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Recalls affecting Louisiana

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

16,895 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
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 AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
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. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
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 ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
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

Full report
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 TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
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 SproutsRobust Radish Mix, 5oz Cups

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

Full report
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

MartinaMangoes

Potential contamination with Salmonella

Full report
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 18, 2026

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Stability Data Does Not Support Expiry Date.

ALL 50 STATES
Full report

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

Recall #:
D-0387-2026
Lot/product code:
Lot #: 795CP-0005, Exp. Date 06/30/2026
Recalling firm:
HTO Nevada Inc. dba Kirkman
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenSesameUndeclaredRecalled February 18, 2026

Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522

Not listed on the label sesame seed ingredient in hamburger buns.

ALL 50 STATES
Full report

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

Recall #:
H-0603-2026
Lot/product code:
Expiration date: 02/24/2026
Recalling firm:
NRS Enterprises, Inc. dba Sunflour Bakery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.

ALL 50 STATES
Full report

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

Recall #:
98529
Lot/product code:
UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
Full report

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

Recall #:
98482
Lot/product code:
UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
Full report

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

Recall #:
98482
Lot/product code:
UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
Full report

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

Recall #:
98482
Lot/product code:
UDI(s):10081317028427 10081317028434 10081317028458 10081317028465
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
Full report

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

Recall #:
98482
Lot/product code:
10081317028335
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
Full report

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

Recall #:
98482
Lot/product code:
00081317006671 00081317006794 00081317006800
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
Full report

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

Recall #:
D-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.

ALL 50 STATES
Full report

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

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

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

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

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)
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
Full report

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

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.

ALL 50 STATES
Full report

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: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 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

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. 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

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 13, 2026

Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

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 Revel Insulin Pump: 00613994951502, 00763000161262, 00613994743930, 00643169077737, 00613994904485, 00643169202399, 00643169151369, 00643169478602, 00643169513914, 00643169933170, 00763000161132, 00643169464520: Artwork, CRB D Process, Paradigm REAL-Time Revel Insulin Pump UG (MP6025306-011A 1); Artwork, CRB D Process, Instr, X23 revel, EN (MP6025306-019 1)
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 IIModerate risk
DrugRecalled February 13, 2026

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

ALL 50 STATES
Full report

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

Recall #:
D-0380-2026
Lot/product code:
Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
Recalling firm:
Harbin Jixianglong Biotech Co., Ltd.
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)