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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.

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: 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.

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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) 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
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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

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.

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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: 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
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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

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
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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

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
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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)
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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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)
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
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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, 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

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

Recall #:
D-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)
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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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)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 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: 72080-01 UDI-DI Code: 00357599819002 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

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.

ALL 50 STATES
▸Full report

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)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 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: 78768-01 UDI-DI Code:00357599844011 Product Expiry Date: 12/31/2025 Kit Pack Lot Number: T60003138 Pack Serial Numbers: 0HWDCHEU5 0HWD9FV3H 0HWD9FV36 0HWDCHEUG 0HWD9FV3J 0HWD9FV34 0HWD9FV37 0HWD9FV3G 0HWD9FUVX 0HWD9FV40 0HWD9FV35 0HWD9FV3K 0HWD9FUVZ 0HWD9FV3Y 0HWD9FV38 0HWD9FUVY 0HWD9FV3W 0HWD9FV32 0HWD9FV3Z 0HWD9FUW0 0HWD9FV2Q 0HWD9FV30 0HWD9FUW1 0HWD9FV2R 0HWD9FUW2 0HWD9FV3V 0HWD9FV31 0HWD9FV3E 0HWD9FV43 0HWD9FV33 0HWD9FUW3 0HWDCHEAD 0HWDCHEAQ 0HWDCHEAE 0HWD9FULN 0HWD9FULP 0HWD9FULM 0HWD9FULC 0HWD9FULL 0HWD9FULA 0HWDCHEAR 0HWD9FULK 0HWDCHEAT 0HWDCHEAG 0HWDCHEAU 0HWDCHEAH 0HWDCHEAV 0HWDCHEAJ 0HWDCHEAW 0HWDCHEAK 0HWD9FULH 0HWD9FULJ 0HWD9FULG 0HWD9FULD 0HWD9FULF 0HWD9FUL5 0HWD9FUL8 0HWD9FULE 0HWD9FUKR 0HWD9FUL2 0HWD9FUKQ 0HWD9FUL1 0HWD9FUKP 0HWD9FUL0 0HWD9FUKN 0HWD9FUKZ 0HWD9FUKM 0HWD9FUKY 0HWDCHEC9 0HWDCHEAX 0HWDCHECA 0HWDCHEAY 0HWD9FUL3 0HWDCHEAZ 0HWD9FUKL 0HWD9FUKX 0HWD9FUKK 0HWD9FUKW 0HWD9FUKV 0HKCMAM2P 0HKCMAM2E 0HKCMAM2N 0HKCMAM2D 0HKCMAM2M 0HKCMAM2C 0HPCNHMJT 0HKCMAM2A 0HPCNHMJX 0HPCNHMJG 0HPCNHMJW 0HPCNHN24 0HPCNHN1T 0HPCNHN23 0HPCNHN1R 0HPCNHN22 0HPCNHN1Q 0HPCNHN21 0HKCMAMK8 0HKCMAMKK 0HKCMAMK7 0HKCMAMKJ 0HKCMAMK6 0HKCMAMKH 0HKCMAM02 0HKCMAMKG 0HKCMAM01 0HKCMAM81 0HKCMAM0A 0HKCMAM82 0HKCMAM09 0HKCMAM8K 0HKCMAM88 0HKCMAM8L 0HKCMAM8M 0HKCMAM8A 0HKCMAM8N 0HKCMAM8C 0HKCMAM84 0HKCMAM8D 0HKCMAM85 0HKCMAM06 0HKCMAM86 0HKCMAM05 0HKCMAM87 0HKCMAM04 0HKCMAM8Q 0HKCMAM8E 0HKCMAM8R 0HKCMAM8T 0HKCMAM8G 0HKCMAM8U 0HKCMAM8H 0HKCMAM8P 0HKCMAM8J 0HPCNHMU7 0HPCNHMTX 0HPCNHMU8 0HPCNHMTY 0HPCNHMTZ 0HPCNHMUA 0HPCNHMU0 0HPCNHMUD 0HPCNHMU1 0HPCNHMRD 0HPCNHMT9 0HPCNHMTT 0HKCMAN0Z 0HKCMAN18 0HPCNHNR4 0HPCNHNRA 0HKCMAN0X 0HKCMAN16 0HKCMAN19 0HKCMAN0V 0HKCMAN0N 0HKCMAN17 0HKCMAN0W 0HKCMAN0A 0HWD9FW2Z 0HWD9FW2N 0HWD9FW30 0HWD9FW31 0J8A18P31 0HWD9FW32 0J8A18P32 0J8A18P3C 0J8A18P33 0J8A18P3D 0HWD9FW2R 0J8A18P3E 0HWD9FW2T 0HWD9FW33 0HWD9FW2U 0HWD9FW34 0HWD9FW2V 0HWD9FW2W 0HWD9FW36 0J8A18P3F 0HWD9FW37 0J8A18P3G 0HWD9FW3V 0HWD9FW3X 0HU6HAW21 0HU6HAW1N 0HU6HAW20 0HU6HAW1M 0HU6HAW1Z 0HU6HAW1Y 0HU6HAW1K 0HU6HAW1X 0HWD9FW3D 0HWD9FW3Q 0HWD9FW3U 0HWD9FW3N 0HWD9FW3T 0HWD9FW3F 0J8A18P43 0J8A18P3R 0J8A18P3H 0J8A18P3T 0J8A18P3U 0J8A18P3K 0J8A18P3V 0HWD9FW38 0J8A18P3W 0HWD9FW39 0HWD9FW3A 0HWD9FW3L 0J8A18P3L 0HWD9FW3M 0J8A18P3M 0J8A18P3X 0J8A18P3N 0J8A18P3Y 0J8A18P3P 0J8A18P3Q 0J8A18P42 0HWD9FW3E 0HWD9FWJY 0HWD9FWJZ 0HWD9FWK8 0HWD9FWKA 0HWD9FWLG 0HWD9FWL5 0HWD9FWLH 0HWD9FWL6 0HWD9FWLJ 0HWD9FWKC 0HWD9FWK3 0HWD9FWKE 0HWD9FWKG 0HWD9FWLM 0HWD9FWLA 0HWD9FWLN 0HWD9FWLC 0HWD9FWLP 0HWD9FWLD 0HKCN6KMA 0HKCN6KLZ 0HKCN6KM9 0HPCNHRTG 0HPCNHRTU 0HPCNHRTH 0HPCNHRTV 0HPCNHRTJ 0HPCNHRTW 0HPCNHRTK 0HKCN6KLX 0HPCNHRTL 0HKCN6KLW 0HKCN6KM6 0HKCN6KM5 0HKCN6KM4 0HPCNHRTN 0HPCNHRU0 0HPCNHRTP 0HPCNHRU1 0HPCNHRTQ 0HPCNHRTX 0HPCNHRTR 0HPCNHRUE 0HPCNHRU3 0HPCNHRUF 0HPCNHRU4 0HPCNHRUG 0HPCNHRU5 0HPCNHRUH 0HPCNHRU6 0HPCNHRUJ 0HPCNHRU7 0HPCNHRV1 0HPCNHRV2 0HPCNHRUR 0HPCNHRU2 0HPCNHRUK 0HPCNHRU8 0HPCNHRUL 0HPCNHRU9 0HPCNHRUM 0HPCNHRUA 0HPCNHRUN 0HPCNHRUC 0HPCNHRUP 0HPCNHRUD 0HPCNHRV6 0HPCNHRUW 0HPCNHRV7 0HPCNHRW5 0HPCNHT3Y 0HPCNHRW7 0HPCNHT42 0HPCNHT47 0HPCNHT41 0HPCNHRW4 0HPCNHRVN 0HPCNHRVC 0HPCNHRVP 0HPCNHRVD 0HPCNHRVF 0HPCNHRVE 0HPCNHRVG 0HPCNHRVR 0HKCN6KKH 0HPCNHRVT 0HKCN6KKG 0HKCN6KK6 0HPCNHT3X 0HKCN6KK5 0HPCNHT3W 0HPCNHT46 0HPCNHRVV 0HPCNHRVH 0HPCNHRVW 0HPCNHRVJ 0HPCNHRVK 0HPCNHRVM 0HWD9FUKH 0HWD9FUKU 0HWD9FUKT 0HWDCHECF 0HWDCHEC2 0HWDCHECG 0HWDCHECC 0HWDCHEC4 0HWD9FUL9 0HWDCHEC0 0HWDCHEC1 0HWDCHECX 0HWDCHECY 0HWDCHECM 0HWDCHECZ 0HWDCHECN 0HWDCHECQ 0HWDCHECP 0HWD9FUKF 0HWDCHED1 0HWDCHECJ 0HWDCHECH 0HWDCHECV 0HWDCHEC6 0HWDCHECK 0HWDCHEC7 0HWDCHED2 0HWDCHECR 0HWDCHED3 0HWDCHECT 0HWDCHED4 0HWDCHECU 0HWDCHECW 0HWD9FUK8 0HWDCHED6 0HWD9FUKE 0HWD9FUJY 0HWD9FUKD 0HWD9FUK1 0HWD9FUK9 0HWD9FUK2 0HWD9FUJZ 0HWDCHED9 0HWD9FUKA 0HWDCHED8 0HWDCHEM5 0HWD9FUK0 0HWDCHED7 0HWDCHEDA 0HWDCHEM3 0HWDCHEM6 0HWD9FUK6 0HWDCHEM4 0HWD9FUJW 0HWD9FUK7 0HWDCHE1V 0HWDCHEHK 0HWDCHEJ0 0HWDCHEJC 0HWDCHEHZ 0HWDCHEJA 0HWD9FUU8 0HWDCHEJ9 0HWDCHEHJ 0HWD9FUUL 0HWDCHEH6 0HWDCHEHH 0HWDCHEH5 0HWDCHEHG 0HWDCHEH4 0HWDCHEHF 0HWDCHEH3 0HWDCHEHE 0HWDCHEHV 0HWDCHEJ6 0HWDCHEHU 0HWDCHEJ5 0HWD9FUAT 0HWDCHEJ4 0HWDCHF3Q 0HWD9FVA5 0HWD9FVAC 0HWDCHF0G 0HWD9FVA4 0HWD9FVA2 0HWD9FVAE 0HWD9FVAA 0HWD9FVA1 0HKCMAN0L 0HKCMAN15 0HKCMAN0C 0HKCMAN0U 0HKCMAN13 0HKCMAN0M 0HKCMAN11 0HKCMAN14 0HKCMAN0P 0HKCMAN0H 0HKCMAN12 0HKCMAN0Q 0HKCMAN05 0HKCMAN0F 0HKCMAN10 0HKCMAN06 0HKCMAN0J 0HKCMAN0G 0HPCNHNTK 0HPCNHNT9 0HKCMAN0K 0HPCNHNTM 0HPCNHNTC 0HPCNHNTL 0HPCNHNRM 0HPCNHNTA 0HPCNHNTN 0HKCMAN03 0HKCMAN04 0HPCNHNTQ 0HPCNHNTF 0HKCMAN02 0HPCNHNTH 0HPCNHNTE 0HPCNHNTR 0HKCMAN1W 0HKCMAN1K 0HPCNHNHX 0HKCMAN1X 0HKCMAN1U 0HKCMAN1H 0HKCMAN1L 0HPCNHNHP 0HPCNHNHN 0HKCMAN1J 0HKCMAN1T 0HPCNHNJ1 0HPCNHNHQ 0HKCMAN1G 0HPCNHNJ2 0HKCMAN1Q 0HPCNHNHR 0HKCMAN1R 0HKCMAN1N 0HKCMAN1C 0HKCMAN1F 0HKCMAN1P 0HPCNHNHH 0HPCNHNHG 0HKCMAN1D 0HKCMAN1M 0HPCNHNH5 0HPCNHNHL 0HKCMAN1A 0HPCNHNH6 0HPCNHNH3 0HPCNHNRH 0HPCNHNHM 0HPCNHNH4 0HPCNHNR7 0HPCNHNHJ 0HPCNHNR6 0HPCNHNR9 0HPCNHNHC 0HPCNHNRJ 0HPCNHNR8 0HPCNHNHE 0HPCNHNRL 0HPCNHNHA 0HWD9FWLK 0HWD9FWLE 0HWD9FWLL 0HWD9F… (truncated, 1333431 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

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

The devices may have a misaligned thickness control bar.

ALL 50 STATES
▸Full report

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

Recall #:
98024
Lot/product code:
Lot Code: Model No 00880100100, UDI (01)00889024375901(21)115821, Lot Number 65944745, Serial Number 115821; Model No 00880100100, UDI (01)00889024375901(21)115824, Lot Number 65944745, Serial Number 115824; Model No 00880100100, UDI (01)00889024375901(21)115826, Lot Number 65944745, Serial Number 115826; Model No 00880100100, UDI (01)00889024375901(21)115827, Lot Number 65944745, Serial Number 115827; Model No 00880100100, UDI (01)00889024375901(21)115829, Lot Number 65944745, Serial Number 115829; Model No 00880100100, UDI (01)00889024375901(21)115831, Lot Number 65944745, Serial Number 115831; Model No 00880100100, UDI (01)00889024375901(21)115832, Lot Number 65944745, Serial Number 115832; Model No 00880100100, UDI (01)00889024375901(21)115834, Lot Number 65944745, Serial Number 115834; Model No 00880100100, UDI (01)00889024375901(21)115835, Lot Number 65944745, Serial Number 115835; Model No 00880100100, UDI (01)00889024375901(21)115836, Lot Number 65944745, Serial Number 115836; Model No 00880100100, UDI (01)00889024375901(21)115838, Lot Number 65944745, Serial Number 115838; Model No 00880100100, UDI (01)00889024375901(21)115839, Lot Number 65944748, Serial Number 115839; Model No 00880100100, UDI (01)00889024375901(21)115841, Lot Number 65944748, Serial Number 115841; Model No 00880100100, UDI (01)00889024375901(21)115842, Lot Number 65944748, Serial Number 115842; Model No 00880100100, UDI (01)00889024375901(21)115843, Lot Number 65944748, Serial Number 115843; Model No 00880100100, UDI (01)00889024375901(21)115845, Lot Number 65944748, Serial Number 115845; Model No 00880100100, UDI (01)00889024375901(21)115846, Lot Number 65944748, Serial Number 115846; Model No 00880100100, UDI (01)00889024375901(21)115847, Lot Number 65944748, Serial Number 115847; Model No 00880100100, UDI (01)00889024375901(21)115848, Lot Number 65944748, Serial Number 115848; Model No 00880100100, UDI (01)00889024375901(21)115850, Lot Number 65944748, Serial Number 115850; Model No 00880100100, UDI (01)00889024375901(21)115853, Lot Number 65944748, Serial Number 115853; Model No 00880100100, UDI (01)00889024375901(21)115854, Lot Number 65944748, Serial Number 115854; Model No 00880100100, UDI (01)00889024375901(21)115855, Lot Number 65944748, Serial Number 115855; Model No 00880100100, UDI (01)00889024375901(21)115856, Lot Number 65944748, Serial Number 115856; Model No 00880100100, UDI (01)00889024375901(21)115857, Lot Number 65944748, Serial Number 115857; Model No 00880100100, UDI (01)00889024375901(21)115858, Lot Number 65944748, Serial Number 115858; Model No 00880100100, UDI (01)00889024375901(21)115859, Lot Number 65944750, Serial Number 115859; Model No 00880100100, UDI (01)00889024375901(21)115860, Lot Number 65944750, Serial Number 115860; Model No 00880100100, UDI (01)00889024375901(21)115861, Lot Number 65944750, Serial Number 115861; Model No 00880100100, UDI (01)00889024375901(21)115864, Lot Number 65944750, Serial Number 115864; Model No 00880100100, UDI (01)00889024375901(21)115865, Lot Number 65944750, Serial Number 115865; Model No 00880100100, UDI (01)00889024375901(21)115866, Lot Number 65944750, Serial Number 115866; Model No 00880100100, UDI (01)00889024375901(21)115868, Lot Number 65944750, Serial Number 115868; Model No 00880100100, UDI (01)00889024375901(21)115869, Lot Number 65944750, Serial Number 115869; Model No 00880100100, UDI (01)00889024375901(21)115872, Lot Number 65944750, Serial Number 115872; Model No 00880100100, UDI (01)00889024375901(21)115873, Lot Number 65944750, Serial Number 115873; Model No 00880100100, UDI (01)00889024375901(21)115874, Lot Number 65944750, Serial Number 115874; Model No 00880100100, UDI (01)00889024375901(21)115875, Lot Number 65944750, Serial Number 115875; Model No 00880100100, UDI (01)00889024375901(21)115877, Lot Number 65944750, Serial Number 115877; Model No 00880100100, UDI (01)00889024375901(21)115879, Lot Number 65944752, Serial Number 115879; Model No 00880100100, UDI (01)00889024375901(21)115882, Lot Number 65944752, Serial Number 115882; Model No 00880100100, UDI (01)00889024375901(21)115883, Lot Number 65944752, Serial Number 115883; Model No 00880100100, UDI (01)00889024375901(21)115884, Lot Number 65944752, Serial Number 115884; Model No 00880100100, UDI (01)00889024375901(21)115885, Lot Number 65944752, Serial Number 115885; Model No 00880100100, UDI (01)00889024375901(21)115886, Lot Number 65944752, Serial Number 115886; Model No 00880100100, UDI (01)00889024375901(21)115887, Lot Number 65944752, Serial Number 115887; Model No 00880100100, UDI (01)00889024375901(21)115889, Lot Number 65944752, Serial Number 115889; Model No 00880100100, UDI (01)00889024375901(21)115890, Lot Number 65944752, Serial Number 115890; Model No 00880100100, UDI (01)00889024375901(21)115891, Lot Number 65944752, Serial Number 115891; Model No 00880100100, UDI (01)00889024375901(21)115892, Lot Number 65944752, Serial Number 115892; Model No 00880100100, UDI (01)0088902437… (truncated, 84654 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical 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.

ALL 50 STATES
▸Full report

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

Zimmer Dermatome AN, Model/Catalog Number: 88710100

The devices may have a misaligned thickness control bar.

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

Recall #:
98024
Lot/product code:
Lot Code: Model No 88710100, UDI 00889024464834701341, Lot Number 65900465, Serial Number 701341; Model No 88710100, UDI 00889024464834701343, Lot Number 65900465, Serial Number 701343; Model No 88710100, UDI 00889024464834701344, Lot Number 65900465, Serial Number 701344; Model No 88710100, UDI 00889024464834701345, Lot Number 65900465, Serial Number 701345; Model No 88710100, UDI 00889024464834701346, Lot Number 65900465, Serial Number 701346; Model No 88710100, UDI 00889024464834701350, Lot Number 65900465, Serial Number 701350; Model No 88710100, UDI 00889024464834701351, Lot Number 65900465, Serial Number 701351; Model No 88710100, UDI 00889024464834701352, Lot Number 65900465, Serial Number 701352; Model No 88710100, UDI 00889024464834701353, Lot Number 65900465, Serial Number 701353; Model No 88710100, UDI 00889024464834701354, Lot Number 65900465, Serial Number 701354; Model No 88710100, UDI 00889024464834701355, Lot Number 65900465, Serial Number 701355; Model No 88710100, UDI 00889024464834701356, Lot Number 65900465, Serial Number 701356; Model No 88710100, UDI 00889024464834701357, Lot Number 65900465, Serial Number 701357; Model No 88710100, UDI 00889024464834701359, Lot Number 65900465, Serial Number 701359; Model No 88710100, UDI 00889024464834701361, Lot Number 65944825, Serial Number 701361; Model No 88710100, UDI 00889024464834701362, Lot Number 65944825, Serial Number 701362; Model No 88710100, UDI 00889024464834701363, Lot Number 65944825, Serial Number 701363; Model No 88710100, UDI 00889024464834701364, Lot Number 65944825, Serial Number 701364; Model No 88710100, UDI 00889024464834701365, Lot Number 65944825, Serial Number 701365; Model No 88710100, UDI 00889024464834701366, Lot Number 65944825, Serial Number 701366; Model No 88710100, UDI 00889024464834701367, Lot Number 65944825, Serial Number 701367; Model No 88710100, UDI 00889024464834701368, Lot Number 65944825, Serial Number 701368; Model No 88710100, UDI 00889024464834701369, Lot Number 65944825, Serial Number 701369; Model No 88710100, UDI 00889024464834701370, Lot Number 65944825, Serial Number 701370; Model No 88710100, UDI 00889024464834701371, Lot Number 65944825, Serial Number 701371; Model No 88710100, UDI 00889024464834701372, Lot Number 65944825, Serial Number 701372; Model No 88710100, UDI 00889024464834701374, Lot Number 65944825, Serial Number 701374; Model No 88710100, UDI 00889024464834701375, Lot Number 65944825, Serial Number 701375; Model No 88710100, UDI 00889024464834701376, Lot Number 65944825, Serial Number 701376; Model No 88710100, UDI 00889024464834701377, Lot Number 65944825, Serial Number 701377; Model No 88710100, UDI 00889024464834701378, Lot Number 65944825, Serial Number 701378; Model No 88710100, UDI 00889024464834701379, Lot Number 65944825, Serial Number 701379; Model No 88710100, UDI 00889024464834701380, Lot Number 65944825, Serial Number 701380; Model No 88710100, UDI 00889024464834701381, Lot Number 66016265, Serial Number 701381; Model No 88710100, UDI 00889024464834701386, Lot Number 66016265, Serial Number 701386; Model No 88710100, UDI 00889024464834701387, Lot Number 66016265, Serial Number 701387; Model No 88710100, UDI 00889024464834701388, Lot Number 66016265, Serial Number 701388; Model No 88710100, UDI 00889024464834701390, Lot Number 66016265, Serial Number 701390; Model No 88710100, UDI 00889024464834701391, Lot Number 66016265, Serial Number 701391; Model No 88710100, UDI 00889024464834701393, Lot Number 66016265, Serial Number 701393; Model No 88710100, UDI 00889024464834701395, Lot Number 66016265, Serial Number 701395; Model No 88710100, UDI 00889024464834701396, Lot Number 66016265, Serial Number 701396; Model No 88710100, UDI 00889024464834701397, Lot Number 66016265, Serial Number 701397; Model No 88710100, UDI 00889024464834701398, Lot Number 66016265, Serial Number 701398; Model No 88710100, UDI 00889024464834701399, Lot Number 66016265, Serial Number 701399; Model No 88710100, UDI 00889024464834701400, Lot Number 66016265, Serial Number 701400; Model No 88710100, UDI 00889024464834701402, Lot Number 66121190, Serial Number 701402; Model No 88710100, UDI 00889024464834701403, Lot Number 66121190, Serial Number 701403; Model No 88710100, UDI 00889024464834701404, Lot Number 66121190, Serial Number 701404; Model No 88710100, UDI 00889024464834701405, Lot Number 66121190, Serial Number 701405; Model No 88710100, UDI 00889024464834701406, Lot Number 66121190, Serial Number 701406; Model No 88710100, UDI 00889024464834701410, Lot Number 66121190, Serial Number 701410; Model No 88710100, UDI 00889024464834701411, Lot Number 66121190, Serial Number 701411; Model No 88710100, UDI 00889024464834701413, Lot Number 66121190, Serial Number 701413; Model No 88710100, UDI 00889024464834701415, Lot Number 66121190, Serial Number 701415; Model No 88710100, UDI 00889024464834701416, Lot Number 66121190, Serial Number 701416; Model No 88710100, UDI 00889024464834701417, Lot Number 661211… (truncated, 44185 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical 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
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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.

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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 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

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 2000. 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. 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

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 22, 2025

The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein/2025043007(04/29/2027); Vivoo Ketone Test/2024013122(01/30/2026)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

Male Fertility Sperm Test for Home Use (Cassette)

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2025

LH One Step Ovulation Test Device (Urine)

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

ALL 50 STATES
▸Full report

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

Recall #:
97801
Lot/product code:
Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)
Recalling firm:
Changchun Wancheng Bio-Electron Co., Ltd.
View official FDA record (opens in a new tab)