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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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

▸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 Alive — Moringa 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. Braun — 0.9% 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 Value — Organic 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

Lipofit — Lipofit 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

Kofinas — Garlic 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 Temptations — Chocolatey 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 Sprouts — Robust 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

Martina — Mangoes

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)

Recalls nationwide

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

19,224 recalls found
NewestOldest
High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
DYNDH1487A UDI-DI 10193489484311 Lots 25AMD225 25BMA495 25GMD834 25HMJ685 26AMD781 26DMI370 26FMG952 26FMJ739
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

ALL 50 STATES
▸Full report

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

Recall #:
99404
Lot/product code:
Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491
Recalling firm:
Midmark Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
UDI-DI 10889942925858 Lot 26EBI940
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
DYKS1583A UDI-DI 10198459146640 Lot 24KBP388
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

ALL 50 STATES
▸Full report

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

Recall #:
99404
Lot/product code:
Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491
Recalling firm:
Midmark Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
CDS981762B UDI-DI 10193489306767 Lots 24JBE456 24JBN932 24KBJ154 25ABK513 25CBL684 25HBK086 25IBM188 25KBL720 25LBF812 25LBU497 26ABM665 26CBH544 26CBT272 26FBK806 DYKA1054F UDI-DI 10193489312607 Lots 24ILA823 24JLA285 24LLA226 24LLB033 25BLA842 25ELA624 25GLA270 25HLB055 25KLA019 25KLA187 26BLA150 26CLA717 26DLA410 26ELA772 26FLA756
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

ALL 50 STATES
▸Full report

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

Recall #:
99404
Lot/product code:
Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901
Recalling firm:
Midmark Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
UDI-DI 10193489431070 Lots 25BBB005 25GBY063 25KBI862 25LBT688 26CBG211
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DYLAB1081 FLOORS BLOOD DRAW KIT DYLAB1080 PEDS BLOOD CULTURE KIT DYNDH1445C PERIPHERAL BLOOD CULTURE KIT DYNDH2350 WICHITA BLOOD CULTURE COLLECT DYNDH2093

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
DYNDH1444D UDI-DI 10195327502492 Lots 24IBK133 24KBE072 24LBD419 25GBT189 25IME347 25IMI389 25KMA880 25KME693 26BMH685 26CMH411 26DME199 26EMB070 26EMF542 26FMC275 DYNDH1866 UDI-DI 10195327400958 Lots 24HBW237 24IBI505 24JBI308 24KBH534 24LBI545 25ABC487 25ABO282 DYNDH1462B UDI-DI 10195327662462 Lots 24HBV192 24IBE469 24IBV947 24JBA557 24JBI310 24KBJ830 24KBJ831 24KBN934 24LBN283 24LBP258 DYNDH1622C UDI-DI 10195327509873 Lots 24IBE381 24IBL908 24JBF575 24JBS022 24KBN937 24LBI552 DYNDH1622D UDI-DI 10198459234965 Lots 25GBA905 25GBI398 25GBT182 25HBN203 25IBH345 25IBQ486 25IBS192 25JBN629 25KBK718 25LBI568 DYNDH1622F UDI-DI 10198459658884 Lots 26BBL477 26CBA407 26CBD376 26DBA855 26DBL286 26FBF458 DYNDH1715B UDI-DI 10195327407094 Lot 24IMF148 DYNDH2028 UDI-DI 10198459035715 Lot 24KBL250 DYNDH2048 UDI-DI 10198459106125 Lots 24JBK987 25GBI401 25GBT183 25IBB666 25JBC742 25KBD093 25KBK723 25LBI567 25LBO863 26ABL653 26CBO165 26DBB153 26DBE994 26EBF752 26FBN334 DYNDH2089 UDI-DI 10198459244070 Lots 25KMJ967 26BMI731 26FMF126 DYLAB1081 UDI-DI 10198459199608 Lots 24LMH506 25HMA386 25HMD685 25IMF415 25JMB438 25JMC503 26AML138 26BMJ277 26EMB352 DYLAB1080 UDI-DI 10198459199615 Lots 24LMG085 25AMH560 DYNDH1445C UDI-DI 10195327502614 Lots 24IBK131 24KBB551 24LBU139 25GBQ023 25GBU016 25HMI515 25IMB465 25IME350 25JMI247 26CMB609 26DMH686 26FMC274 26FMC274D DYNDH2350 UDI-DI 10198459779251 Lot 26FBM766 DYNDH2093 UDI-DI 10198459256967 Lot 26ABP408
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled July 19, 2026

Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 capsules per day. Route of Administration: OraI. Manufactured for Zen Principle 774 Mays Blvd Incline Village, NV 89451. The product is offered as a 1-pack (180 capsules; Amazon code/FNSKU X000ZJJ4FT) and as a 2-pack (twin pack, 360 capsules; Amazon code/FNSKU X00159YJXP).

Possible Salmonella in Moringa Leaf Powder product.

NV
▸Full report

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

Recall #:
H-1222-2026
Lot/product code:
LOT: A6FF4, Best By: 11/2028
Recalling firm:
FACTORY6, INC.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 18, 2026

Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfast Burrito Net Wt. 8.2 oz (232g) UPC 1 00001 00029 7 and Sprig & Sprout Spicy Breakfast Burrito IN A SPICY TORTILLA NET WEIGHT 8.3oz (234g) Contains: Egg, Milk, Wheat. MG Foods Charlotte, NC 28272

Not listed on the label Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.

ALGAKYNCSCTNVAWV
▸Full report

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

Recall #:
H-1192-2026
Lot/product code:
Fresh Thru: 07/20/26
Recalling firm:
M.G. Foods, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2026

Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

Presence of Particulate Matter; identified as stainless steel

ALL 50 STATES
▸Full report

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

Recall #:
D-0744-2026
Lot/product code:
Lot # V24010V1, Exp 3/31/2027
Recalling firm:
Sunny Pharmtech Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2026

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

Presence of Particulate Matter; identified as stainless steel

ALL 50 STATES
▸Full report

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

Recall #:
D-0743-2026
Lot/product code:
Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Recalling firm:
Sunny Pharmtech Inc.
View official FDA record (opens in a new tab)
Not Yet ClassifiedRisk not yet known
FoodBacteria/virusRecalled July 17, 2026

MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

ALARCTFLGAIAILINKSKYLAMAMDMIMOMSNCNHNJOHOKPASCTNTXVAWI
▸Full report

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

Recall #:
Lot/product code:
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# TFMX183A05 7/21/2026 TFMX184A02 7/22/2026 TFMX187B02 7/25/2026 TFMX189A03 7/27/2026 TFMX190A03 7/28/2026 TFMX190B01 7/28/2026 TFMX191A02 7/29/2026 TFMX194B02 8/1/2026
Recalling firm:
Taylor Farms de Mexico S. de R.L. de C.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2026

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

ALL 50 STATES
▸Full report

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

Recall #:
99450
Lot/product code:
UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
Recalling firm:
Remel Europe Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 16, 2026

Flexible food pouch (3-layer foil, spouted, #CP6088), manufactured for packaging Pumpkin Tree Peter Rabbit Organics Banana & Strawberry, 4 oz food puree, UPC 815367010780.

Flexible food pouch may release thin plastic strips into food.

OR
▸Full report

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

Recall #:
H-1193-2026
Lot/product code:
Food pouch (3-layer foil, spouted, Cheer Pack Part#CP6088) manufactured for packaging food products. Customer Part #31720. Manufacture date 10/25/25 - 10/31/25. Lot Numbers: LSS20100005297, LSS2010000598, LSS20100005300, LSS20100005301, LSS 20100005302, LSS20100005303, LSS20100005304, LSS2015306, LSS20100005307, LSS20100005308, LSS20100005309, LSS20100005310.
Recalling firm:
CHEER PACK
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0737-2026
Lot/product code:
Lot: 25141583, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

ALL 50 STATES
▸Full report

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

Recall #:
99422
Lot/product code:
UDI: (01)00884838099258(21)1229, (01)00884838099258(21)450, (01)00884838085251(21)302, (01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)1578, (01)00884838099241(21)324, (01)00884838099241(21)585, (01)00884838099241(21)332, (01)00884838099258(21)750, (01)00884838099241(21)312, (01)00884838099241(21)85, (01)00884838099258(21)409, (01)00884838085268(21)1023, (01)00884838099272(21)125, (01)00884838099272(21)127, (01)00884838099272(21)126, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099258(21)295, (01)00884838099272(21)124, (01)00884838099272(21)120, (01)00884838099258(21)277, (01)00884838099258(21)262, (01)00884838099258(21)261, (01)00884838099258(21)272, (01)00884838099258(21)275, (01)00884838085367(21)547, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838085251(21)585, (01)00884838099258(21)1315, (01)00884838085268(21)645, (01)00884838085251(21)410, (01)00884838085268(21)646, (01)00884838099258(21)3526, (01)00884838099258(21)2744, (01)00884838099258(21)3698, (01)00884838099258(21)959, (01)00884838099258(21)381, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838099258(21)1371, (01)00884838099241(21)533, (01)00884838085268(21)1387, (01)00884838099272(21)153, (01)00884838099258(21)1019, (01)00884838085268(21)460, (01)00884838099258(21)260, (01)00884838085251(21)753, (01)00884838085268(21)35, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838099272(21)67, (01)00884838099258(21)1049, (01)00884838099258(21)3045, (01)00884838099258(21)3044, (01)00884838099258(21)3107, (01)00884838099258(21)2258, (01)00884838099258(21)1484, (01)00884838099272(21)209, (01)00884838099258(21)2573, (01)00884838099258(21)3514, (01)00884838099258(21)1083, (01)00884838099258(21)3314, (01)00884838085268(21)703307, (01)00884838099258(21)2436, (01)00884838099258(21)2184, (01)00884838099241(21)479, (01)00884838099272(21)271, (01)00884838099241(21)189, 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(01)00884838099272(21)1145, (01)00884838099272(21)1078, (01)00884838085268(21)703559… (truncated, 294787 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 July 16, 2026

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications.

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

Recall #:
99423
Lot/product code:
UDI: (01)00884838116757(21)5, (01)00884838116771(21)686, (01)00884838116771(21)521, (01)00884838116771(21)812, (01)00884838116771(21)163, (01)00884838116801(21)127, (01)00884838116757(21)34, (01)00884838116733(21)61, (01)00884838116764(21)226, (01)00884838116771(21)327, (01)00884838116764(21)277, (01)00884838116771(21)780, (01)00884838116771(21)429, (01)00884838116764(21)276, (01)00884838116788(21)87, (01)00884838116801(21)37, (01)00884838116771(21)362, (01)00884838116771(21)502, (01)00884838116740(21)77, (01)00884838116757(21)106, (01)00884838116771(21)222, (01)00884838116771(21)545, (01)00884838116801(21)159, (01)00884838116801(21)345, (01)00884838116771(21)987, (01)00884838116771(21)457, (01)00884838116801(21)136, (01)00884838116757(21)49, (01)00884838116771(21)803, (01)00884838116771(21)901, (01)00884838116771(21)347, (01)00884838116764(21)335, (01)00884838116801(21)199, (01)00884838116801(21)24, (01)00884838116771(21)902, (01)00884838116771(21)529, (01)00884838116764(21)99, 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(01)00884838116771(21… (truncated, 50974 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)
Class IIModerate risk
DrugRecalled July 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

Presence of Particulate Matter: Hair was found in products

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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-0728-2026
Lot/product code:
Lot #: 6130235, Exp. Date 02/2027
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Presence of Particulate Matter: Hair was found in product

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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-0725-2026
Lot/product code:
Lot #: 6134349, 6134620 Exp. Date 11/2026
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0738-2026
Lot/product code:
Lot: 25141585, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

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

Recall #:
99459
Lot/product code:
Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
Recalling firm:
Biofire Defense
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

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

Recall #:
99441
Lot/product code:
UDI/DI 7630031707055, Lot ZVFV5
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

Presence of Particulate Matter: Hair was found in products

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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-0726-2026
Lot/product code:
Lot #: 6133801, Exp. Date 01/2028
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)