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Recalls affecting Alabama

Data last updated: September 11, 2026 at 1:08 PM UTC

16,908 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.

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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

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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

Recall #:
98642
Lot/product code:
1) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBQ267; 2) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBU924; 3) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216; 4) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBK913; 5) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBM302; 6) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23ABU170; 7) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBC364; 8) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBL439; 9) DYNDH1143C, UDI-DI: 10193489193336(each), 40193489193337(case), Lot Number: 22GBZ268; 10) DYNDH1873, UDI-DI: 10195327486464(each), 40195327486465(case), Lot Number: 23KBK476; 11) DYNDH1934, UDI-DI: 10195327519728(each), 40195327519729(case), Lot Number: 24FMF173; 12) DYNJ17489I, UDI-DI: 10195327224783(each), 40195327224784(case), Lot Number: 23CBL337; 13) DYNJ17558D, UDI-DI: 10195327504205(each), 40195327504206(case), Lot Number: 23JLB107; 14) DYNJ19063K, UDI-DI: 10888277828025(each), 40888277828026(case), Lot Number: 24DBL079; 15) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LME482; 16) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LMF497; 17) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 21JMC430; 18) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22BMH767; 19) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22EMD675; 20) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23AMC919; 21) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23DMD933; 22) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23GBI270; 23) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23HBR688; 24) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23KBD033; 25) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24ABL751; 26) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24DBK656; 27) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24EBQ366; 28) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24GBD309; 29) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 24IBT900; 30) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25EBA588; 31) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25HBK043; 32) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25IBA545; 33) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25JBA908; 34) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 22LBH614; 35) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23EBQ760; 36) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23FBT785; 37) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23LBA546; 38) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22JMG410; 39) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22LMF004; 40) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25CBM821; 41) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25DBP029; 42) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25EBU142; 43) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25GBO011; 44) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25HBG682
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431L; 6) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431N; 7) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 8) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 9) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 10) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 11) ROBOTIC PACK, Model Number: DYNJ04135B; 12) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 13) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 14) D&C PACK-LF, Model Number: DYNJ22567G; 15) D&C PACK-LF, Model Number: DYNJ22567I; 16) D&C PACK-LF, Model Number: DYNJ22567J; 17) D&C PACK-LF, Model Number: DYNJ22567K; 18) D&C HYSTEROSCOPY PACK, Model Number: DYNJ38805B; 19) D AND C, Model Number: DYNJ41272B; 20) D AND C, Model Number: DYNJ41272C; 21) OB PACK, Model Number: DYNJ42884; 22) D&C/GYN PACK, Model Number: DYNJ47713A; 23) PERI GYN PACK, Model Number: DYNJ55377D; 24) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 25) D&C PACK, Model Number: DYNJ67214D; 26) D&C PACK, Model Number: DYNJ67214F; 27) D&C PACK, Model Number: DYNJ67214G; 28) D&C PACK, Model Number: DYNJ67214I; 29) LITHOTOMY PACK, Model Number: DYNJ80765C; 30) GYN PACK, Model Number: DYNJ83475; 31) D AND C PACK, Model Number: DYNJ87468; 32) D&C-ASC, Model Number: DYNJ900465C; 33) D&C-ASC, Model Number: DYNJ900465D; 34) D&C-ASC, Model Number: DYNJ900465F; 35) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 36) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 37) D&C, Model Number: DYNJ906947C; 38) PACK PERI GYN DSMC, Model Number: DYNJT6424

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 3) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23BBG608; 4) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23DBM469; 5) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23FBA948; 6) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 7) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 8) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23IBQ647; 9) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23JBF512; 10) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABA205; 11) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABV349; 12) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABW239; 13) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24CBR704; 14) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24EBP485; 15) CDS985431N, UDI-DI: 10198459081590(each), 40198459081591(case), Lot Number: 24JBG321; 16) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 24LBH099; 17) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25ABT899; 18) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25CBE670; 19) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25EBE265; 20) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 21) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25HBO500; 22) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 23) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 24) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 25) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 26) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 27) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 28) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 29) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 30) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 31) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 32) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 33) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 34) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 35) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 36) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 37) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 38) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 39) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 40) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 41) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 42) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 43) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 44) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 45) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 46) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23EBS948; 47) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23HBP307; 48) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23JBY840; 49) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 50) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBM003; 51) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBT507; 52) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23LBM979; 53) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 24GBG491; 54) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 24KBD673; 55) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 25BBP569; 56) DYNJ04135B,… (truncated, 18470 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 January 7, 2026

Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYNJ15668R, UDI-DI: 10195327108502(each), 40195327108503(case), Lot Number: 23HMB037; 2) DYNJ42829B, UDI-DI: 10193489880151(each), 40193489880152(case), Lot Number: 22IBI084; 3) DYNJT3437, UDI-DI: 10198459325076(each), 40198459325077(case), Lot Number: 25FBK633
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 22KBD675; 2) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 23KBA331; 3) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24ABH890; 4) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24CBK339; 5) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24FBK537; 6) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBB895; 7) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBS071; 8) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25CBB549; 9) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25DBE771; 10) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBE995; 11) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBG142; 12) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBN454; 13) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25FBD161; 14) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25HBD027
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number:CVI3650; 6) LINE ATTIRE KIT, Model Number:DYKM2170; 7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274; 8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C; 9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A; 10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C; 11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B; 12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D; 13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F; 14) PLACENTA KIT, Model Number:DYNDA2322B; 15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A; 16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B; 17) PICC LINE TRAY, Model Number:DYNJ40500A; 18) VENOUS ACCESS PACK, Model Number:DYNJ42694C; 19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B; 20) PICC LINE, Model Number:DYNJ55546D; 21) PICC TRAY, Model Number:DYNJ63199A; 22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB; 23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB; 24) VEIN PACK, Model Number:DYNJ84239; 25) NEXTON PACK, Model Number:DYNJ88152; 26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 22) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25DDB786; 23) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25EDA196; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 31) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 32) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 33) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25ADB553; 34) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDA733; 35) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDB580; 36) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25HDA748; 37) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 38) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 39) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 40) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 41) DYKM2274, UDI-DI: 10198459278884(each), 40198459278885(case), Lot Number: 25HBK806; 42) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 43) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 44) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 45) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case).Lot Number: 23ABK335; 46) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 47) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 48) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 49) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 50) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 51) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 52) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 53) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 54) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 55) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 56) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Numbe… (truncated, 8610 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 January 7, 2026

Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYNJ0185290G, UDI-DI: 10193489378054(each), 40193489378055(case), Lot Number: 22LBQ336; 2) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21EBE777; 3) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21GBE802; 4) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21IBH675; 5) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBA253; 6) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBR457; 7) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22CBY841; 8) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBF686; 9) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBM263; 10) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBP453; 11) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22LBC300; 12) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22NBF780; 13) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23CBQ546; 14) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23EBH550; 15) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBG152; 16) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBL644; 17) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23HBG596; 18) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23KBI089; 19) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24BBN429; 20) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24GBT983; 21) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24HBP446
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020042290; 2) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020052290; 3) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020072290; 4) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020082690; 5) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2022030390; 6) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2022072590; 7) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2023062390; 8) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2023101290; 9) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2025031190; 10) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2025051290; 11) DT8670A, UDI-DI: 653160177473(each), 10653160177470(case), Lot Number: 2020051390
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21ABJ542; 2) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085; 3) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 21KLA631; 4) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22ALA713; 5) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22BLB059; 6) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22CLA049; 7) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS539; 8) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS540; 9) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21CBS043; 10) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21ABI996; 11) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21BBG092; 12) DYKMBNDL189A, UDI-DI: 10193489880823(each), 40193489880824(case), Lot Number: 21JLA521
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) CVI3780, UDI-DI: 10193489434866(each), 40193489434867(case), Lot Number: 23KBO637; 2) CVI3780, UDI-DI: 10193489434866(each), 40193489434867(case), Lot Number: 24ABC276; 3) DM1035, UDI-DI: 10193489442755(each), 40193489442756(case), Lot Number: 21BBN221; 4) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABJ003; 5) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABO838; 6) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21DBD662; 7) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21IBJ337; 8) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21JBJ253; 9) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22CBU342; 10) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22EBL039; 11) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBF510; 12) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBN333
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529O; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 11) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 12) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 13) C-SECTION PACK, Model Number: DYNJ23544F; 14) C-SECTION PACK, Model Number: DYNJ32632F; 15) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 16) C-SECTION PACK, Model Number: DYNJ35902F; 17) C-SECTION PACK-LF, Model Number: DYNJ38801F; 18) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 19) C-SECTION, Model Number: DYNJ41444F; 20) C-SECTION PACK, Model Number: DYNJ49224I; 21) C-SECTION PACK, Model Number: DYNJ49771A; 22) C-SECTION PACK, Model Number: DYNJ49771B; 23) C SECTION PACK-LF, Model Number: DYNJ52387I; 24) C-SECTION PACK, Model Number: DYNJ53528B; 25) C SECTION PACK-LF, Model Number: DYNJ55367A; 26) C-SECTION PACK, Model Number: DYNJ56523C; 27) C-SECTION PACK, Model Number: DYNJ59387L; 28) C-SECTION PACK, Model Number: DYNJ59387M; 29) C-SECTION PACK, Model Number: DYNJ59387N; 30) C-SECTION PACK, Model Number: DYNJ59387O; 31) C-SECTION PACK, Model Number: DYNJ59387P; 32) C-SECTION TRAY, Model Number: DYNJ62707B; 33) C-SECTION PACK, Model Number: DYNJ64549B; 34) C SECTION PACK, Model Number: DYNJ67347A; 35) C SECTION PACK, Model Number: DYNJ69778A; 36) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 37) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 38) PAD C-SECTION, Model Number: DYNJ902134C; 39) RICH C-SECTION, Model Number: DYNJ902182J; 40) C-SECTION, Model Number: DYNJ902938J; 41) C-SECTION PACK, Model Number: DYNJ904329D; 42) OB DELIVERY KIT, Model Number: DYNJ904453C; 43) C-SECTION, Model Number: DYNJ904697F; 44) C-SECTION, Model Number: DYNJ906255B; 45) KIT C SECTION, Model Number: DYNJ906966G; 46) C SECTION, Model Number: DYNJ907999A; 47) KIT C SECTION OR, Model Number: DYNJ908350C; 48) C-SECTION, Model Number: DYNJ909058; 49) C SECTION, Model Number: DYNJ909475A; 50) C-SECTION PACK, Model Number: DYNJ909507; 51) C-SECTION, Model Number: DYNJ910199; 52) C-SECTION, Model Number: DYNJ910199A; 53) C SECTION TRAY, Model Number: DYNJT3407; 54) C-SECTION BASIN PACK, Model Number: OBP211C; 55) TR-C SECTION PACK-LF, Model Number: PHS583549002B

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818; 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984; 3) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21WBA953; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23CMB465; 16) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23DMH505; 17) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23FMF781; 18) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23IMB944; 19) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23IME367; 20) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23JMD920; 21) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23JMI854; 22) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 23) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 24) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMI385; 25) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24BMG152; 26) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24CMJ610; 27) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 28) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMD740; 29) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 30) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 31) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 32) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 33) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 34) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25DMA214; 35) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25EMH398; 36) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 37) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25GMH469; 38) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 39) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 40) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 41) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 42) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 43) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 44) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 45) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 46) DYNJ35902F, UDI-DI: 10193489920109(each), 40193489920100(case), Lot Number: 23ABF399; 47) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 48) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 49) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 50) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 51) DYNJ49771A, UDI-DI: 10198459015717(each), 40198459015718(case), Lot Number: 24GBN350; 52) DYNJ49771B, UDI-DI: 10198459087776(each), 40198459087777(case), Lot Number: 24IBI305; 53) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 54) DYNJ53528B, UDI-DI: 10195327077303(each), 40195327077304(case), Lot Number: 23GBT514; 55) DYNJ55367A, UDI-DI: 10889942858903(each), 40889942858904(case), Lot Number: 24CBS240; 56) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430… (truncated, 14338 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 January 7, 2026

See complete list in RES, exceeds character limit. Medline Surgical Gowns

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525050165; 2) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070175; 3) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070223; 4) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100047; 5) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100144; 6) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100377; 7) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525020078; 8) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525040212; 9) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525060247; 10) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080205; 11) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080306; 12) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525090277; 13) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30522040040; 14) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100129; 15) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100146; 16) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525010225; 17) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120001; 18) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120083; 19) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010047; 20) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010092; 21) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524120004; 22) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050067; 23) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050068; 24) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070040; 25) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070088; 26) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070143; 27) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525070001; 28) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100019; 29) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100119; 30) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100124; 31) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100187; 32) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100026; 33) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100098; 34) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525020140; 35) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525020013; 36) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525040083; 37) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060001; 38) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060206; 39) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060207; 40) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080067; 41) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080138; 42) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080226; 43) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090032; 44) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090122; 45) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090257; 46) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110045; 47) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110109; 48) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110009; 49) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110013; 50) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110023; 51) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010003; 52) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010007; 53) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010008; 54) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010012; 55) DYNJ… (truncated, 321973 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 January 7, 2026

Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21CBV232; 2) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBB933; 3) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBE395; 4) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21JBF397; 5) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22ABE640; 6) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22EBK467; 7) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22KBA245; 8) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22LBR618; 9) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23CBE825; 10) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23EBC552; 11) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23HBP415; 12) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24BBV821; 13) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24DBK171; 14) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24IBD021; 15) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25DBK346; 16) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25FBN781; 17) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25HBG194; 18) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25LBC732
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 22JBH446; 2) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23ABA768; 3) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23BBS986; 4) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBN951; 5) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBT510; 6) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBV199; 7) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23GBA134; 8) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23JBH393; 9) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24BBH600; 10) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059; 11) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059A; 12) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24EMC989; 13) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24HME376; 14) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24JMG165; 15) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24KMH629; 16) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25AMD692; 17) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25EMB013; 18) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25FMI462; 19) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25HMH340; 20) DYNJ87157, UDI-DI: 10198459014482(each), 40198459014483(case), Lot Number: 24ILA361
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525030011; 2) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525050004; 3) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100025; 4) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100068; 5) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525020012; 6) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525040038; 7) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060015; 8) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060041; 9) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080004; 10) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080039; 11) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120082; 12) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120084; 13) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120097; 14) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520020055; 15) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030039; 16) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030064; 17) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030074; 18) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520050047; 19) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060018; 20) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060019; 21) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520070016; 22) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080003; 23) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080004; 24) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080059; 25) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520100068; 26) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120003; 27) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120004; 28) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521040001; 29) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050060; 30) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050064; 31) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050167; 32) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521060070; 33) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070019; 34) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070099; 35) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521080017; 36) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090001; 37) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090015; 38) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100005; 39) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100033; 40) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110009; 41) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110016; 42) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120009; 43) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120031; 44) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522010013; 45) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522020010; 46) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522030020; 47) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522040019; 48) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050012; 49) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050015; 50) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060019; 51) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060052; 52) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522070003; 53) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522080008; 54) DYNJP1050UG, UDI-DI: 10… (truncated, 7319 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 January 7, 2026

See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6) ROBOTIC-LF, Model Number: CDS984543D; 7) ROBOTIC-LF, Model Number: CDS984543F; 8) ROBOTIC-LF, Model Number: CDS984543G; 9) ROBOTIC-LF, Model Number: CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 15) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 16) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 17) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 18) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 19) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 20) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91;

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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▸Full report

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

Recall #:
98642
Lot/product code:
1) CDS981504G, UDI-DI: 10195327157968(each), 40195327157969(case), Lot Number: 25BDB744; 2) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23EBE997; 3) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23GBL921; 4) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23GBO574; 5) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23IBC607; 6) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23JBQ095; 7) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240; 8) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21EBA117; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21GBI171; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21HBN807; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21IBM804; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22BBL450; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22FBV462; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22GBP114; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22HBV491; 18) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22JBC547; 19) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22KBD152; 20) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22OBM422; 21) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23ABC549; 22) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBN644; 23) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBX440; 24) CDS984543D, UDI-DI: 10195327072322(each), 40195327072323(case), Lot Number: 22CBC587; 25) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22GBD616; 26) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMB259; 27) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMG671; 28) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22JMA223; 29) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22KMD619; 30) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22OBL925; 31) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24AMJ461; 32) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23BMD680; 33) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23CMC582; 34) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23DMA508; 35) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23EMI460; 36) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23FMI171; 37) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMF425; 38) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMH282; 39) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23IMA629; 40) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23JMC376; 41) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23LMA864; 42) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24BMH483; 43) CDS984543I, UDI-DI: 10195327637071(each), 40195327637072(case), Lot Number: 24CMH050; 44) CDS984860F, UDI-DI: 10193489261974(each), 40193489261975(case), Lot Number: 21ADB205; 45) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH282; 46) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH547; 47) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21DBV243; 48) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25DBN805; 49) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25FBS108; 50) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25HBS386; 51) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25LBN225; 52) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21ABI962; 53) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21BBG514; 54) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21EBA097; 55) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21GBP406; 56) DYKMBNDL100, UDI-DI: 10193489477955(each), 401934894779… (truncated, 35147 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 January 7, 2026

Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98642
Lot/product code:
1) DYNDA2941A, UDI-DI: 10195327331795(each), 40195327331796(case), Lot Number: 23BMB940; 2) DYNDA2941A, UDI-DI: 10195327331795(each), 40195327331796(case), Lot Number: 23FMF503; 3) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23CBG610; 4) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23FBF248; 5) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23LBR075; 6) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24CBH626; 7) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24DBT832; 8) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23KBM234; 9) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23KBO757; 10) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 23LBQ441; 11) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 24BBG312; 12) DYNJ908337A, UDI-DI: 10195327524814(each), 40195327524815(case), Lot Number: 24EBM141; 13) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24HBW695; 14) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24IBN719; 15) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 24KBK455; 16) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25ABG235; 17) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25BBO546; 18) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25DBG687; 19) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25DBQ261; 20) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25FBF535; 21) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25FBW469; 22) DYNJ908337C, UDI-DI: 10198459085925(each), 40198459085926(case), Lot Number: 25GBV755
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 00085412917696, All lots including and manufactured after 24F0085
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414090005, All lots including and manufactured after 24F0100CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 6, 2026

AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

CGMP deviations.

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-0260-2026
Lot/product code:
Lot #: 239066, Exp. Date 1/24/2027; 378106, Exp. Date 3/8/2026; 379202, Exp. Date 3/29/2026; 379750, Exp. Date 4/24/2026; 380983, Exp. Date 5/24/2026; 382901, Exp. Date 7/11/2026; 384682, Exp. Date 8/16/2026; 386189, Exp. Date 9/20/2026; 387559, Exp. Date 10/11/2026; 388381, Exp. Date 11/2/2026; 398066, Exp. Date 1/24/2027; 389477, Exp. Date 2/21/2027; 392491, Exp. Date 3/13/2027; 393724, Exp. Date 4/3/2027, 394683, Exp. Date 4/29/2027; 395094, Exp. Date 5/29/2027; 395231, Exp. Date 6/18/2027; 395368, Exp. Date 7/17/2027, 397971, Exp. Date 11/8/2027; 398930, Exp. Date 8/28/2027; 399204, Exp. Date 9/25/2027; 400300, Exp. Date 10/16/2027; 403177, Exp. Date 11/8/2027; 403314, Exp. Date 11/25/2027; 405095, Exp. Date 1/24/2028; 406328, Exp. Date 2/14/2028; 407700, Exp. Date 4/3/2028; 407974, Exp. Date 4/17/2028; ; 410166, Exp. Date 6/13/2028; 410988, Exp. Date 7/1/2028.
Recalling firm:
Encon Safety Products Co
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414069254, All lots including and manufactured after 24G0034CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414111038, All lots including and manufactured after 24J0106
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414069315, All lots including and manufactured after 24F0094CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 00085412954073, All lots including and manufactured after 24G0072
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)