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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.

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

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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

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 medical procedure kits, containing Medline Neuro Sponges (102 in total)

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 CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23KBN711; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD593; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD781; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23DBF906; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22LBI985; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22KBC504; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22IBF741; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22FBX069; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22DBS948; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22CBX667; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21IBT137; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21HBG608; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 25GBV215; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 25GBA852; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24KBJ988; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24JBC528; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24IBV131; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24IBP386; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24GBA976; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24CBU492; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23KBW165; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 26ABK337; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 25JBE079; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 25HBV443; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25IBR604; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25HBR025; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25GBB389; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25FBC324; Medline Kit Number/SKU CDS983100D: UDI/DI each 10198459007934, UDI/DI case 40198459007935, Lot Number: 24KBH657; Medline Kit Number/SKU CDS983100D: UDI/DI each 10198459007934, UDI/DI case 40198459007935, Lot Number: 24GBN523; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23IBT936; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23HBA798; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23FBF767; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23DBD282; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 22KBJ790; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 22HBD313; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 24DBC806; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 24BBN518; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23LBL541; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23LBD588; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 23HDB332; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 23GDA495; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 23FDB617; Medline Kit Number/SKU CDS983493L: UDI/DI each 1019348… (truncated, 85030 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 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.

ALL 50 STATES
▸Full report

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 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

ALL 50 STATES
▸Full report

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

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I

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 10195327487546, UDI/DI case 40195327487547, Lot Numbers: 24KME456, 24HMJ900.
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.

ALL 50 STATES
▸Full report

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

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J; 5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B; 6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019; 7. ENT PACK, Medline Kit Number/SKU DYNJ86328; 8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263; 9. ENT PACK, Medline Kit Number/SKU DYNJ89675; 10. ENT PACK, Medline Kit Number/SKU DYNJ89675A; 11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.

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 DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25IMD003; Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25HMH643; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22GBS127; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22FBB472; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25FBE752; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25EBA260; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25DBG176; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25CBD819; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25BBA593; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 24KBJ163; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23KMI415; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMK023; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMB211; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23IMC591; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23HMG291; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23GMG136; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23FME285; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23EME227; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23CMD903; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMI915; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMH419; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24JMG571; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24HMF066; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24FMG130; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24CMI441; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24BMD229; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24AMH016; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26BMB944; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26AMJ197; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25KMC587; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25JMD275; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25IMC944; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25GMF811; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25FME706; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25EMA516; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25CME296; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 24LMD726; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 22HBH553; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 26BBF722; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25JBB835; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBO944; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBL998; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBH356; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 101… (truncated, 7577 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

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.

ALL 50 STATES
▸Full report

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
View official FDA record (opens in a new tab)
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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▸Full report

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
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.

ALL 50 STATES
▸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. 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.

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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 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)
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

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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-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

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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▸Full report

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

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH 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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▸Full report

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

Recall #:
98638
Lot/product code:
Model/Catalog Number: 11-1424 Lot Code: Lot: 110525 GTIN: 00888912017305
Recalling firm:
DJO, LLC
View official FDA record (opens in a new tab)
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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▸Full report

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.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE 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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▸Full report

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

Recall #:
98638
Lot/product code:
Model/Catalog Number: 11-0494 Lot Code: Lots: 146894, 146895, 146856, 146857 GTIN: 00888912003100
Recalling firm:
DJO, LLC
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.

ALL 50 STATES
▸Full report

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

Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

Increased rate of not meeting quality requirements endotoxin results.

ALL 50 STATES
▸Full report

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

Recall #:
98607
Lot/product code:
Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
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/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, 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.

ALL 50 STATES
▸Full report

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

Recall #:
98638
Lot/product code:
Model/Catalog Number: 11-9099 Lot Code: Lot: 110525 GTIN: 00888912000376
Recalling firm:
DJO, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

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

ALL 50 STATES
▸Full report

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

Recall #:
98552
Lot/product code:
Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025.
Recalling firm:
B Braun Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

ALL 50 STATES
▸Full report

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

Recall #:
99025
Lot/product code:
Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
Recalling firm:
United Orthopedic Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

Increased rate of not meeting quality requirements endotoxin results.

ALL 50 STATES
▸Full report

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

Recall #:
98607
Lot/product code:
Product ID: BMM0710. UDI-DI: 00386190001103. Lot Numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, 7593013.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

Increased rate of not meeting quality requirements endotoxin results.

ALL 50 STATES
▸Full report

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

Recall #:
98607
Lot/product code:
Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 7594284, 7593013.
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

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)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A

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 Numbers: 26ABM977, 25KBM387, 25IBG995, 25GBW704.
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).

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-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)