, 21EBR576, 21CBL756, 21ABI942, 26ABG606, 25LBS129, 25IBK286, 25GBB222, 25DBH934, 25BBD132, 24LBO080, 24JBW176, 24HBT740, 24EBU727, 24ABW463.
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: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F

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:
UDI/DI each 10889942930883, UDI/DI case 40889942930884, Lot Numbers: 21GBA316, 21FBA411, 21DBI004, 21BBS142.
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

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133

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:
UDI/DI each 10884389388655, UDI/DI case 40884389388656, Lot Numbers: 22KDA794, 22JDB440, 22ADA361, 22ADA101, 21LDC095, 21LDA462, 21JDC613, 21JDB279, 21IDC073, 21FDA437, 21EDC004, 21EDC005, 21EDB599, 21DDA592, 21CDA826, 21BDA565.
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.

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 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: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B

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:
UDI/DI each 10889942214112, UDI/DI case 40889942214113, Lot Numbers: 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, 21BBL371.
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: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U

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:
UDI/DI each 10193489634594, UDI/DI case 40193489634595, Lot Number: 24ILA931
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: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG

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:
UDI/DI each 10198459237317, UDI/DI case 40198459237318: Lot Numbers: 25LBI308, 25JBH227, 25HBQ371, 25HBP069, 25GBQ494, 25FBM672, 25CBF603, 25BBG224, 25ABN190, 25ABN214.
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. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.

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 DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23JMD938; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23HMG766; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23DMD129; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 22KMD675; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23JBM687; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23EBD581; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23DBH247; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23CBS705; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23BBF189; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22JBF016; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22HBR972; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO928; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO407; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 24ABP390; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23LBN206; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23KLA222; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23JLA551; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23ILA611; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23HLA926; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23FLA515; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23LLA801.
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. 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.

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 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

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)
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.

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 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)
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

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-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)
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
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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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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
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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)
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UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

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-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.
Recalling firm:
B Braun Medical Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.

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: B3-3632M3705; UDI-DI Primary: 04046955348824; UDI-DI Unit: 04046955348817; All lots manufactured since 01AUG2025.
Recalling firm:
B Braun Medical Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.

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

Recall #:
98576
Lot/product code:
Model Number: 001015. Software Version Number R1.x. UDI Number: (01)00884838099272(21)153, (01)00884838099272(21)67, (01)00884838099272(21)675, (01)00884838085367(21)178, (01)00884838099272(21)112, (01)00884838085367(21)335, (01)00884838116801(21)345, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838099272(21)113, (01)00884838099272(21)121, (01)00884838116801(21)24, (01)00884838085367(21)170, (01)00884838099258(21)1150, (01)00884838116801(21)17, (01)00884838116801(21)25, (01)00884838059061(21)639, (01)00884838085268(21)856, (01)00884838116801(21)180, (01)00884838116801(21)227, (01)00884838099272(21)239, (01)00884838099272(21)105, (01)00884838116801(21)235, (01)00884838099272(21)678, (01)00884838054202(21)373, (01)00884838059115(21)290, (01)00884838085367(21)564, (01)00884838085268(21)716, (01)00884838085367(21)440, (01)00884838116801(21)226, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838059115(21)274, (01)00884838085367(21)247, (01)00884838085367(21)225, (01)00884838099272(21)592, (01)00884838099272(21)593, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099258(21)1234, (01)00884838085367(21)64, (01)00884838116801(21)20, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)153, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838116801(21)208, (01)00884838116801(21)205, (01)00884838116801(21)36, (01)00884838085367(21)85, (01)00884838085367(21)89, (01)00884838085367(21)320, (01)00884838099272(21)144, (01)00884838085367(21)109, (01)00884838085367(21)407, (01)00884838099272(21)779, (01)00884838116801(21)81, (01)00884838085367(21)505, (01)00884838059115(21)277, (01)00884838099272(21)559, (01)00884838085367(21)443, (01)00884838099272(21)98, (01)00884838099272(21)343, (01)00884838116801(21)147, (01)00884838116801(21)148, (01)00884838085367(21)104, (01)00884838099272(21)876, (01)00884838059115(21)168, (01)00884838099272(21)1021, (01)00884838099272(21)244, (01)00884838116801(21)31, (01)00884838099272(21)332, (01)00884838099272(21)781, (01)00884838099272(21)782, (01)00884838085367(21)524, (01)00884838099272(21)534, (01)00884838099272(21)129, (01)00884838099272(21)442, (01)00884838085367(21)400, (01)00884838059061(21)575, (01)00884838099272(21)189, (01)00884838099272(21)190, (01)00884838085367(21)510, (01)00884838116801(21)252, (01)00884838085367(21)110, (01)00884838099272(21)208, (01)00884838085367(21)73, (01)00884838085367(21)288, (01)00884838085268(21)281, (01)00884838116801(21)21, (01)00884838099272(21)400, (01)00884838085367(21)406, (01)00884838099272(21)326, (01)00884838085367(21)528, (01)00884838099272(21)323, (01)00884838116801(21)118, (01)00884838116801(21)50, (01)00884838085268(21)852, (01)00884838099258(21)101, (01)00884838085367(21)457, (01)00884838085367(21)470, (01)00884838085367(21)472, (01)00884838099272(21)778, (01)00884838116801(21)39, (01)00884838085268(21)704281, (01)00884838085367(21)319, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838085268(21)703418, (01)00884838116801(21)48, (01)00884838099272(21)482, (01)00884838116801(21)221, (01)00884838085367(21)150, (01)00884838099258(21)46, (01)00884838085367(21)172, (01)00884838085268(21)29, (01)00884838059115(21)61, (01)00884838099272(21)793, (01)00884838116801(21)68, (01)00884838085367(21)117, (01)00884838085268(21)930, (01)00884838099272(21)1017, (01)00884838085367(21)130, (01)00884838059115(21)264, (01)00884838099272(21)410, (01)00884838099272(21)508, (01)00884838059115(21)167, (01)00884838099272(21)419, (01)00884838085367(21)469, (01)00884838099272(21)472, (01)00884838059061(21)327, (01)00884838085268(21)21, (01)00884838116801(21)51, (01)00884838099272(21)383, (01)00884838085367(21)76, (01)00884838099272(21)59, (01)00884838099272(21)361, (01)00884838085367(21)477, (01)00884838099272(21)1002, (01)00884838085367(21)137, (01)00884838059061(21)580, (01)00884838116801(21)38, (01)00884838116801(21)22, (01)00884838099272(21)398, (01)00884838085367(21)107, (01)00884838116801(21)186, (01)00884838099272(21)75, (01)00884838054202(21)534, (01)00884838085268(21)255, (01)00884838116801(21)32, (01)00884838085367(21)282, (01)00884838099258(21)2557, (01)00884838099272(21)786, (01)00884838116801(21)276, (01)00884838099272(21)19, (01)00884838099272(21)1125, (01)00884838085367(21)487, (01)00884838099272(21)814, (01)00884838085367(21)213, (01)00884838099272(21)469, (01)00884838059115(21)172, (01)00884838099272(21)219, (01)00884838085367(21)82, (01)00884838099272(21)296, (01)00884838059061(21)607, (01)00884838099272(21)704, (01)00884838054226(21)102, (01)00884838059115(21)110, (01)00884838085367(21)485, (01)00884838085268(21)783, (01)00884838099258(21)2937, (01)00884838085367(21)276, (01)00884838085268(21)703565, (01)00884838116771(21)187, (01)00884838099272(21)693, (01)00884838099272(21)510, (01)00884838099272(21)882, (01)00884838099258(21)2852, (01)00884838099258(21)2931, (01)00884838099272(21)226, (01)00884838085367(21)559, (01)008… (truncated, 28497 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

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

Recall #:
98615
Lot/product code:
The advisory population includes all models listed; however, the bounding differs by battery type: " All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population. " ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population. To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup.
Recalling firm:
Boston Scientific Corporation
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