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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 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

View FDA’s announcement (opens in a new tab)
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 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.

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▸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

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 23, 2026

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35

Weaker than it should be Drug: Low not meeting quality requirements assay results performed during long-term stability testing.

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▸Full report

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

Recall #:
D-0677-2026
Lot/product code:
Lot #: 205060, Exp 09/30/2027
Recalling firm:
Padagis US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 23, 2026

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

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▸Full report

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

Recall #:
D-0723-2026
Lot/product code:
Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027.
Recalling firm:
Lupin Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2026

Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535.

Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

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

Recall #:
99383
Lot/product code:
REF/UDI-DI/Lot: 21-253519/00855967006035/24662119, 242162; 21-253522/00855967006042/24662122, 242163, 220702; 21-253525/00855967006059/24662125, 220703, 242164; 21-253528/00855967006066/24662128, 242165, 230704; 21-253530/00855967006073/242166, 230705, 220705; 21-253533/00855967006080/24662133, 242167, 230706; 21-253535/00855967006097/24662135, 242168, 230707; 21-253540/00855967006110/242169; 21-253545/00855967006127/242170; 21-253550/00855967006134/24662150; 21-353513/00855967006004/24662113, 242160; 21-353516/00855967006011/24662116, 230701, 242161; 27-253519/00855967006028/24662719, 242171; 27-253522/00855967006141/242172; 27-253525/00855967006158/242173; 27-253528/00855967006165/242174; 27-253530/00855967006172/242175; 27-253533/00855967006189/24662733, 242176; 27-253535/00855967006196/24662735, 242177
Recalling firm:
Arrowhead DE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2026

Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger. G4 PRO Black US - Refurb., SKU TG02428-01 G4 PRO NA, SKU G4-PRO-PKG-NA G4-PRO-PKG-US, SKU G4 PRO US G4 PRO Black US - Refurb V, SKU TG0002428-1V10 Pro Charger Single Unit, SKU PRO-CHARGER-SINGLE

Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating.

ALL 50 STATES
▸Full report

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

Recall #:
99281
Lot/product code:
UDI-DI 00810036050135 Charger GTIN 810036051378 All lots are recalled. Production ended in 2022.
Recalling firm:
Therabody, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 22, 2026

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

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-0617-2026
Lot/product code:
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
Recalling firm:
Direct Rx
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 19, 2026

Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.

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▸Full report

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

Recall #:
99236
Lot/product code:
UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 19, 2026

munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System

A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.

ALL 50 STATES
▸Full report

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

Recall #:
99328
Lot/product code:
Affected software versions: munevo DRIVE v1: 10.14.5 - 12.0.4; munevo DRIVE R-net: 10.17.5. - 12.0.4 UDI-DI 04260691380010 Units with affected features enabled: 2QNTGG2820170029, 2QNTGG2820170047, 2QNTGG2820160730, 2QNTGG2820161031, 1QNTGG2519120215, 1QNTGG2818520491, 1QNTGG2819210671, 2QNTGG2820160358, 2QNTGG2820170527, 2QNTGG2820160265, 2QNTGG2820160732, 1QNTGG2819200073, 2QNTGG2820160746, 2QNTGG2820160410, 2QNTGG2820160500, 2QNTGG2820160368, 2QNTGG2820161091, 2QNTGG2820161026, 2QNTGG2820160699
Recalling firm:
MUNEVO GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 19, 2026

Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 0567091

Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.

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▸Full report

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

Recall #:
99291
Lot/product code:
UDI-DI 00190790006570 Serial Numbers: 25C227687 25C228204 26C232382 26C233091 25C227688 25C228205 26C232383 26C233092 25C227689 26C231797 26C232384 26C233093 25C227690 26C231798 26C232709 26C233094 25C227691 26C231799 26C232710 26C233095 25C227692 26C231800 26C232711 26C233096 25C227693 26C231801 26C232712 26C233097 25C227694 26C232002 26C232713 26C233098 25C227695 26C232004 26C232714 26C233099 25C227696 26C232005 26C232715 26C233100 25C227697 26C232006 26C232716 26C233111 25C227698 26C232007 26C232717 26C233112 25C227699 26C232008 26C232718 26C233113 25C227700 26C232009 26C233032 26C233114 25C227701 26C232010 26C233033 26C233115 25C227702 26C232011 26C233035 26C233116 25C227703 26C232374 26C233036 26C233117 25C227704 26C232375 26C233037 26C233118 25C227707 26C232377 26C233038 26C233119 25C227708 26C232378 26C233039 26C233120 25C227709 26C232379 26C233040 26C233443 25C227710 26C232380 26C233041 26C233444 25C227711 26C232381 26C233090 26C233446 26C233448 26C234080 26C234360 26C234647 26C233449 26C234081 26C234361 26C234648 26C233450 26C234082 26C234362 26C234649 26C233451 26C234083 26C234363 26C234797 26C233452 26C234084 26C234364 26C234798 26C233692 26C234085 26C234566 26C234799 26C233693 26C234086 26C234567 26C234800 26C233694 26C234087 26C234630 26C234801 26C233695 26C234088 26C234631 26C234802 26C233696 26C234089 26C234632 26C234804 26C233697 26C234090 26C234633 26C234805 26C233698 26C234345 26C234634 26C234806 26C233699 26C234346 26C234635 26C234807 26C233700 26C234349 26C234636 26C234808 26C233701 26C234350 26C234637 26C234809 26C234071 26C234351 26C234638 26C234810 26C234072 26C234352 26C234639 26C234811 26C234073 26C234353 26C234640 26C234812 26C234074 26C234354 26C234641 26C234813 26C234075 26C234355 26C234642 26C234814 26C234076 26C234356 26C234643 26C234815 26C234077 26C234357 26C234644 26C234816 26C234078 26C234358 26C234645 26C235036 26C234079 26C234359 26C234646 26C235037 26C235038 26C235140 26C235437 26C235699 26C235039 26C235141 26C235438 26C235700 26C235040 26C235142 26C235439 26C235701 26C235041 26C235143 26C235440 26C235702 26C235042 26C235144 26C235441 26C235704 26C235043 26C235145 26C235442 26C235705 26C235044 26C235146 26C235443 26C236027 26C235045 26C235147 26C235444 26C236028 26C235046 26C235148 26C235445 26C236029 26C235047 26C235149 26C235446 26C236030 26C235048 26C235150 26C235447 26C236031 26C235049 26C235151 26C235686 26C236032 26C235050 26C235152 26C235687 26C236035 26C235051 26C235153 26C235688 26C236036 26C235052 26C235428 26C235689 26C236038 26C235053 26C235429 26C235691 26C236039 26C235054 26C235430 26C235692 26C236042 26C235055 26C235431 26C235693 26C236111 26C235134 26C235432 26C235694 26C236252 26C235135 26C235433 26C235695 26C236253 26C235136 26C235434 26C235696 26C235137 26C235435 26C235697 26C235138 26C235436 26C235698
Recalling firm:
Ferno-Washington Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodUndeclaredRecalled June 18, 2026

Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Vision of Health, Bell, CA 90201 UPC: PHF-C023

Dietary supplement product Vista MAX contains not listed on the label Yellow#5.

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-1135-2026
Lot/product code:
Lots: 509011; 506013; 409012; Expiration: 09/27; 06/27; 09/26
Recalling firm:
Provision Health Corp. dba PH Labs
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodUndeclaredRecalled June 18, 2026

Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Serving Size: 4 Capsules; Distributed by: L.A. Farmacia Natural, Burbank, CA 91504 UPC: PHF-C023

Dietary supplement product Ocular Plus contains not listed on the label Yellow#5.

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-1134-2026
Lot/product code:
Lots: 509011; 506013; 409012; Expiration: 09/27; 06/27; 09/26
Recalling firm:
Provision Health Corp. dba PH Labs
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) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.

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 AMS1095(E, UDI/DI B098AMS1095(E0; Lot Numbers: 231043; Part Number AMS11296A, UDI/DI B098AMS11296A0; Lot Numbers: 229846; Part Number AMS11314A, UDI/DI B098AMS11314A0; Lot Numbers: 216803, 240843; Part Number AMS11910A, UDI/DI B098AMS11910A0; Lot Numbers: 230645, 231078; Part Number AMS12171, UDI/DI B098AMS121710; Lot Numbers: 230958, 231238, 241232; Part Number AMS12219A, UDI/DI B098AMS12219A0; Lot Numbers: 217313; Part Number AMS12381B, UDI/DI B098AMS12381B0; Lot Numbers: 230948.
Recalling firm:
Windstone Medical Packaging, Inc.
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: SPINAL KIT, Part Number AMS13683A

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.

ALL 50 STATES
▸Full report

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

Recall #:
99347
Lot/product code:
UDI/DI B098AMS13683A0, Lot Number 230451
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number: 722059. 12. Allura Xper FD20/20; Model Number: 722038. 13. Allura Xper FD20/20 OR Table; Model Number: 722039. 14. Allura Xper R9 7 M12; Model Number: 722065. 15. Allura Xper R9 7 M20; Model Number: 722066. 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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FDA has not published a risk classification for this recall yet.

Recall #:
99313
Lot/product code:
1. Allura Xper FD10; Model Numbers (UDI Numbers): 722003 (N/A), 722010 ((01)00884838059030(21)754, (01)00884838059030(21)42, (01)00884838059030(21)500, (01)00884838059030(21)68, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)585, (01)00884838059030(21)641, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)667, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)359, (01)00884838059030(21)423, (01)00884838059030(21)1040, (01)00884838059030(21)478, (01)00884838059030(21)215, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)365, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)61, (01)00884838059030(21)477, (01)00884838059030(21)1078, 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(01)00884838059030(21)873, (01)00884838059030(21)274, (01)00884838059030(21)1391, (01)00884838059030(21)838, (01)00884838059030(21)999, (01)00884838059030(21)821, (01)00884838059030(21)170, (01)00884838059030(21)673, (01)00884838059030(21)683, (01)00884838059030(21)637, (01)00884838059030(21)784, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)638, (01)00884838059030(21)1112, (01)00884838059030(21)1373, (01)00884838059030(21)878, (01)00884838059030(21)1108, (01)00884838059030(21)830, (01)00884838059030(21)40, (01)00884838059030(21)39, (01)00884838059030(21)777, (01)00884838059030(21)608, (01)00884838059030(21)1260, (01)00884838059030(21)1052, (01)00884838059030(21)339, (01)00884838059030(21)447, (01)00884838059030(21)1250, (01)00884838059030(21)1147, (01)00884838059030(21)1034, (01)00884838059030(21)1421, (01)00884838059030(21)1258, (01)00884838059030(21)484, (01)00884838059030(21)626, (01)00884838059030(21)1332, (01)00884838059030(21)534, (01)00884838059030(21)868, (01)00884838059030(21)782, (01)00884838059030(21)985, (01)00884838059030(21)697, (01)00884838059030(21)707, (01)00884838059030(21)708, (01)00884838059030(21)1146, (01)00884838059030(21)1267, (01)00884838059030(21)891, (01)00884838059030(21)566, (01)00884838059030(21)569, (01)00884838059030(21)861, (01)00884838059030(21)1321, (01)00884838059030(21)1096, (01)00884838059030(21)906, (01)00884838059030(21)1366, (01)00884838059030(21)661, (01)00884838059030(21)872, (01)00884838059030(21)374, (01)00884838059030(21)243, (01)00884838059030(21)1428, (01)00884838059030(21)225, (01)00884838059030(21)812, (01)00884838059030(21)857, (01)00884838059030(21)1274, (01)00884838059030(21)598, (01)00884838059030(21)555, (01)00884838059030(21)844, (01)00884838059030(21)1285, (01)00884838059030(21)969, (01)00884838059030(21)1046, (01)00884838059030(21)1045, (01)00884838059030(21)31, (01)00884838059030(21)139, (01)00884838059030(21)928, (01)00884838059030(21)578, (01)00884838059030(21)1185, (01)00884838059030(21)28, (01)00884838059030(21)1374, (01)00884838059030(21)102, (01)00884838059030(21)126, (01)00884838059030(21)1050, (01)00884838059030(21)37, (01)00884838059030(21)1361, (01)00884838059030(21)1166, (01)00884838059030(21)915, (01)00884838059030(21)494, (01)00884838059030(21)884, (01)00884838059030(21)273, (01)00884838059030(21)146, (01)00884838059030(21)62, (01)00884838059030(21)994, (01)00884838059030(21)1113, (01)00884838059030(21)803, (01)00884838059030(21)802, (01)00884838059030(21)769, (01)00884838059030(21)192, (01)00884838059030(21)529, (01)00884838059030(21)743, (01)00884838059030(21)612, (01)00884838059030(21)528, (01)00884838059030(21)1334, (01)00884838059030(21)559, (01)00884838059030(21)141, (01)00884838059030(21)562, (01)00884838059030(21)570, (01)00884838059030(21)384, (01)00884838059030(21)811, (01)00884838059030(21)223, (01)00884838059030(21)552, (01)00884838059030(21)1326, (01)00884838059030(21)402, (01)00884838059030(21)875, (01)00884838059030(21)1117, (01)00884838059030(21)973, (… (truncated, 131098 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) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Number AMS3224.

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 AMS13975A, UDI/DI B098AMS13975A0, Lot Numbers: 230376, 241103; Part Number AMS2009, UDI/DI B098AMS20090, Lot Numbers: 216938, 240939; Part Number AMS3224, UDI/DI B098AMS32240, Lot Numbers: 231314.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF

Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

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

Recall #:
99299
Lot/product code:
Lot #0000369205/UDI: 00813307014232
Recalling firm:
Freudenberg Medical, LLC
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: Block Tray - RX, Part Number AMS12414

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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▸Full report

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

Recall #:
99347
Lot/product code:
UDI/DI B098AMS124140, Lot Numbers: 230411.
Recalling firm:
Windstone Medical Packaging, Inc.
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: Angio Pack - RX, Part Number AMS9461

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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▸Full report

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

Recall #:
99347
Lot/product code:
UDI/DI B098AMS94610, Lot Numbers: 230658, 231173.
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

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▸Full report

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

Recall #:
99299
Lot/product code:
Lot #0000369233/UDI: 00813307014133
Recalling firm:
Freudenberg Medical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

Ventriculostomy Kit, REF: 46154

Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.

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

Recall #:
99342
Lot/product code:
UDI-DI: 00673978947396, Lot: 2025-08779
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 17, 2026

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

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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-0628-2026
Lot/product code:
Lot AE01763, Expires 9/30/2027.
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2026

Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. 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:
1. Model Numbers (UDI Numbers): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)19, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)151, (01)00884838085275(21)137, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)59, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55), 722221 ((01)00884838099203(21)93, (01)00884838099203(21)108, (01)00884838099203(21)101, (01)00884838099203(21)124, (01)00884838099203(21)4, (01)00884838099203(21)106, (01)00884838099203(21)151, (01)00884838099203(21)71, (01)00884838099203(21)105, (01)00884838099203(21)60, (01)00884838099203(21)33, (01)00884838099203(21)55, (01)00884838099203(21)44, (01)00884838099203(21)74, (01)00884838099203(21)142, (01)00884838099203(21)144, (01)00884838099203(21)147, (01)00884838099203(21)96, (01)00884838099203(21)92, (01)00884838099203(21)78, (01)00884838099203(21)23, (01)00884838099203(21)133, (01)00884838099203(21)167, (01)00884838099203(21)26, (01)00884838099203(21)15, (01)00884838099203(21)163, (01)00884838099203(21)67, (01)00884838099203(21)81, (01)00884838099203(21)22). 2. Model Numbers (UDI Numbers): 722064 ((01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)513, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)479, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)502, (01)00884838085282(21)157, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)263, (01)00884838085282(21)264, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)102, (01)00884838085282(21)461, (01)00884838085282(21)510, (01)00884838085282(21)345, (01)00884838085282(21)185, (01)00884838085282(21)193, (01)00884838085282(21)271, (01)00884838085282(21)214, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)213, (01)00884838085282(21)180, (01)00884838085282(21)431, (01)00884838085282(21)354, (01)00884838085282(21)374, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)288, (01)00884838085282(21)231, (01)00884838085282(21)287, (01)00884838085282(21)150, (01)00884838085282(21)380, (01)00884838085282(21)233, (01)00884838085282(21)230, (01)00884838085282(21)44, (01)00884838085282(21)197, (01)00884838085282(21)176, (01)00884838085282(21)149, (01)00884838085282(21)289, (01)00884838085282(21)448, (01)00884838085282(21)82, (01)00884838085282(21)323, (01)00884838085282(21)35, (01)00884838085282(21)55, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)484, (01)00884838085282(21)36, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)422, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)439, (01)00884838085282(21)446, (01)00884838085282(21)138, (01)00884838085282(21)293, (01)00884838085282(21)292, (01)00884838085282(21)379, (01)00884838085282(21)321, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)208, (01)00884838085282(21)462, (01)00884838085282(21)342, (01)00884838085282(21)222, (01)00884838085282(21)391, (01)00884838085282(21)98, (01)00884838085282(21)441, (01)00884838085282(21)320, (01)00884838085282(21)494, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)311, (01)00884838085282(21)442, (01)00884838085282(21)485, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)384, (01)00884838085282(21)228, (01)00884838085282(21)91, (01)00884838085282(21)252, (01)00884838085282(21)73, (01)00884838085282(21)74, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)421, (01)00884838085282(21)400, (01)00884838085282(21)480, (01)00884838085282(21)387, (01)00884838085282(21)11, (01)00884838085282(21)48, (01)00884838085282(21)147, (01)00884838085282(21)509, (01)00… (truncated, 92750 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

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)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

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)