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Recalls affecting Hawaii

Data last updated: September 7, 2026 at 12:15 AM UTC

16,135 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Q6 Edge 2.0 (ilevel) 0060650920004*2 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Q6 Edge 4 0060650920028*8 K143383 D246699 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Q6 Edge 2.0 0060650920004*2 K042612 D049086 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0684-2026
Lot/product code:
Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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-0686-2026
Lot/product code:
Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2026

Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

ALL 50 STATES
Full report

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

Recall #:
99286
Lot/product code:
Lot Code: Quantum 1450 0060650920009*7 K112815 D143578 41875 ITI
Recalling firm:
Pride Mobility Products Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

ALL 50 STATES
Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 24, 2026

Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

Failed Impurities/Degradation Specifications

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-0664-2026
Lot/product code:
Lot #: 10162261, 10162262, 10162279, 10162280, Exp. Date 07/21/2026; 10162314, 10162315, Exp. Date 07/22/2026; 10162465, 10162466, 10162491, 10162492, Exp. Date 07/26/2026; 10162542, 10162543, Exp. Date 07/27/2026; 10162559, 10162560, Exp. Date 07/28/2026; 10162623, 10162624, Exp. Date 07/29/2026; 10162693, 10162694, Exp. Date 07/30/2026; 10162735, 10162736, 10162753, 10162754, Exp. Date 07/31/2026; 10162772, 10162773, 10162791, 10162792, 10162810, 10162811, Exp. Date 08/02/2026; 10162820, Exp. Date 08/03/2026; 10162853, 10162854, Exp. Date 08/04/2026; 10163046, Exp. Date 08/09/2026; 10163156, 10163157, Exp. Date 08/10/2026.
Recalling firm:
QuVa Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 24, 2026

Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01

Lack of Sterility Assurance

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-0673-2026
Lot/product code:
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Recalling firm:
Reliance Life Sciences Private Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 24, 2026

Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01

Lack of Sterility Assurance

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-0672-2026
Lot/product code:
Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
Recalling firm:
Reliance Life Sciences Private Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 24, 2026

Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01

Lack of Sterility Assurance

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-0671-2026
Lot/product code:
Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028
Recalling firm:
Reliance Life Sciences Private Limited
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900

Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

ALL 50 STATES
Full report

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

Recall #:
99359
Lot/product code:
Flow-i C20 6677200 / UDI-DI 07325710001349 Flow-i C30 6677300 / UDI-DI 07325710001363 Flow-i C40 6677400 / UDI-DI 07325710001318 Flow-i C20 6888520 / UDI-DI 07325710010617 Flow-i C30 6888530 / UDI-DI 07325710010624 Flow-i C40 6888540 / UDI-DI 07325710010631 Flow-c 6887700 / UDI-DI 07325710009765 Flow-e 6887900 / UDI-DI 07325710010457 Software versions 4.8, 4.10, and 4.11.
Recalling firm:
Maquet Critical Care AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

ALL 50 STATES
Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 20763000135700, Lot Numbers: 0232602300 0232602383 0232612916 0232680078 0232708967 0232709001 0232910880 0232910881 0232910882 0233077983 0233245850 0233245860 0233245980; UDI-DI: 00763000135706, Lot Numbers: 0232612916 0232709001
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

ALL 50 STATES
Full report

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

Recall #:
99390
Lot/product code:
S8698GX UDI-DI 20612479214716 Lot D5M3438FY
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 24, 2026

Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01

Lack of Sterility Assurance

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-0674-2026
Lot/product code:
Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027
Recalling firm:
Reliance Life Sciences Private Limited
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

ALL 50 STATES
Full report

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

Recall #:
99390
Lot/product code:
88861757-31 UDI-DI 10884521070912 Lot D6A3020FY UDI-DI 20884521070919 Lot D6A3020FY 88861799-31 UDI-DI 20884521071060 Lot D6A2861FY
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

ALL 50 STATES
Full report

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

Recall #:
99390
Lot/product code:
VLOCM0336 UDI-DI 20884521132501 Lot A5M0917VY VLOCM0436 UDI-DI 20884521827513 Lot A5M1035VY VLOCM0003 UDI-DI 10884521131606 Lot A5M1022VFY UDI-DI 20884521131603 Lots A5M1022VFY A5M1166VFY VLOCM0013 UDI-DI 10884521131644 Lot A5M1024VFY UDI-DI 20884521131641 Lots A5M1023VFY A5M1024VFY VLOCM0024 UDI-DI 10884521131699 Lot A5M0860VFY UDI-DI 20884521131696 Lot A5M0860VFY VLOCM0123 UDI-DI 20884521132235 Lot A5M1169VFY VLOCM0315 UDI-DI 20884521132464 Lot A6A1005VY VLOCM0603 UDI-DI 10884521132535 Lot A5M1246VY UDI-DI 20884521132532 Lot A5M1246VY VLOCM0604 UDI-DI 10884521132542 Lot A5M1062VY UDI-DI 20884521132549 Lots A5M1014VY A5M1062VY VLOCM1203 UDI-DI 10884521132757 Lot A6A1063VY UDI-DI 20884521132754 Lot A6A1063VY VLOCM2115 UDI-DI 20884521133003 Lot A5M1155VY
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

ALL 50 STATES
Full report

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

Recall #:
99390
Lot/product code:
BOX06614V4 UDI-DI 00199150037902 Lots 0233506453 0233506454 0233506455 0233506456 BOX07405V1 UDI-DI 00763000960186 Lot 0233617676 BOX01056V2 UDI-DI 00763000593711 Lot 0233484641 BOX01482V2 UDI-DI 00763000457990 Lot 0233607201 BOX09222V1 UDI-DI 00199150066636 Lot 0233577301 BOX08767V1 UDI-DI 00199150034338 Lot 0233598575 JAWBYPASS2 UDI-DI 00763000931988 Lots 0233608008 0233608009 BOX02191V11 UDI-DI 00199150038022 Lots 0233514888 0233586164 0233586169 0233587200 0234047180 BOX06863V4 UDI-DI 00763000991654 Lots 0233560359 0234087501 PST04884V3 UDI-DI 00763000523954 Lots 0233514943 0234035336 PST04884V6 UDI-DI 00763000646820 Lots 0233476937 0233550564 0233609032 BOX08506V2 UDI-DI 00199150028627 Lots 0234121845 0234122488 0234122495 0234122500 0234122505 0234122509 KIT00625V1 UDI-DI 00199150033874 Lot 0233646102 KIT01026V1 UDI-DI 00199150033867 Lot 0233646101 BOX00051V4 UDI-DI 00763000967765 Lots 0233560350 0233570153 0233584284 0233606897 PST03130V2 UDI-DI 00763000911096 Lot 0233628870 UCKGB5 UDI-DI 00763000910549 Lot 0233600730 WEJRYGB3 UDI-DI 00763000975326 Lot 0233547345 VLOCL0013 UDI-DI 20884521130361 Lot A5M1176VFY VLOCL0014 UDI-DI 20884521130378 Lot A6A0972VFY VLOCL0023 UDI-DI 20884521130408 Lot A5M1175VFY VLOCL0024 UDI-DI 20884521130415 Lot A5M1224VFY VLOCL0306 UDI-DI 10884521130944 Lot A6A0996VY UDI-DI 20884521130941 Lot A6A0996VY VLOCL0316 UDI-DI 10884521131316 Lot A5M1060VY UDI-DI 20884521131313 Lots A5M1060VY A6A0994VY VLOCL0345 UDI-DI 20884521131047 Lot A5M1165VY VLOCL0436 UDI-DI 20884521131085 Lot A5M1036VY VLOCL0604 UDI-DI 20884521131139 Lot A5M0869VY UDI-DI 10884521131132 Lots A5M0869VY A5M1179VY A5M1181VY A5M1182VY UDI-DI 20884521131139 Lots A5M0869VY A5M1179VY A5M1180VY A5M1181VY A5M1182VY VLOCL0615 UDI-DI 20884521131160 Lot A5M1245VY VLOCL0625 UDI-DI 20884521131238 Lot A6A1000VY VLOCL0644 UDI-DI 20884521131269 Lot A5M1163VY VLOCL0804 UDI-DI 10884521131286 Lots A5M1064VY A5M1205VY UDI-DI 20884521131283 Lots A5M1064VY A5M1205VY A6A1004VY VLOCL2105 UDI-DI 10884521131538 Lot A6A1003VY UDI-DI 20884521131535 Lots A5M1183VY A6A1003VY VLOCL2145 UDI-DI 10884521131545 Lot A6A1001VY UDI-DI 20884521131542 Lots A5M1164VY A6A1001VY VLOCL2246 UDI-DI 20884521762494 Lot A6A0998VY
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

ALL 50 STATES
Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 20763000135632, Lot Numbers: 0232446429 0232446444 0232486752 0232601515 0232601516 0232601522 0232601586 0232601591 0232601593 0232602180 0232798265 0232798353 0232849583 0232894981 0232895082 0232902694 0232902697 0232902698 0232902700 0232902803 0232902805 0232902846 0232985469 0233009922 0233108251 0233116991 0233127352 0233334923 0233334966 0233426694 0233426695 0233528727; UDI-DI: 00763000135638, Lot Numbers: 0232446444 0232798353 0232895082 0232902697 0232902803 0232902846 0232985469 0233127352 0233334923
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

ALL 50 STATES
Full report

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

Recall #:
99390
Lot/product code:
SP-623 UDI-DI 20884521037073 Lot D6A2963Y
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

ALL 50 STATES
Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 24, 2026

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

ALL 50 STATES
Full report

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

Recall #:
D-0732-2026
Lot/product code:
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Recalling firm:
JB Chemicals and Pharmaceuticals Ltd
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled June 24, 2026

High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear plastic container. UPC on retail container: 0 952348 80170 0. The label of affected product declares: INGREDIENTS: MILK CHOCOLATE (SUGAR, ***WHOLE MILK POWDER, SOY LECITHIN ***RAISINS***CONTAINS MILK AND SOY*** Distributed by Lehi Valley Trading Company of Mesa, AZ.

Not listed on the label Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended not listed on the label peanut due to mis-packaging.

ALL 50 STATES
Full report

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

Recall #:
H-1150-2026
Lot/product code:
Lot # 0160933 Best by date of Jan 23, 2027
Recalling firm:
Lehi Valley Trading Company, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

ALL 50 STATES
Full report

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

Recall #:
99320
Lot/product code:
UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2026

BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Due to increase in false negative results

ALL 50 STATES
Full report

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

Recall #:
99261
Lot/product code:
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
Recalling firm:
BioFire Diagnostics, LLC
View official FDA record (opens in a new tab)