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Recalls affecting Hawaii

Data last updated: September 7, 2026 at 2:36 PM 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 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/virusAnnounced 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

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UnclassifiedBacteria/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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)
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UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

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▸Full report

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

Recall #:
99313
Lot/product code:
Model Number: 722400. UDI Number: (01)00884838042315(21)282, (01)00884838042315(21)206, (01)00884838042315(21)187, (01)00884838042315(21)486, (01)00884838042315(21)480, (01)00884838042315(21)71, (01)00884838042315(21)322, (01)00884838042315(21)506, (01)00884838042315(21)429, (01)00884838042315(21)413, (01)00884838042315(21)497, (01)00884838042315(21)507, (01)00884838042315(21)502, (01)00884838042315(21)222, (01)00884838042315(21)144, (01)00884838042315(21)510, (01)00884838042315(21)190, (01)00884838042315(21)43, (01)00884838042315(21)439, (01)00884838042315(21)176, (01)00884838042315(21)76, (01)00884838042315(21)364, (01)00884838042315(21)209, (01)00884838042315(21)382, (01)00884838042315(21)178, (01)00884838042315(21)243, (01)00884838042315(21)16, (01)00884838042315(21)110, (01)00884838042315(21)4, (01)00884838042315(21)101, (01)00884838042315(21)131, (01)00884838042315(21)93, (01)00884838042315(21)156, (01)00884838042315(21)347, (01)00884838042315(21)552, (01)00884838042315(21)482, 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(01)00884838042315(21)230.(01)00884838042315(21)548, (01)00884838042315(21)523, (01)00884838042315(21)299, (01)00884838042315(21)494, (01)00884838042315(21)286, (01)00884838042315(21)488, (01)00884838042315(21)541, (01)00884838042315(21)543, (01)00884838042315(21)427, (01)00884838042315(21)447, (01)00884838042315(21)344, (01)00884838042315(21)542, (01)00884838042315(21)262, (01)00884838042315(21)536, (01)00884838042315(21)469, (01)00884838042315(21)529, (01)00884838042315(21)554, (01)00884838042315(21)555, (01)00884838042315(21)546, (01)00884838042315(21)375, (01)00884838042315(21)534, (01)00884838042315(21)433, (01)00884838042315(21)463, (01)00884838042315(21)443, (01)00884838042315(21)483, (01)00884838042315(21)357, (01)00884838042315(21)374, (01)00884838042315(21)277, (01)00884838042315(21)530, (01)00884838042315(21)337, (01)00884838042315(21)549, (01)00884838042315(21)441, (01)00884838042315(21)320, (01)00884838042315(21)445, (01)00884838042315(21)287, (01)00884838042315(21)556, (01)00884838042315(21)446, (0… (truncated, 6927 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part Number AMS1217A; 6) Custom Pack - RX, Part Number AMS12757B; 7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700; 8) Arthrogram Tray - RX, Part Number AMS13755A; 9) Myelogram Tray - RX, Part Number AMS14805A; 10) Arthrogram Tray - RX, Part Number AMS15071A; 11) Vein Pack - RX, Part Number AMS15270; 12) Myelogram Tray - RX, Part Number AMS15298; 13) Loop Pack - RX, Part Number AMS15643; 14) Basic Biopsy Tray - RX, Part Number AMS15662A; 15) Pain Pack -RX, Part Number AMS17021; 16) Pain Tray -RX, Part Number AMS17817; 17) Vasectomy Pack - RX, Part Number AMS18226; 18) Arthrogram Tray- RX, Part Number AMS2886(A; 19) Custom Pack - RX, Part Number AMS3081C; 20) Basic Procedure Pack - RX, Part Number AMS5497; 21) Basic Pack - RX, Part Number AMS8130C; 22) Supply Kit - RX, Part Number AMS9521A; 23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB.

Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.

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

Recall #:
99347
Lot/product code:
Part Number AMS10164, UDI/DI B098AMS101640, Lot Numbers: 230816; Part Number AMS10276A, UDI/DI B098AMS10276A0, Lot Numbers: 230588, 230589, 230590, 230893, 241165; Part Number AMS10281B, UDI/DI B098AMS10281B0, Lot Numbers: 215784, 231259, 241171; Part Number AMS11398C, UDI/DI B098AMS11398C0, Lot Numbers: 230680; Part Number AMS1217A, UDI/DI B098AMS1217A0, Lot Numbers: 217313; Part Number AMS12757B, UDI/DI B098AMS12757B0, Lot Numbers: 240360; Part Number AMS13700, UDI/DI B098AMS137000, Lot Numbers: 217431; Part Number AMS13755A, UDI/DI B098AMS13755A0, Lot Numbers: 230376, 241103; Part Number AMS14805A, UDI/DI B098AMS14805A0, Lot Numbers: 217790; Part Number AMS15071A, UDI/DI B098AMS15071A0, Lot Numbers: 230689; Part Number AMS15270, UDI/DI B098AMS152700, Lot Numbers: 230667; Part Number AMS15298, UDI/DI B098AMS152980, Lot Numbers: 216398; Part Number AMS15643, UDI/DI B098AMS156430, Lot Numbers: 241219; Part Number AMS15662A, UDI/DI B098AMS15662A0, Lot Numbers: 241307; Part Number AMS17021, UDI/DI B098AMS170210, Lot Numbers: 230737, 231023; Part Number AMS17817, UDI/DI B098AMS178170, Lot Numbers: 241136; Part Number AMS18226, UDI/DI B098AMS182260, Lot Numbers: 241031; Part Number AMS2886(A, UDI/DI B098AMS2886(A0, Lot Numbers: 230745; Part Number AMS3081C, UDI/DI B098AMS3081C0, Lot Numbers: 230716; Part Number AMS5497, UDI/DI B098AMS54970, Lot Numbers: 230851; Part Number AMS8130C, UDI/DI B098AMS8130C0, Lot Numbers: 217634, 217635, 231235, 231236, 240963; Part Number AMS9521A, UDI/DI B098AMS9521A0, Lot Numbers: 217055; Part Number VK0003MB, UDI/DI 00813623010666, Lot Numbers: 217429.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

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

Recall #:
99276
Lot/product code:
UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
Recalling firm:
Paragon 28, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 16, 2026

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

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▸Full report

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

Recall #:
99083
Lot/product code:
ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.
Recalling firm:
Accuray Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 16, 2026

MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.

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▸Full report

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

Recall #:
99228
Lot/product code:
Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0
Recalling firm:
Medtronic MiniMed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 16, 2026

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

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

Recall #:
99109
Lot/product code:
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 16, 2026

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

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▸Full report

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

Recall #:
99075
Lot/product code:
All systems prior with software version 11X that utilize the Exchange Table
Recalling firm:
Accuray Incorporated
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 16, 2026

Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.

Weaker than it should be Drug

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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-0609-2026
Lot/product code:
Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.
Recalling firm:
The Harvard Drug Group LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 16, 2026

Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked with microbiological specimens derived by the human body for microbiological investigations. WebApp software is the user interface of WASPLab device.

Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.

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

Recall #:
99302
Lot/product code:
Lot Code: WebApp version 2.33.1, 2.33.3 and 2.34.2
Recalling firm:
Copan WASP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

Devices could potentially be occluded or partially occluded.

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

Recall #:
99284
Lot/product code:
REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.
Recalling firm:
Intersurgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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▸Full report

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045
Recalling firm:
TISSIUM SA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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▸Full report

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047
Recalling firm:
TISSIUM SA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Devices could potentially be occluded or partially occluded.

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

Recall #:
99284
Lot/product code:
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Recalling firm:
Intersurgical Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050
Recalling firm:
TISSIUM SA
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UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034
Recalling firm:
TISSIUM SA
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UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

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

Recall #:
99285
Lot/product code:
Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
Recalling firm:
Terumo Medical Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032
Recalling firm:
TISSIUM SA
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UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064
Recalling firm:
TISSIUM SA
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UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO1575; UDI-DI ¿03760279380087; Lot Number 250700007, 251000031, and 260300041
Recalling firm:
TISSIUM SA
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UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO2075; UDI-DI ¿03760279380100; Lot Number 250700016, 251000048, 251000049, and 260300043
Recalling firm:
TISSIUM SA
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Class IHigh risk
FoodBacteria/virusRecalled June 13, 2026

a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 860013251918

Product may be contaminated with Clostridium botulinum.

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

Recall #:
H-1137-2026
Lot/product code:
Recalled Lot Codes - 408125075E14F2 - 708125076E14F2 - 708125083E14F2 - 408125139E14F2 - 708125141E14F2 - 708125145E14F2 - 708125174E14F2 - 709125273E14F2 - 709125280E14F2 - 709125288E14F2 - 409125307E14F2 - 70926019ENNB - 70926029ENNB - 70926035ENNB - 70926039ENNB - 70926042ENNB Use-By dates span March 16, 2027 - February 11, 2028
Recalling firm:
NARA ORGANICS INC
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UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT, Catalog Number: DYKS1584; 7) GENERAL PREOP KIT, Catalog Number: DYKS1584A; 8) GENERAL PREOP KIT, Catalog Number: DYKS1584B

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

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

Recall #:
99334
Lot/product code:
1) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23KBL520; 2) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23LBP488; 3) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 25ABQ496; 4) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24CBI654; 5) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24DBU596; 6) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24FBA388; 7) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24GBD436; 8) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24JBC974; 9) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24KBA645; 10) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 23LBB037; 11) DYKS1216I, UDI-DI: 10198459362668(each), 40198459362669(case), Lot Number: 25GBP888; 12) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 25ABT088; 13) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24KBO407; 14) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24ABO808; 15) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24CBI736; 16) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24EBN336; 17) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24IBP255; 18) DYKS1583, UDI-DI: 10198459027666(each), 40198459027667(case), Lot Number: 24GBW364; 19) DYKS1584, UDI-DI: 10198459027659(each), 40198459027650(case), Lot Number: 24GBW365; 20) DYKS1584A, UDI-DI: 10198459146633(each), 40198459146634(case), Lot Number: 24JBA740; 21) DYKS1584B, UDI-DI: 10198459292750(each), 40198459292751(case), Lot Number: 25EBD220
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

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

Recall #:
99334
Lot/product code:
1) ACC010741, UDI-DI: 10195327515515(each), 40195327515516(case), Lot Number: 23KDB215; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBT847; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBB138
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

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

Recall #:
99334
Lot/product code:
1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24ABA808; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24BBV222; 3) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24GBT333; 4) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24IBU725; 5) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 23KBX578; 6) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 23LBP536; 7) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 25BMG311; 8) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24AME318; 9) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24BMI775; 10) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24CMJ550; 11) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24IMG215; 12) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 23JME381
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog Number: CDS983672P; 7) DYKM1982, Catalog Number: DYKM1982; 8) DYNDA1080, Catalog Number: DYNDA1080; 9) DYNJ67490C, Catalog Number: DYNJ67490C; 10) DYNJ907400D, Catalog Number: DYNJ907400D; 11) DYNJ908990A, Catalog Number: DYNJ908990A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

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

Recall #:
99334
Lot/product code:
1) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 2) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 3) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 4) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 5) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 6) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 7) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 8) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 9) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 10) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABM288; 11) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABR888; 12) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBB218; 13) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBM057; 14) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24FBH873; 15) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24HBG929; 16) CDS983348AB, UDI-DI: 10198459136986(each), 40198459136987(case), Lot Number: 25ABK077; 17) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24BBC413; 18) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24CBQ574; 19) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24IBC602; 20) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBC919; 21) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBK787; 22) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBL738; 23) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBB600; 24) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBE775; 25) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23JBR840; 26) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23KBM370; 27) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23LBD735; 28) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 25ABI289; 29) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 24LBO787; 30) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 25BBB356; 31) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 23LBU657; 32) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBF023; 33) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBL355; 34) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24KBA176; 35) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 25BBB185; 36) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24EBE506; 37) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24GBK362; 38) DYNJ67490C, UDI-DI: 10195327631710(each), 40195327631711(case), Lot Number: 24BBN881; 39) DYNJ907400D, UDI-DI: 10195327538552(each), 40195327538553(case), Lot Number: 24BBL947; 40) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25ALA775; 41) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25CLA341; 42) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24ILA196; 43) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24JLA337; 44) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24LLA178
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)