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Recalls affecting Alaska

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

16,296 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline kit SKU DYNJ0785864R, UDI/DI 10195327656454 (EA) 40195327656455 (CA), Lot Number 25HMB184; Medline kit SKU DYNJ0792607R, UDI/DI 10198459503023 (EA) 40198459503024 (CA). Lot number 25JMH400.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100; Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBL296; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBN030; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25HLA445; Medline SKU DYKM1025D, UDI/DI 10195327482893 (EA) 40195327482894 (CS), Lot Number 25HMA140; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IBI197; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IBL774; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IMG620; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IMH657; Medline SKU PHS972012D, UDI/DI 10193489571875 (EA) 40193489571876 (CS), Lot Number 25IMH924; Medline SKU DYNJ905557B, UDI/DI 10193489468243 (EA) 40193489468244 (CS), Lot Number 25JBH529; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25JBO555; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25JLA937; Medline SKU CDS984355K, UDI/DI 10198459258848 (EA) 40198459258849 (CS), Lot Number 25KBB119; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
UDI/DI 10889942695911 (EA) 40889942695912 (CA), Lot Numbers: 25JMC398
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit SKU DYKS1192C; 9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B; 10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B; 11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248; 12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249; 13) PRE OP KIT, Medline kit SKU DYKS1274A; 14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324; 15) PRE OP KIT, Medline kit SKU DYKS1376; 16) PTC KIT, Medline kit SKU DYNDH1161A; 17) DR BROWN BODY, Medline kit SKU DYNJ910487.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB125; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB400; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25JDB835; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA036; Medline kit SKU ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25KDA248; Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25IDA545; Medline kit SKU ACC010416B, UDI/DI 10195327223670 (EA) 40195327223671 (CS), Lot number 25JDB867; Medline kit SKU ACC010525C, UDI/DI 10198459027765 (EA) 40198459027766 (CS), Lot number 25KDA768; Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25HDB656; Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25IDA638; Medline kit SKU ACC010688, UDI/DI 10195327432713 (EA) 40195327432714 (CS), Lot number 25JDA666; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25HDA878; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA087; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25IDA817; Medline kit SKU ACC010770, UDI/DI 10195327576998 (EA) 40195327576999 (CS), Lot number 25JDB317; Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25IBL412; Medline kit SKU DYKM1279C, UDI/DI 10889942519583 (EA) 40889942519584 (CS), Lot number 25KBK165; Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25IMD671; Medline kit SKU DYKS1179, UDI/DI 10193489711981 (EA) 40193489711982 (CS), Lot number 25JMG868; Medline kit SKU DYKS1192C, UDI/DI 10193489849707 (EA) 40193489849708 (CS), Lot number 25KME757; Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25HBF059; Medline kit SKU DYKS1199B, UDI/DI 10193489403831 (EA) 40193489403832 (CS), Lot number 25JBU391; Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25IBT744; Medline kit SKU DYKS1200B, UDI/DI 10193489235425 (EA) 40193489235426 (CS), Lot number 25KBG976; Medline kit SKU DYKS1248, UDI/DI 10193489305708 (EA) 40193489305709 (CS), Lot number 25JBS281; Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBJ008; Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25HBV936; Medline kit SKU DYKS1249, UDI/DI 10193489305715 (EA) 40193489305716 (CS), Lot number 25IBB540; Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25HBF086; Medline kit SKU DYKS1274A, UDI/DI 10195327058890 (EA) 40195327058891 (CS), Lot number 25IBF923; Medline kit SKU DYKS1324, UDI/DI 10193489969962 (EA) 40193489969963 (CS), Lot number 25IBR790; Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25HBF087; Medline kit SKU DYKS1376, UDI/DI 10195327216498 (EA) 40195327216499 (CS), Lot number 25IBS865; Medline kit SKU DYNDH1161A, UDI/DI 10889942731299 (EA) 40889942731290 (CS), Lot number 25HBG750; Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25GMK728; Medline kit SKU DYNJ910487, UDI/DI 10198459004841 (EA) 40198459004842 (CS), Lot number 25HMI417;
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25JBB147; Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25KBL305; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25HBT834; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25IBJ757; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25JBJ557; Medline kit SKU DYKS1372C, UDI/DI 10195327373504 (EA) 40195327373505 (CS), Lot Number 25JLA480; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25HBI335; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25IBE523; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25JBM702; Medline kit SKU DYNDV2464A, UDI/DI 10195327065911 (EA) 40195327065912 (CS), Lot Number 25IBV942.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Cook Medical identified that products supplied in the affected device lots may have been manufactured not meeting quality requirements. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

ALL 50 STATES
▸Full report

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

Recall #:
98027
Lot/product code:
1) Reference Part Number RTPS-100: Order Number G06541, UDI (01)00827002065413(17)280722(10)16705779, Lot Number 16705779; 2) Reference Part Number RTPS-100-10.0: Order Number G29769, UDI (01)00827002297692(17)280624(10)16659044, Lot Number 16659044
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Cook Medical identified that products supplied in the affected device lots may have been manufactured not meeting quality requirements. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

ALL 50 STATES
▸Full report

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

Recall #:
98027
Lot/product code:
Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

ALL 50 STATES
▸Full report

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

Recall #:
98070
Lot/product code:
A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602
Recalling firm:
Beckman Coulter, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

ALL 50 STATES
▸Full report

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

Recall #:
98070
Lot/product code:
973100: UDI 15099590265373 (Chaska) and 16954701000412 (Suzhou); A71456: UDI 15099590369194; A71457: UDI 15099590369231; A25288: UDI 15099590194819
Recalling firm:
Beckman Coulter, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
UDI/DI 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
UDI/DI 10193489587869 (EA) 40193489587860 (CS), Lot Number 25HBQ850
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 26, 2025

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

Weaker than it should be product:not meeting quality requirements assay results observed during long term stability testing.

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▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0237-2026
Lot/product code:
Lot #: A250020, Exp Date 06/30/2026
Recalling firm:
SOMERSET THERAPEUTICS LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 26, 2025

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0223-2026
Lot/product code:
Lot 1312405; Exp 09/28/2027
Recalling firm:
Winder Laboratories, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ38935

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
UDI/DI 10884389725092 (EA) 40884389725093 (CS), Lot number 25IBC144
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 25, 2025

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

Butyrate tube cracks during actuation, rendering product unusable.

ALL 50 STATES
▸Full report

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

Recall #:
98035
Lot/product code:
Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Recalling firm:
Ferndale Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 24, 2025

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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▸Full report

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

Recall #:
D-0215-2026
Lot/product code:
Lot #: 240947C, 240962C, Exp. Date 04/2027
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 24, 2025

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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-0216-2026
Lot/product code:
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

AKALAZCACOFLGAIAIDILINKSLAMAMDMIMNMOMSMTNCNENJNVNYOHOKPASCSDTXUTVAWIWVWY
▸Full report

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

Recall #:
98049
Lot/product code:
Model Number: 72081-01 UDI-DI Code: 00357599818005 Product with Expiry Date 12/31/2025 Kit Lot Numbers: T60003054 Pack Serial Numbers: 0HYCDDYCC 0HYCDDYC1 0HYCDDY3A 0HYCDDYCE 0HYCDDY32 0HYCDDY3D 0HYCDDYC2 0HYCDDY34 0HYCDDY3F 0JAET01AW 0HYCDDY33 0HYCDDY3H 0HYCDDY3E 0HYCDDY35 0HYCDDYKL 0HYCDDYKK 0JAET02A8 0JAET029Z 0HYCDDYK9 0JAET02A7 0JAET02AA 0JAET029Y 0JAET02A9 0HYCDDYKP 0JAET02A0 0HYCDDYKN 0HYCDDYKR 0JAET02A2 0HYCDDYKD 0HYCDDYKQ 0JAET02AE 0JAET02A4 0HYCDDYKF 0JAET02AD 0JAET02AG 0JAET02A6 0JAET02A3 0JAET02AF 0HYCDDY2N 0HYCDDY2C 0JAET02A5 0HYCDDY2M 0JAET01AZ 0JAET01AV 0HYCDDY2A 0HYCDDY2P 0JAET01AX 0JAET01L3 0JAET01AU 0JAET01C0 0JAET01K3 0JAET01JT 0JAET01C1 0HYCDDY2U 0HYCDDY2H 0JAET01L2 0HYCDDY2T 0JAET01L1 0JAET01KU 0HYCDDY2G 0JAET019H 0JAET01KT 0JAET01KY 0JAET01KV 0JAET01L0 0JAET01JY 0JAET01KZ 0JAET01KR 0HYCDDZKC 0HYCDDZKN 0JAET039T 0HYCDDZKA 0HYCDDZKE 0HYCDDZKQ 0HYCDDZKM 0HYCDDZKD 0JAET03AL 0JAET03AX 0HYCDDZKP 0JAET0E3M 0JAET0E3A 0JAET0E3L 0JAET0E39 0JAET0E96 0JAET0E97 0JAET0E9J 0JAET0E98 0JAET0E9K 0JAET0E99 0JAET0E9L 0JAET0E9A 0JAET0E9M 0JAET0A33 0JAET0A2M 0JAET0EA2 0JAET0EAD 0JAET0EA3 0JAET0EAE 0JAET0E9C 0JAET0E9N 0JAET0E9D 0JAET0E9P 0JAET0E9E 0JAET0E9Q 0JAET0E9F 0JAET0E9R 0JAET0E9G 0JAET0A2Y 0JAET0A2T 0JAET09JW 0HU6K8LCE 0HU6K8LC4 0HU6K8LC5 0HU6K8LC6 0HU6K8LCJ 0JAET09RA 0JAET09JQ 0HU6K8LC8 0HU6K8LC9 0HU6K8LCC 0HU6K8LCN 0HU6K8LCD 0HU6K8LCP 0JAET09RG 0JAET0E2A 0JAET0E29 0JAET0E2F 0JAET0E2K 0JAET0E2J 0JAET0E24 0JAET0E2H 0JAET0E23 0JAET09T8 0JAET09RZ 0JAET09T9 0JAET09T0 0JAET09TA 0JAET09T1 0JAET09TC 0JAET09TD 0JAET0E38 0JAET09HZ 0JAET0E28 0JAET0E2D 0JAET0E27 0JAET0E2C 0JAET04RR 0JAET04TA 0JAET04T2 0JAET04RZ 0JAET04T9 0HYCDE1JF 0JAET04T1 0JAET04TC 0HYCDE1JU 0HYCDE1J9 0JAET04T3 0JAET04TG 0HYCDE1JN 0HYCDE1JE 0HYCDE197 0HYCDE1JM 0HYCDE1A3 0HYCDE19V 0HYCDE1AF 0HYCDE1A4 0HYCDE19G 0HYCDE19T 0HYCDE1AD 0HYCDE1A2 0HYCDE19E 0HYCDE19N 0HYCDE19U 0HYCDE19F 0JAET04JU 0HYCDE19R 0HYCDE19D 0JAET04JG 0JAET04JR 0JAET04JV 0JAET04JH 0JAET04JE 0JAET04J6 0JAET04JT 0JAET04JF 0JAET04HW 0JAET04J4 0JAET04JD 0JAET04HU 0JAET04JN 0JAET04J5 0JAET04HV 0JAET04JA 0JAET04JL 0JAET04JP 0JAET04JC 0JAET04J1 0JAET04JM 0JAET04J9 0JAET04HQ 0JAET04HZ 0JAET04J7 0JAET04RQ 0JAET041P 0JAET04J0 0JAET04RP 0JAET041N 0JAET041R 0JAET041Q 0JAET041V 0JAET041L 0JAET0418 0JAET041T 0JAET041M 0JAET040Y 0JAET0416 0JAET040Z 0JAET04KV 0JAET04K4 0JAET04KL 0JAET04KW 0JAET04JY 0JAET04K2 0JAET04KH 0JAET04JZ 0HYCDDZKF 0JAET039N 0JAET039M 0HYCDDZKH 0HYCDDZKV 0JAET039Y 0HYCDDZKK 0HYCDDZKT 0HYCDDZKJ 0JAET03AR 0JAET03C2 0HYCDDZKW 0HYCDDZKL 0JAET03AZ 0HYCDDZKZ 0JAET03AM 0JAET03AQ 0JAET03C1 0JAET03AP 0HYCDDZV9 0HYCDDZUY 0JAET03C0 0HYCDDZVA 0HYCDDZUW 0HYCDDZV6 0HYCDDZUZ 0HYCDDZV8 0JAET03AU 0JAET03C4 0HYCDDZV7 0JAET03AT 0JAET03AW 0JAET03C6 0JAET03C3 0JAET03AV 0HYCDDZV4 0HYCDDZUT 0JAET03C5 0HYCDDZV5 0HYCDDZUQ 0HYCDDZV0 0HYCDDZV3 0JAET03UY 0HYCDE03C 0JAET03UX 0JAET03V8 0JAET03UA 0JAET03V6 0JAET03UZ 0HYCDE035 0JAET03V0 0HYCDE033 0JAET03V1 0JAET03V9 0HYCDE036 0JAET03A1 0JAET03AH 0JAET03VC 0JAET03A0 0JAET03A3 0JAET03AK 0JAET03AG 0JAET03A2 0JAET039A 0JAET039P 0JAET03AJ 0JAET03A4 0JAET039E 0JAET039R 0JAET031P 0JAET039C 0JAET03A6 0JAET03AC 0JAET039Q 0JAET03A5 0JAET03A8 0JAET03AE 0JAET03AA 0JAET03A7 0JAET0AAR 0JAET0AAH 0JAET0AAJ 0JAET0AAV 0JAET0AAK 0JAET0AAW 0JAET0EHH 0JAET0EH6 0JAET0EHA 0JAET0EH9 0JAET0EHK 0JAET0EH8 0JAET0EHJ 0JAET0EH7 0JAET0ERD 0JAET0ER3 0JAET0ERE 0JAET0ER4 0JAET0ERF 0JAET0ER5 0JAET0ERG 0JAET0EHG 0JAET0EH4 0JAET0EHE 0JAET0EH3 0JAET0EHD 0JAET0EH2 0JAET0ERK 0JAET0ER8 0JAET0ER7 0JAET0ERA 0JAET0ERM 0JAET0ERJ 0JAET0ER9 0JAET0ERL 0JAET09T3 0JAET09TE 0JAET09T5 0JAET09TG 0JAET09T6 0JAET09TH 0JAET09T7 0JAET09TJ 0JAET0E33 0JAET0E2Y 0JAET0E2X 0JAET0E2W 0JAET0E35 0JAET0E2V 0JAET0E34 0JAET0E2U 0JAET09TW 0JAET09TL 0JAET09TX 0JAET09TY 0JAET09TN 0JAET0E2T 0JAET0E32 0JAET0E2R 0JAET0E31 0JAET0E2Q 0JAET0E30 0JAET0E2P 0JAET0E2Z 0JAET0A3P 0JAET0A3D 0JAET0A3N 0JAET0A3C 0JAET0A3M 0JAET0A3A 0JAET0A3L 0JAET09VN 0JAET09VZ 0JAET09VP 0JAET09W0 0JAET09VQ 0JAET09W1 0JAET0A3K 0JAET0A38 0JAET0A3J 0JAET0A37 0JAET0A3H 0JAET0A36 0JAET0A35 0JAET0A3F 0JAET0A39 0JAET09W2 0JAET0A41 0JAET09W3 0JAET0A40 0JAET09W4 0JAET0E89 0JAET09W6 0JAET0E9U 0JAET0A3R 0JAET0E9W 0JAET0EA6 0JAET0A46 0JAET0A3W 0JAET0A45 0JAET0A3V 0JAET0A44 0JAET0A3U 0JAET0A43 0JAET0A3T 0JAET0E9Z 0JAET0EA9 0JAET0EA0 0JAET0EAA 0JAET0EA1 0JAET0EAC 0JAET0E9X 0JAET0EA7 0JAET0E9Y 0JAET04JX 0JAET04K5 0JAET04K3 0HYCDE12Z 0HYCDE136 0HYCDE138 0JAET04K6 0JAET04KC 0HYCDE1C4 0HYCDE1C7 0HYCDE1C6 0HYCDE1C5 0HYCDE1C2 0HYCDE1AM 0HYCDE1C8 0HYCDE1C3 0HYCDE1AA 0JAET04K0 0HYCDE1AP 0HYCDE1AC 0HYCDE1AU 0HYCDE1AT 0JAET04K1 0JAET04JW 0HYCDE1AZ 0HYCDE1AQ 0HYCDE1C1 0HYCDE1C0 0HYCDE1AV 0HYCDE1AG 0HYCDE1AY 0HYCDE1A5 0HYCDE1AK 0HYCDE1AH 0HYCDE1A6 0HYCDE1A8 0HYCDE1A1 0HYCDE1AL 0HYCDE1A9 0HYCDE19M 0HYCDE19Y 0HYCDE1AJ 0HYCDE1A7 0HYCDE19K 0HYCDE19W 0HYCDE19Z 0HYCDE19L 0HYCDE19H 0HYCDE1AE 0HYCDE19X 0HYCDE19J 0JAET04C2 0JAET04C5 0JAET03UG 0JAET03UQ 0JAET03UL 0JAET03UN 0JAET03UP 0HYCDE0A5 0JAET03UK 0HYCDE0AH 0HYCDE0AE 0HYCDE0A3 0HYCDE0A6 0HYCDE0AF 0JAET042Z 0JAET0434 0HYCDE0A4 0HYCD… (truncated, 5255633 characters total — see the official FDA record for the full value)
Recalling firm:
Abbott Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

AKALAZCACOFLGAIAIDILINKSLAMAMDMIMNMOMSMTNCNENJNVNYOHOKPASCSDTXUTVAWIWVWY
▸Full report

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

Recall #:
98049
Lot/product code:
Model Number: 78769-01 UDI-DI Code: 00357599843014 Product Expiry Date: 01/31/2026 Kit Pack Lot Number: T60003166 Pack Serial Numbers: 0HPCMWH9Y 0HPCMWHAV 0HPCMWHA9 0HPCMWHA0 0HPCMWHAK 0HPCMWHAR 0HPCMWHAU 0HPCMWHAJ 0HPCMWHAG 0J8A08TUA 0HPCMWHAQ 0HPCMWHAF 0J8A08TTZ 0J8A08TUD 0HPCMWHAT 0J8A08TTY 0J8A08TU1 0HPCMWHAZ 0J8A08TUC 0J8A08TU0 0HPCMWHC9 0HPCMWHAX 0J8A08TUE 0J8A08TU2 0HPCMWHAM 0J8A08TUG 0HPCMWHAW 0HPCMWHAL 0J8A08TU5 0J8A08TUJ 0HPCMWHAY 0J8A08TU3 0J8A08TU8 0HPCMWHC4 0J8A08TUH 0J8A08TU7 0HPCMWHL8 0J8A08TW4 0HPCMWHLL 0HPCMWHL9 0J8A08U3T 0J8A08U45 0J8A08TW3 0J8A08U3U 0J8A08U3Q 0J8A08U3N 0J8A08TW5 0J8A08U3R 0J8A08U3C 0J8A08U3L 0J8A08TW1 0J8A08U39 0J8A08U31 0J8A08U3M 0J8A08U3A 0J8A08U2Q 0J8A08U2Z 0J8A08U3K 0J8A08U2N 0J8A08U3H 0J8A08U30 0J8A08U2P 0J8A08U36 0J8A08U43 0J8A08TV2 0J8A08U34 0J8A08U2W 0J8A08U3G 0J8A08U35 0J8A08U2K 0J8A08U2U 0J8A08U3E 0J8A08U38 0J8A08U2H 0J8A08U2L 0J8A08U2V 0J8A08U2J 0HPCMWHKW 0J8A08U2Y 0J8A08U2X 0HPCMWHL5 0HPCMWHKU 0J8A18G45 0J8A18G29 0J8A18G20 0J8A18G3W 0J8A18G3Y 0J8A18G2C 0J8A18G22 0J8A18G1Z 0J8A18G2A 0J8A18FWA 0J8A18G40 0J8A18G21 0HPD38KT2 0HPD38KTF 0HPD38KTG 0HPD38KTR 0HPD38KTH 0HPD38KTT 0HPD38KTJ 0JH6L4FC0 0JH6L4FAP 0JH6L4FC1 0JH6L4FAQ 0HPD38KRW 0JH6L4FAR 0HPD38KT8 0HPD38KT7 0HPD38KTL 0HPD38KTK 0HPD38KTM 0HPD38KTA 0HPD38KTN 0HPD38KTC 0HPD38KTP 0HPD38KTD 0JH6L4FAV 0JH6L4FC6 0JH6L4FAW 0JH6L4FC2 0JH6L4FAX 0JH6L4FC3 0HPD38KR5 0J8A18G1R 0J8A18G1K 0HPD38KRK 0J8A18G1T 0J8A18G1V 0J8A18G1H 0J8A18G1L 0J8A18G1W 0J8A18G82 0J8A18G8R 0J8A18G1J 0J8A18G1U 0J8A18G85 0J8A18G8U 0J8A18G8Q 0J8A18G84 0J8A18G88 0J8A18G1E 0J8A18G1P 0J8A18G1C 0J8A18G1F 0J8A18G1Q 0JH6L4FAT 0JH6L4FC4 0JH6L4FAU 0HPD38KUV 0HPD38KUJ 0HPD38KUW 0HPD38KUX 0HPD38KUL 0HPD38KUY 0HPD38KUM 0HPD38KUZ 0HPD38KUN 0JH6L4FC7 0J8A18GLT 0JH6L4FC8 0JH6L4Q11 0JH6L4Q0Y 0JH6L4Q19 0JH6L4Q0Z 0JAEYKEHA 0JAEYKEHQ 0JAEYKEHN 0JAEYKEHC 0JAEYKEHE 0JAEYKEH5 0JAEYKEHR 0JAEYKEHF 0JAEYKERA 0JAEYKEH3 0JAEYKEHP 0JAEYKEHD 0JAEYKERD 0JAEYKER3 0JAEYKEH4 0JAEYKERC 0JAEYKERF 0JAEYKEHK 0JAEYKER2 0JAEYKERE 0JAEYKEH8 0JAEYKER4 0JAEYKEHL 0JAEYKEH9 0JAEYKERG 0JAEYKER6 0JAEYKEH6 0JAEYKERJ 0JAEYKER9 0JAEYKERH 0JAEYKERL 0JH6L4Q0V 0JAEYKER8 0JAEYKERK 0JH6L4Q0J 0JH6L4Q0T 0JH6L4Q0X 0JH6L4Q0K 0JH6L4Q0G 0JAEYKET8 0JH6L4Q0U 0JH6L4Q0H 0JAEYKETK 0JAEYKETA 0JH6L4Q0R 0JH6L4Q0F 0JAEYKETM 0JH6L4Q0P 0JAEYKET9 0JAEYKETL 0JH6L4Q0D 0JH6L4Q0M 0JH6L4Q0Q 0JH6L4Q0E 0JH6L4Q0A 0JAEYKETE 0JH6L4Q0N 0JH6L4Q0C 0JAEYKETQ 0JH6L4Q0L 0JH6L4Q09 0JAEYKETT 0JAEYKETD 0JAEYKETF 0JAEYKETR 0JAEYKETP 0JAEYKERN 0JAEYKETC 0JAEYKETN 0JAEYKERZ 0JAEYKERQ 0JAEYKERM 0JAEYKERY 0JAEYKET1 0JAEYKETW 0JH6L4M8M 0JH6L4M8Z 0JH6L4M93 0JH6L4M02 0JH6L4M8P 0JH6L4M91 0JH6L4M8C 0JH6L4M81 0JH6L4M8R 0JH6L4M8A 0JH6L4M88 0JH6L4M03 0JH6L4M01 0JH6L4M86 0JH6L4M9F 0JH6L4M04 0JH6L4M89 0JH6L4M9H 0JH6L4M97 0JH6L4M94 0JH6L4M9G 0JH6L4M9K 0J8A18NCP 0JH6L4M96 0JH6L4M9J 0JH6L4M8E 0JH6L4M83 0JH6L4M98 0JH6L4M8D 0JH6L4M9L 0JH6L4M9A 0JH6L4M82 0JH6L4M8F 0JH6L4M9N 0JH6L4M9D 0JH6L4M99 0JH6L4M9M 0JH6L4M9Q 0J8A18NCW 0JH6L4M9C 0JH6L4M9P 0JH6L4N2D 0JH6L4N22 0JH6L4N25 0JH6L4N2E 0HPD2HD46 0JH6L4N23 0HPD2HD47 0JH6L4N2C 0JH6L4N21 0HPD2HD3V 0HPD2HCW0 0JH6L4N29 0JH6L4N1Z 0HPD2HD49 0JH6L4N2A 0JH6L4N27 0JH6L4N1X 0JH6L4N20 0JH6L4N28 0HPD2HD3Z 0HPD2HD3M 0JH6L4N1Y 0HPD2HD40 0HPD2HD44 0HPD2HD3Q 0HPD2HD3N 0HPD2HCV0 0HPD2HCVC 0HPD2HD3T 0HPD2HD41 0HPD2HCV3 0HPD2HCVE 0HPD2HD3P 0HPD2HCV1 0HPD2HCV5 0HPD2HCVG 0HPD2HCVD 0HPD2HCV4 0JH6L4LRF 0J8A18N3X 0J8A18N3E 0JH6L4LRT 0J8A18N3Y 0J8A18N3R 0J8A18N3H 0J8A18N3F 0J8A18N3W 0JH6L4LRU 0JH6L4LT5 0JH6L4LRW 0JH6L4LT7 0JH6L4LT4 0JH6L4LRV 0JH6L4LRY 0JH6L4LTR 0JH6L4LT6 0JH6L4LRX 0JH6L4LTG 0JH6L4LR2 0JH6L4LT8 0JH6L4LTF 0JH6L4LRZ 0JH6L4LTA 0J8A18N3D 0J8A18N3Q 0JH6L4LT1 0JH6L4LTD 0JH6L4LT9 0JH6L4LT0 0JH6L4LT3 0JH6L4LTC 0JH6L4LT2 0JH6L4LTM 0JH6L4LTU 0JH6L4LTE 0JH6L4LTL 0J8A18N1L 0J8A18N1F 0JH6L4LW6 0JH6L4M49 0J8A18N1N 0J8A18N1G 0JH6L4LW4 0J8A18N1M 0J8A18N1Q 0J8A18N22 0J8A18N21 0J8A18N1P 0JH6L4LWA 0J8A18N1H 0JH6L4LWC 0J8A18N1R 0J8A18N1X 0JH6L4LW1 0J8A18N1U 0J8A18N1Z 0JH6L4LVZ 0J8A18N1T 0J8A18N1W 0J8A18N27 0J8A18N1Y 0J8A18N1V 0J8A18N2F 0J8A18N24 0J8A18N20 0J8A18N2E 0J8A18N2H 0J8A18N26 0J8A18N23 0J8A18N2G 0JH6L4LTQ 0JH6L4LU0 0J8A18N25 0J8A18N2J 0JH6L4LTN 0JH6L4LTY 0J8A18N2R 0J66PK328 0J66PK32N 0J66PK32M 0J66PK326 0J66PK32L 0HPD0KMUV 0HPD0KMUJ 0HPD0KMUQ 0HPD0KMUG 0J66PK2V9 0J66PK335 0J66PK2VE 0J66PK334 0J66PK33F 0J66PK333 0HPD0KMUW 0J66PK332 0HPD0KMUL 0HPD0KMUN 0HPD0KMUM 0J66PK33D 0HPD0KMUT 0J66PK33A 0J66PK331 0J66PK339 0J66PK338 0J66PK337 0J66PK32Y 0J66PK32X 0HPD0KMVA 0HPD0KMVC 0HPD0KMV3 0JH6L4KUK 0J8A18M86 0JH6L4KUG 0JH6L4KV0 0JH6L4KV2 0JH6L4KUJ 0JH6L4KUZ 0JH6L4KV7 0J8A18M8C 0JH6L4KUL 0JH6L4KV1 0J8A18M0A 0JH6L4KUT 0J8A18M0C 0JH6L4KUN 0JH6L4KUQ 0J8A18M8D 0JH6L4KUM 0JH6L4KUW 0JH6L4KVJ 0JH6L4KUP 0JH6L4KVD 0JH6L4KV4 0JH6L4KUR 0JH6L4KUX 0JH6L4KV9 0JH6L4KV6 0JH6L4KV3 0JH6L4KV8 0JH6L4KVC 0JH6L4KVP 0JH6L4KVA 0JH6L4KW0 0JH6L4KVR 0JH6L4KVN 0JH6L4KVZ 0JH6L4KW2 0JH6L4KVL 0JH6L4KVQ 0JH6L4KW1 0JH6L4KVF 0JH6L4KUU 0JH6L4KVK 0JH6L4KVE 0JH6L4KVH 0JH6L4KVV 0JH6L4KVM 0J8A18D1T 0HPCNACD0 0J8A18D22 0J8A18D1Q 0J8A18D1U 0J8A18D23 0HPCNACD2 0HPCNACM5 0J8A18D1R 0J8A1… (truncated, 594067 characters total — see the official FDA record for the full value)
Recalling firm:
Abbott Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

Ophthalmic procedure packs may have incomplete seals affecting sterility.

ALL 50 STATES
▸Full report

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

Recall #:
98055
Lot/product code:
UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
Recalling firm:
Alcon Research LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

A certain component of affected devices was not delivered within specification and contained impurities.

ALL 50 STATES
▸Full report

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

Recall #:
98002
Lot/product code:
Model No. M35054; UDI-DI: 04048675228059; Serial No. ASUK-0421,ASUK-0422,ASUK-0423,ASUK-0424,ASUK-0425,ASUK-0426,ASUK-0602,ASUK-0603, ASUK-0705,ASUK-0706,ASUK-0707,ASUK-0708,ASUK-0721,ASUK-0722,ASUK-0723,ASUK-0724, ASUK-0725,ASUK-0726,ASUK-0727,ASUK-0728,ASUK-0729,ASUK-0730,ASUK-0731,ASUK-0732, ASUK-0733,ASUK-0734,ASUK-0735,ASUK-0736,ASUK-0737,ASUK-0738,ASUK-0739,ASUK-0740, ASUK-0749,ASUK-0761,ASUK-0762,ASUK-0763,ASUK-0764,ASUK-0765,ASUK-0766,ASUK-0767, ASUK-0768,ASUK-0769,ASUK-0770,ASUK-0835,ASUK-0836,ASUK-0837,ASUK-0972,ASUK-0973, ASUK-0974,ASUK-0975,ASUK-0993,ASUK-0994,ASUK-0995,ASUK-0996,ASUK-0997,ASUK-0998, ASUK-0999,ASUK-1000,ASUK-1011,ASUK-1015,ASUK-1016,ASUK-1017,ASUK-1018,ASUK-1221, ASUK-1222,ASUK-1232,ASUK-1233,ASUK-1234,ASUK-1235,ASUK-1236,ASUK-1237,ASUK-1239, ASUK-1240,ASUK-1246,ASUK-1306,ASUK-1307,ASUK-1308,ASUK-1309,ASUK-1539,ASUK-1540, ASUK-0428,ASUK-0429,ASUK-0430,ASUK-0431,ASUK-0432,ASUK-0433,ASUK-0434,ASUK-0435, ASUK-0436,ASUK-0437,ASUK-0438,ASUK-0439,ASUK-0440,ASUK-0441,ASUK-0442,ASUK-0443, ASUK-0444,ASUK-0445,ASUK-0446,ASUK-0447,ASUK-0448,ASUK-0449,ASUK-0450,ASUK-0,63, ASUK-0564,ASUK-0565,ASUK-0566,ASUK-0567,ASUK-0568,ASUK-0569,ASUK-0570,ASUK-0571, ASUK-0572,ASUK-0573,ASUK-0574,ASUK-0575,ASUK-0576,ASUK-0577,ASUK-0578,ASUK-0579, ASUK-0580,ASUK-0581,ASUK-0582,ASUK-0583,ASUK-0584,ASUK-0585,ASUK-0601,ASUK-0604, ASUK-0605,ASUK-0606,ASUK-0607,ASUK-0608,ASUK-0609,ASUK-0610,ASUK-0631,ASUK-0632, ASUK-0633,ASUK-0634,ASUK-0635,ASUK-0636,ASUK-0637,ASUK-0638,ASUK-0639,ASUK-0640, ASUK-0641,ASUK-0642,ASUK-0661,ASUK-0662,ASUK-0663,ASUK-0664,ASUK-0667,ASUK-0668, ASUK-0681,ASUK-0682,ASUK-0691,ASUK-0692,ASUK-0693,ASUK-0694,ASUK-0695,ASUK-0696, ASUK-0697,ASUK-0698,ASUK-0699,ASUK-0700,ASUK-0711,ASUK-0712,ASUK-0713,ASUK-0714, ASUK-0715,ASUK-0716,ASUK-0717,ASUK-0718,ASUK-0719,ASUK-0720,ASUK-0741,ASUK-0742, ASUK-0743,ASUK-0744,ASUK-0746,ASUK-0747,ASUK-0748,ASUK-0750,ASUK-0751,ASUK-0752, ASUK-0753,ASUK-0754,ASUK-0755,ASUK-0756,ASUK-0757,ASUK-0758,ASUK-0759,ASUK-0760, ASUK-0778,ASUK-0779,ASUK-0780,ASUK-0781,ASUK-0782,ASUK-0783,ASUK-0784,ASUK-0785, ASUK-0786,ASUK-0787,ASUK-0788,ASUK-0789,ASUK-0790,ASUK-0791,ASUK-0792,ASUK-0793, ASUK-0794,ASUK-0795,ASUK-0796,ASUK-0797,ASUK-0798,ASUK-0799,ASUK-0800,ASUK-0801, ASUK-0802,ASUK-0803,ASUK-0804,ASUK-0805,ASUK-0810,ASUK-0816,ASUK-0817,ASUK-0818, ASUK-0819,,ASUK-0820,ASUK-0821,ASUK-0822,ASUK-0823,ASUK-0824,ASUK-0825,ASUK-0826, ASUK-0827,ASUK-0828,ASUK-0829,ASUK-0830,ASUK-0831,ASUK-0832,ASUK-0833,ASUK-0834, ASUK-0838,ASUK-0839,ASUK-0840,ASUK-0842,ASUK-0843,ASUK-0844,ASUK-0845,ASUK-0846, ASUK-0847,ASUK-0848,ASUK-0849,ASUK-0850,ASUK-0851,ASUK-0852,ASUK-0853,ASUK-0854, ASUK-0855,ASUK-0856,ASUK-0857,ASUK-0858,ASUK-0859,ASUK-0860,ASUK-0871,ASUK-0872, ASUK-0873,ASUK-0874,ASUK-0875,ASUK-0876,ASUK-0877,ASUK-0878,ASUK-0879,ASUK-0880, ASUK-0891,ASUK-0892,ASUK-0893,ASUK-0894,ASUK-0916,ASUK-0917,ASUK-0918,ASUK-0919, ASUK-0920,ASUK-0921,ASUK-0922,ASUK-0923,ASUK-0924,ASUK-0925,ASUK-0930,ASUK-0931, ASUK-0964,ASUK-0965,ASUK-0971,ASUK-0976,ASUK-0977,ASUK-0978,ASUK-0979,ASUK-0980, ASUK-0981,ASUK-0982,ASUK-0983,ASUK-0984,ASUK-0985,ASUK-0986,ASUK-0987,ASUK-0988, ASUK-0989,ASUK-0990,ASUK-0991,ASUK-0992,ASUK-1001,ASUK-1002,ASUK-1003,ASUK-1005, ASUK-1006,ASUK-1007,ASUK-1008,ASUK-1009,ASUK-1010,ASUK-1012,ASUK-1014,ASUK-1019, ASUK-1020,ASUK-1061,ASUK-1062,ASUK-1063,ASUK-1064,ASUK-1065,ASUK-1066,ASUK-1070, ASUK-1071,ASUK-1073,ASUK-1074,ASUK-1075,ASUK-1076,ASUK-1077,ASUK-1078,ASUK-1079, ASUK-1080,ASUK-1081,ASUK-1082,ASUK-1084,ASUK-1085,ASUK-1086,ASUK-1087,ASUK-1088, ASUK-1089,ASUK-1090,ASUK-1091,ASUK-1092,ASUK-1093,ASUK-1094,ASUK-1095,ASUK-1096, ASUK-1097,ASUK-1098,ASUK-1099,ASUK-1100,ASUK-1121,ASUK-1122,ASUK-1123,ASUK-1124, ASUK-1125,ASUK-1126,ASUK-1127,ASUK-1128,ASUK-1129,ASUK-1130,ASUK-1230,ASUK-1231, ASUK-1241,ASUK-1242,ASUK-1243,ASUK-1244,ASUK-1245,ASUK-1247,ASUK-1261,ASUK-1262, ASUK-1263,ASUK-1264,ASUK-1265,ASUK-1266,ASUK-1267,ASUK-1268,ASUK-1269,ASUK-1270, ASUK-1271,ASUK-1272,ASUK-1273,ASUK-1274,ASUK-1275,ASUK-1276,ASUK-1277,ASUK-1278, ASUK-1279,ASUK-1280,ASUK-1288,ASUK-1289,ASUK-1291,ASUK-1292,ASUK-1293,ASUK-1294, ASUK-1295,ASUK-1296,ASUK-1297,ASUK-1298,ASUK-1299,ASUK-1300,ASUK-1301,ASUK-1302, ASUK-1305,ASUK-1311,ASUK-1312,ASUK-1313,ASUK-1314,ASUK-1315,ASUK-1352,ASUK-1353, ASUK-1357,ASUK-1358,ASUK-1360,ASUK-1463,ASUK-1464,ASUK-1465,ASUK-1466,ASUK-1492, ASUK-1493,ASUK-1496,ASUK-1497,ASUK-1498,ASUK-1499,ASUK-1500,ASUK-1532.
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Removal of affected lot of screws due to labeling error.

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

Recall #:
98051
Lot/product code:
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

A certain component of affected devices was not delivered within specification and contained impurities.

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

Recall #:
98002
Lot/product code:
Model No. M36500; UDI-DI: 04048675301363; Serial No. ASUK-1181,ASUK-1186,ASUK-1187,ASUK-1196,ASUK-1197,ASUK-1198,ASUK-1199,ASUK-1200, ASUK-1201,ASUK-1202,ASUK-1203,ASUK-1204,ASUK-1205,ASUK-1206,ASUK-1207,ASUK-1208, ASUK-1209,ASUK-1210,ASUK-1211,ASUK-1212,ASUK-1213,ASUK-1214,ASUK-1215,ASUK-1216, ASUK-1217,ASUK-1218,ASUK-1219,ASUK-1220,ASUK-1590,ASUK-1591,ASUK-1592,ASUK-1611, ASUK-1613,ASUK-1616,ASUK-1617,ASUK-1618,ASUK-1619, ASUK-0241,ASUK-0242,ASUK-0243,ASUK-0244,ASUK-0245,ASUK-0246,ASUK-0247,ASUK-0248, ASUK-0249,ASUK-0250,ASUK-0451,ASUK-0452,ASUK-0453,ASUK-0454,ASUK-0455,ASUK-0456, ASUK-0457,ASUK-0458,ASUK-0459,ASUK-0460,ASUK-0461,ASUK-0462,ASUK-0463,ASUK-0464, ASUK-0465,ASUK-0466,ASUK-0467,ASUK-0468,ASUK-0469,ASUK-0470,ASUK-0471,ASUK-0472, ASUK-0473,ASUK-0474,ASUK-0475,ASUK-0476,ASUK-0477,ASUK-0478,ASUK-0479,ASUK-0480, ASUK-0481,ASUK-0482,ASUK-0483,ASUK-0484,ASUK-0486,ASUK-0487,ASUK-0488,ASUK-0489, ASUK-0490,ASUK-0491,ASUK-0492,ASUK-0493,ASUK-0494,ASUK-0495,ASUK-0496,ASUK-0497, ASUK-0498,ASUK-0499,ASUK-0500,ASUK-0501,ASUK-0502,ASUK-0503,ASUK-0504,ASUK-0505, ASUK-0506,ASUK-0507,ASUK-0508,ASUK-0509,ASUK-0510,ASUK-0511,ASUK-0512,ASUK-0513, ASUK-0514,ASUK-0515,ASUK-0516,ASUK-0517,ASUK-0518,ASUK-0519,ASUK-0520,ASUK-0521, ASUK-0522,ASUK-0523,ASUK-0524,ASUK-0525,ASUK-0526,ASUK-0527,ASUK-0528,ASUK-0529, ASUK-0530,ASUK-0531,ASUK-0532,ASUK-0533,ASUK-0534,ASUK-0535,ASUK-0536,ASUK-0537, ASUK-0538,ASUK-0539,ASUK-0540,ASUK-0541,ASUK-0542,ASUK-0543,ASUK-0544,ASUK-0545, ASUK-0546,ASUK-0547,ASUK-0548,ASUK-0549,ASUK-0550,ASUK-0551,ASUK-0552,ASUK-0553, ASUK-0554,ASUK-0555,ASUK-0556,ASUK-0557,ASUK-0558,ASUK-0559,ASUK-0560,ASUK-1181, ASUK-1182,ASUK-1183,ASUK-1184,ASUK-1185,ASUK-1191,ASUK-1192,ASUK-1193,ASUK-1194, ASUK-1195,ASUK-1581,ASUK-1582,ASUK-1583,ASUK-1584,ASUK-1585,ASUK-1586,ASUK-1587, ASUK-1588,ASUK-1589,ASUK-1593,ASUK-1594,ASUK-1595,ASUK-1596,ASUK-1597,ASUK-1598, ASUK-1599,ASUK-1600,ASUK-1602,ASUK-1612,ASUK-1614,,ASUK-1615,ASUK-1620.
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

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

Recall #:
98022
Lot/product code:
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

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

Recall #:
98000
Lot/product code:
version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)