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Recalls affecting Alabama

Data last updated: September 10, 2026 at 1:16 PM UTC

16,873 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled February 17, 2026

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

Defective container; inadequately sealed blister packaging.

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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-0383-2026
Lot/product code:
Lot # N02640, Exp Date: 08/2027
Recalling firm:
The Harvard Drug Group LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 17, 2026

See Luer Cap Set, MPC-130, set, administration, intravascular

Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.

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

Recall #:
98469
Lot/product code:
UDI +B144MPC1300/$$529105203895, Lot Number 20389
Recalling firm:
Molded Products Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

THORACIC ROBOTS, DYNJ908777B

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

ALL 50 STATES
▸Full report

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

Recall #:
98530
Lot/product code:
UDI-DI 10198459269196 (EA) 40198459269197 (CS) LOTS 25EBD732 25GBG733 25IBQ613 25JBD457 25KBT352 26ABA235 26ABP735
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

ALL 50 STATES
▸Full report

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

Recall #:
98530
Lot/product code:
1. UDI-DI 10195327501259 (EA) 40195327501250 (CS) LOTS 24DBW065 24EBV301 24HBB492 24JBW143 25ABG413 25CBH359 25DBD213 25GBP569 25HBQ088 25KBF725 26ABE643 2. UDI-DI 10195327371029 (EA) 40195327371020 (CS) LOTS 24FBM018 24GBL319
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

ALL 50 STATES
▸Full report

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

Recall #:
98530
Lot/product code:
1. DYNJ900898I UDI-DI 10198459273513 (EA) 40198459273514 (CS) LOTS 25DME064 25HMD841 25JMD489 25KME329 25KMH848 25LMC029 25LMH235 25LMK305 DYNJ901922G UDI-DI 10195327640422 (EA) 40195327640423 (CS) LOTS 24KBP812 2. DYKM1417I UDI-DI 10195327456757 (EA) 40195327456758 (CS) LOTS 24DLA405 24ELA912 24GLA871 24ILA151 24JLA326 DYKM1417J UDI-DI 10198459191640 (EA) 40198459191641 (CS) LOTS 25BLA761 25BLA886 25DLA353 25ELA056 25FLA429 25HLA196 25HLA242 25KLA388 25KLA610 3. DYNJ58146A UDI-DI 10193489611977 (EA) 40193489611978 (CS) LOTS 23KDA851 24ADC096 24CDB107 24DDB887 24IDA855 24JDB494 24LDA691 25BMF825 25DMD969 25FMC760 25GMD422 4. DYNDA2138A UDI-DI 10193489874594 (EA) 40193489874595 (CS) 24DBM325 24DBM383 25DBK159
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O 13. XPS, DYNJ907605

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

ALL 50 STATES
▸Full report

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

Recall #:
98530
Lot/product code:
1. DYKE2091 UDI-DI 10198459606397 (EA) 40198459606398 (CS) LOT 25LBR616 2. DYNJ900898G UDI-DI 10195327479473 (EA) 40195327479474 (CS) LOTS 23JBI824 23KBJ535 24ABR789 24ABV917 24BBU610 24DMK530 24FMF039 24GME122 24JMB670 24KMH657 25AMA403 25BME938 DYNJ901922I UDI-DI 10198459237270 (EA) 40198459237271 (CS) LOTS 25BBL628 25FBM655 25HBW072 25KBO230 3. DYNJ38313B UDI-DI 10884389857700 (EA) 40884389857701 (CS) LOTS 24BBR676 24CBF032 24FBD924 24JBE567 25EBA277 25FBO580 25IBI418 4. DYNJ32750G UDI-DI 10889942212491 (EA) 40889942212492 (CS) LOTS 23KME954 23LMD492 24BMF722 24FMH267 24HMC509 DYNJ32750I UDI-DI 10198459245695 (EA) 40198459245696 (CS) LOTS 25BMA765 25DMC474 25EMI991 25IME718 26AMJ190 5. DYNJ911252 UDI-DI 10198459305030 (EA) 40198459305031 (CS) LOTS 25EBU007 25LBC286 25LBI365 26ABC803 26ABU372 6. DYNJ58146B UDI-DI 10198459478253 (EA) 40198459478254 (CS) LOTS 25HMG837 25JMJ636 26AMJ160 7. DYNJ902016K UDI-DI 10195327391706 (EA) 40195327391707 (CS) LOTS 23JBL313 23KBX206 24ABG361 24ABS317 24CBU624 24DBT777 24EBP517 24IBB815 24LBH029 24LBK316 25BBD830 25BBK993 25DBQ241 25DBR926 DYNJ902016L UDI-DI 10198459452703 (EA) 40198459452704 (CS) LOTS 25HBV912 25IBT298 25KBT137 8. DYNJ908686 UDI-DI 10195327145330 (EA) 40195327145331 (CS) LOT 23LBG479 9. DYKE1859 UDI-DI 10195327171469 (EA) 40195327171460 (CS) LOTS 23LBU165 24ABT730 24CBL345 24FBK106 24HBJ512 25DBS024 25EBL346 10. DYNJ901666L UDI-DI 10193489986815 (EA) 40193489986816 (CS) LOTS 24DDC241 24EDB399 11. DYNJ908777A UDI-DI 10195327415174 (EA) 40195327415175 (CS) LOTS 23JBV709 23KBC057 23LBP026 23LBP071 23LBP286 24BBH036 24DBD851 24FBC615 24GBH920 24HBS270 24KBL822 25ABE547 25BBP040 25BBR359 25CBA577 12. DYNJ900482N UDI-DI 10195327509941 (EA) 40195327509942 (CS) LOTS 23KDB600 24ADA178 DYNJ900482O UDI-DI 10195327596569 (EA) 40195327596560 (CS) LOTS 24CDA456 24EDC051 24GDB830 24IDB049 24JDB140 24KDA731 25ADB869 25BDA267 25CMD906 13. DYNJ907605 UDI-DI 10193489468052 (EA) 40193489468053 (CS) LOTS 23JBA743 23JBI519 23LBQ647 24ABX014 24BBQ594
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm

Drainable large pouch may leak due to manufacturing issue.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
98455
Lot/product code:
UDI: 00768455221400/ Lot: 5J03908
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

Drainable large pouch may leak due to manufacturing issue.

ALL 50 STATES
▸Full report

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

Recall #:
98455
Lot/product code:
UDI: 00768455221264 Lot: 5K00011,5K00714
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

ALL 50 STATES
▸Full report

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

Recall #:
98530
Lot/product code:
1. UDI-DI 10198459629334 (EA) 40198459629335 (CS) LOTS 26AMG895 2. UDI-DI 10198459545283 (EA) 40198459545284 (CS) LOTS 25LBJ366 26ABR365 3. UDI-DI 10195327471859 (EA) 40195327471850 (CS) LOTS 24EBA317 24EBV431 24IBD694 24JBQ783
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.

Due to packaging discrepancy with incorrect product size mixed up.

ALCOIAILINMAMIMTNCNENYSDTXWY
▸Full report

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

Recall #:
98700
Lot/product code:
Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Airway Exam Kit, DYKE1796

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

ALL 50 STATES
▸Full report

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

Recall #:
98530
Lot/product code:
UDI-DI 10193489874716 (ea) 40193489874717 (case) Lots 24CBT023 24FBB701 24LBL343 25GBP141
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.

Due to packaging discrepancy with incorrect product size mixed up.

ALCOIAILINMAMIMTNCNENYSDTXWY
▸Full report

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

Recall #:
98700
Lot/product code:
Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

MEDLINE ANTERIOR HIP PACK DYNJ64672B

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

ALL 50 STATES
▸Full report

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

Recall #:
98530
Lot/product code:
UDI-DI 10195327377496 (EA) 40195327377497 (CS) LOT 23LMD300
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

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

Recall #:
98393
Lot/product code:
All products below with software version 8.2.2 through 8.5 are affected. 1. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416. 2. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581. 3. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312. 4. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140. 5. Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683. 6. Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440. 7. Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894. 8. Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425. 9. Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2026

Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

Drainable large pouch may leak due to manufacturing issue.

ALL 50 STATES
▸Full report

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

Recall #:
98455
Lot/product code:
UDI: 00768455221363 Lot: 5K01728
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled February 13, 2026

Rosabella brand MORINGA; DIETARY SUPPLEMENT CAPSULES; 60 capsules per bottle; Distributed by: Ambrosia Brands, LLC, 625 Randall Ave, St. 100, Cheyenne, WY 82001; SUGGESTED USE: As a dietary supplement, take two (2) veggie capsules once a day. For best results, take 20-30 min before a meal with an 8oz. glass of water or as directed by your health professional; UPC: 8 60012 16172 0

Product may be contaminated with Salmonella

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0546-2026
Lot/product code:
Lot # - Expiration Date: 5020591 - 03/2027 5020592 - 03/2027 5020593 - 03/2027 5020594 - 03/2027 5020595 - 03/2027 5020596 - 03/2027 5030246 - 04/2027 5030247 - 04/2027 5030248 - 04/2027 5030249 - 04/2027 5030250 - 04/2027 5030251 - 04/2027 5040270 - 05/2027 5040271 - 05/2027 5040272 - 05/2027 5040273 - 05/2027 5040274 - 05/2027 5040275 - 05/2027 5040276 - 05/2027 5040277 - 05/2027 5040278 - 05/2027 5040279 - 05/2027 5050053 - 6/2027 5050054 - 6/2027 5050055 - 6/2027 5050056 - 6/2027 5060069 - 07/2027 5060070 - 07/2027 5060071 - 07/2027 5060072 - 07/2027 5060073 - 07/2027 5060074 - 07/2027 5060075 - 07/2027 5060076 - 07/2027 5060077 - 07/2027 5060078 - 07/2027 5060079 - 07/2027 5060080 - 07/2027 5080084 - 9/2027 5080085 - 9/2027 5080086 - 9/2027 5090107 - 10/2027 5090108 - 10/2027 5090109 - 10/2027 5090113 - 10/2027 5090114 - 10/2027 5090115 - 10/2027 5090116 - 10/2027 5090117 - 10/2027 5090118 - 10/2027 5100039 - 11/2027 5100048 - 11/2027
Recalling firm:
Ambrosia Brands LLC
Resolved:
August 13, 2026
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 13, 2026

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

Failed Dissolution Specifications: This recall has been initiated due to an not meeting quality requirements finding in dissolution.

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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-0341-2026
Lot/product code:
Lot # 49261, Exp: 04/30/27
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

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

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 780G Insulin Pump: 763000411541, 763000441449, 763000523305, 763000521530, 763000521516, 763000533861, 763000544317, 763000734459, 763000758530, 763000758547, 763000578688, 763000734435, 763000504762, 763000734466, 763000924102, 763000924089, 763000454296, 763000854829, 763000411411, 763000411503, 763000384272, 763000411466, 763000411428, 763000411572, 763000411589, 763000411558, 763000384265, 763000411473, 763000411374, 763000411435, 763000411404, 763000384289, 763000411459, 763000411510, 763000411626, 763000411565, 763000411527, 763000411619, 763000411596, 763000411497, 763000411398, 763000411534, 763000411381, 763000384258, 763000411480, 763000411602, 763000411640, 763000411442, 763000441432, 763000442194, 763000521523, 763000442187, 763000521509, 763000521547, 763000578671, 763000596194, 763000639228, 763000639235, 763000639266, 763000974381, 763000974374, 763000921750, 763000921767, 763000921590, 763000921637, 763000933593, 763000891886, 763000921729, 763000921866, 763000921781, 763000921811, 763000921576, 763000921583, 763000921620, 763000921859, 763000891909, 763000921743, 763000944162, 763000921712, 763000921668, 763000933579, 763000933555, 763000933586, 763000933609, 763000921613, 763000933715, 763000933548, 763000944209, 763000891893, 763000933623, 763000933722, 763000933814, 763000933708, 763000933777, 763000933685, 763000933531, 763000933678, 763000933821, 763000933746, 763000933562, 763000944193, 763000533878, 763000734442, 763000854942, 763000914127: Medtronic MiniMed 780G with Instinct sensor System User Guide(M018856C024 2, M018857C035 2); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018857C034 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C004 2, M028792C004 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028792C015 1, M028792C001 3, M028792C002 1, M028792C006 1, M028792C003 1, M028792C005 1); Medtronic MiniMed 780G with Instinct sensor System User Guide(M018857C008 1, M018857C011 1, M018857C029 1, M018856C022 1, M018857C013 1, M018856C007 1, M018857C001 4, M018856C001 4, M018856C010 1, M018857C012 1, M018856C020 1, M018857C009 1, M018857C032 1, M018857C022 1, M018856C021 1, M018856C013 1, M018857C028 1, M018857C033 1, M018856C017 1, M018857C016 1, M018856C018 1); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018856C023 2, M018857C034 2); MiniMed 780G System Technical Guide(M075489C003 1, M075489C002 1, M075489C001 2); MiniMed 780G System User Guide(M072481C001 2); MiniMed 780G with Guardian 4 Sensor System User Guide mg(, M073070C003 1, M073070C001 2, M073070C002 1); MiniMed 780G with Guardian 4 Sensor System User Guide mm(M076019C002 1, M076019C001 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C003 1, M028790C002 1); MiniMed 780G system Changing the Medtronic Extended Infusion Set with Extended Reservoir(M048911C001 2, M048911C003 1, M048911C002 1); MiniMed 780G system Changing the MiniMed Mio Advance Infusion Set and Reservoir(M047607C001 1); MiniMed 780G system Changing the MiniMed Silhouette Infusion Set and Reservoir(M047610C001 1, M047610C003 1, M047610C002 1); MiniMed 780G system Changing the MiniMed Sure-T Infusion Set and Reservoir(M047609C001 1, M047609C003 1, M047607C003 1, M047607C002 1, M047609C002 1); MiniMed 780G System User Guide(M024832C003 2, M024829C004 2, M024832C004 2, M024829C005 2); MiniMed 780G System User Guide mg/dl(M014786C005 2, M014784C005 2, M014786C007 1, M014784C007 1, M014784C004 1, M014786C004 1, M014786C008 1, M014784C008 1, M014784C002 1, M014786C006 1, M014784C006 1, M014784C016 1, M014786C016 1, M014784C012 1, M014786C012 1, M014786C002 1, M014784C010 1, M014786C010 1, M014784C003 1, M014786C003 1, M014784C011 1, M014786C011 1, M014786C013 1, M014784C013 1, M014784C015 1, M014786C015 1, M014786C019 1, M014784C019 1); MiniMed 780G System User Guide mmol/L(M014787C002 1, M014785C002 1, M014785C007 2, M014787C007 1, M014787C005 1, M014785C005 1, M014787C006 1, M014785C006 1, M014785C023 2, M014787C023 2, M014787C010 1, M014785C010 1, M014787C011 1, M014785C011 1, M014787C021 1, M014785C021 1, M014787C008 1, M014785C008 1, M014785C009 1, M014787C009 1, M014787C022 1, M014785C022 1, M014785C027 1, M014787C027 1, M014787C004 2, M014785C004 2, M014785C003 1, M014787C003 1, M014785C030 1, M014787C030 1, M014785C013 2, M014787C013 2, M014785C019 1, M014787C019 1, M014785C020 1, M014787C020 1, M014787C018 1, M014785C018 1, M014787C012 1, M014785C012 1, M014787C016 1, M014785C016 1, M014787C024 1, M014785C024 1, M014785C014 2, M014787C014 1, M014787C028 1, M014785C028 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M060264C012 1, M060263C011 1, M060264C018 1, M060263C015 1, M060264C017 1, M060263C014 1, M060264C006 1, M060264C004 1, M060263C001 3, M060263C016 1, M060264C007 1, M060264C008 1, M060264C009 1, M060264C010 1, M060264C011 1, M060264C001 3, M060… (truncated, 6690 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.

ALL 50 STATES
▸Full report

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

Recall #:
98524
Lot/product code:
UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled February 13, 2026

Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 15mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt. 0.02 oz 2 TABLETS Supplement Facts 7-hydroxymitragynine 7.5 mg MANUFACTURED BY: Konig Products, LLC 30 N Gould Street, Suite R, Sheridan, WY 82801"; Packaging: Sealed silver metallic bag with a front and back sticker for the labels; Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 150mg total 7-Hydroxymitragynine per container (10 Packets x 2 Tablets Each) 7.5mg 7-OH per tablet/serving, LEMON DIETARY SUPPLEMENT Net Wt. 0.17 oz 10 PACKETS 2 TABLETS EACH Supplement Facts 7-hydroxymitragynine 7.5 mg MANUFACTURED BY: Konig Products, LLC 30 N Gould Street, Suite R, Sheridan, WY 82801"; Packaging: Sealed black flexible plastic bag with multi color sticker label on front and back UPC 810057763724

A sample of the product had the active ingredient in a quantity greater than the labeled specification.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1107-2026
Lot/product code:
B#AAW.501.3; all expiration dates
Recalling firm:
Shaman Botanicals, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 620G Insulin Pump (MMT-1750)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

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

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 620G Insulin Pump: 643169559745, 643169721319, 763000375461, 763000253189: Instr, Startup Guide, 620G 4.10, EN(6025951-022 1); INSTR., NGP 620G, BOLUS WIZARD, EN(6026006-023 1); Instr., 620G, Sftwr. 4.10, EN.(6026006-024 1); INSTRUCTIONS MMT-746EN PUMP 1510/1710 EN(7005933-023 1); DOC PKG MMT-746EN NGP 1710 EN(7005933-024 1); Startup Guide Assembly MMT-755EN(620G(M982438A021 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

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

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101: MiniMed 630G System(M020092C004 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1); MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1); MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1); MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1).
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

ALL 50 STATES
▸Full report

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

Recall #:
98186
Lot/product code:
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Real-Time Insulin Pump: 00613994409423, 00613994622600, 613994622747, 613994407733, 00613994407740, 00613994136374, 00613994271600, 00613994106476, 00613994373120, 00613994409478, 00613994312426, 00613994151780, 00885074419831, 00613994622747, 00613994951502, 00613994622648, 00643169026100, 00613994622624, 00613994622556, 00613994402011, 00613994409553, 00613994368485, 00613994368508, 00613994368522, 00613994108739, 00613994368607, 00613994368492, 00613994368515, 00613994123084, 00613994124814, 00613994402523, 00613994402530, 00613994402516, 00613994401502, 00613994402509, 00613994405913, 00613994123206, 00643169688421, 00643169199699, 00643169199675, 00613994409461, 00613994124777, 00643169572492, 00613994267177, 00643169848054, 00613994266897, 00613994310804, 00613994310798, 00613994310774, 00613994310903, 00613994401564, 00613994401663, 00613994402554, 00613994402462, 00613994402592, 00613994402608, 00613994405944, 00613994402455, 00613994402547, 00613994402479, 00763000069292, 00613994402578, 00613994409447, 00643169729438, 00763000069254, 00763000084325, 00613994402486, 00613994405920, 00763000069261, 00613994948595, 00613994929778, 00613994224569, 00613994929808, 00613994930361, 00613994929761, 00643169199705, 00643169199668, 00643169496248, 00643169848016, 00643169848023, 00763000161095,00613994123329, 00613994125026, 00613994247728, 00613994124692, 00613994124739, 00613994266903, 00613994267153, 00613994266880, 00613994267207, 00613994310866, 00613994310811, 00613994310781, 00613994310873, 00613994310613, 00613994310910, 00613994310880, 00613994310767, 00613994375025, 00613994368638, 00613994368553, 00613994368560, 00613994405937, 00613994368539, 00613994368546, 00613994377586, 00613994368591, 00613994368584, 00613994368577, 00613994402585, 00613994402561, 00613994401588, 00613994929815, 00643169221970, 00763000069247, 00763000090654, 00763000640163, 00613994601629, 00643169354975, 00613994401977, 00763000084332, 00643169919389, 00763000161118, 00763000161071: Artwork, CRB D Process, Instr, 522/722, NA(MP6025250-013DOC); Artwork, CRB D Process, Paradigm¿ 522 and 722 Insulin Pumps User(MP6025681-022DOC); Artwork, CRB A Process, Instr, 522/722,Block Mode,TST,Nordic,EN(MP6025681-023DOC); Artwork, CRB D Process, Instr, 522/722 with Enlite, OUS, EN(MP6025646-021DOC); Artwork, CRB D Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-022DOC); Artwork, CRB A Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-023DOC); Artwork, CRB A Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-023DOC); Artwork, New Product, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS(MP6025646-024DOC); Artwork, New Product, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS(MP6025646-024DOC); Artwork, New Product, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS - Nordic cover (MP6025681-024DOC);
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 13, 2026

Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT

Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.

ALL 50 STATES
▸Full report

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

Recall #:
98524
Lot/product code:
1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled February 13, 2026

Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 225mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt. 0.25 oz 30 TABLETS Supplement Facts 7-hydroxymitragynine 7.5 mg MANUFACTURED BY: Konig Products, LLC 30 N Gould Street, Suite R, Sheridan, WY 82801"; Packaging: White child-resistant plastic bottle with sticker label applied UPC 810057763779 (sometimes proceeded by 00)

A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.

ALL 50 STATES
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-1108-2026
Lot/product code:
B#AAW.501.3; all expiration dates
Recalling firm:
Shaman Botanicals, LLC
View official FDA record (opens in a new tab)