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Recalls affecting Alaska

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

16,261 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
Class IIModerate risk
DrugRecalled March 20, 2026

Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01

Not guaranteed to be germ-free; blue Break-Off-Part could detach from the administration port

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-0440-2026
Lot/product code:
Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026.
Recalling firm:
Fagron Compounding Services
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 20, 2026

Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

ALL 50 STATES
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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-0459-2026
Lot/product code:
Lot # 20241030, Exp Date: 10/30/2026
Recalling firm:
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 20, 2026

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

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-0470-2026
Lot/product code:
Lot # 20240720, Exp Date: 07/20/2026.
Recalling firm:
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 20, 2026

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01

Not guaranteed to be germ-free; blue Break-Off-Part could detach from the administration port

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-0441-2026
Lot/product code:
Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026.
Recalling firm:
Fagron Compounding Services
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 19, 2026

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

CGMP Deviations: use of an unapproved raw material

ALL 50 STATES
▸Full report

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

Recall #:
D-0474-2026
Lot/product code:
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Recalling firm:
Teva Pharmaceuticals USA, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 19, 2026

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

CGMP Deviations: use of an unapproved raw material

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

Medline 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)
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)
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

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)
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

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

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.

ALL 50 STATES
▸Full report

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

Recall #:
98638
Lot/product code:
Model/Catalog Number: 11-1424 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

Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 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 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
Recalling firm:
United Orthopedic Corp.
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: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.

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 DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 22BBJ540; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21LBM539; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21IBX286; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21HBM832; Medline Kit Number/SKU DYNJ47491F: UDI/DI each10193489586725, UDI/DI case 40193489586726, Lot Number: 21KMD114; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 22FMI371; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 21IMD775; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23JBD782; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23HBY508; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23GBQ615; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBR984; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBD017; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23BBO048; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22JBI096; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22FBA057; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22CBA050; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21IBG464; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21GBJ471; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21EBA373; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21DBG514; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21ABD741; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23IBQ007; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23GBM279; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23EBT579; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23DBT199; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23CBP725; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23CBH452; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23ABR478; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22JBU430; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22IBM433; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22GBW568; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22EBG751; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22DBT428; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22DBE203; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22NBF066; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21KBZ291; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21IBL547; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21FBQ973; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21DBI879; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 26ABQ626; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25KBI185; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25JBK909; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25HBN871; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lo… (truncated, 6045 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. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555C; 5. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555D.

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

ALL 50 STATES
▸Full report

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

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

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

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

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

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

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 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.

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▸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, 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

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

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: 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

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.

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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

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, 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(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)