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Recalls affecting North Carolina

Data last updated: September 11, 2026 at 1:08 PM UTC

17,306 recalls found
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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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots: 20026497 20025590 20076421 21015406 21015407
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E; BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E; BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E; BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER VENTED/NONVENTED, REF: 82115E

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots: 20065590 20065591 20075066 20105945 20105946 20105947 20106408 21015533 21015552 20106612 20115540 21046676 20096121 20115539 21025938 21025939 21025940 21025941 21035175 21035176 20066404 21035174 20096120 20106171 20106172 20106173 20106174 20106175
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots: 20015114 20015115 20015116 20015117 20015118 20025813 20025814 20025815 20025816 20025817 20025818 20025819 20036187 20036188 20036259 20036260 20036261 20036262 20036327 20036328 20036329 20037133 20046569 20046570 20046615 20046616 20046617 20055967 20055968 20055984 20055985 20055986 20055987 20055988 20055989 20056364 20056365 20056366 20056452 20056453 20056565 20056566 20057064 20075232 20075235 20075616 20075617 20075238 20085525 20085526 20085774 20085775 20086097 20086098 20086099 20086100 20086101 20086102 20086427 20086428 20086429 20095126 20095127 20095128 20095129 20095130 20095131 20095146 20097042 20095147 20095148 20095150 20095151 20096880 20096881 20097041 20097043 20097044 20097045 20097046 20097047 20105605 20105606 20105607 20106571 20106572 20106573 20106677 20106678 20115001 20115002 20115003 20115004 20115005 20115006 20115007 20115008 20115009 20115010 20115011 20115012 20116408 20116409 20116410 20116411 20116815 20116961 20116830 20116831 20116832 20117063 20117064 20125036 20125037 20125245 20125246 20125247 20125248 20125249 20125250 20125454 20125455 20125456 20125457 20125518 20125519 20125520 20125589 20125590 20125591 20125628 20125629 20125630 20125631 20125632 20125633 20125634 20125635 20125636 20125637 20125638 21015733 21015734 21015735 21015736 21015876 21015877 21015737 21015878 21015879 21015989 21015990 21015991 21016007 21016025 21016026 21016056 21016057 21016058 21016232 21016391 21016392 21035751 21035752 21035753 21035757 21035758 21035754 21035755 21035756 21035759 21035760 21045887 21045888 21045889 21045890 21045891 21046137 21046139 21046140 21046574 21046581 21046656 21046673 21046672 21046717
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
UDI: 27613203013813; Lots: 21045673 21045672 21045671 21045670 21045669 21045243 21036889 21036844 21036767 21036766 21036698 21036697 21036696 21036695 21036643 21036642 21026547 21026546 21026545 21026379 21026378 21026377 21026327 21026326 21026325 21026324 21026323 21025283 21025282 21025281 21025280 21025279 21025278 21025157 21025156 21025155 21016751 21016394 21016393 21015306 21015305 20126555 20126554 20126553 20126552 20126529 20126528 20126527 20126526 20125986 20125985 20125984 20125983 20125982 20125981 20125980 20125979 20125978 20125977 20125976 20125975 20125974 20125973 20125972 20125950 20125949 20125948 20115023 20115022 20115021 20115020 20115019 20115018 20115017 20115016 20115015 20115014 20106570 20106231 20106230 20106229 20105085 20105084 20095138 20095137 20095136 20095135 20095134 20095133 20095132 20066719 20066718 20066717 20066448 20066447 20066446 20066231 20066230 20066229 20066228 20066109 20066108 20066107 20066106 20066105 20066104 20055332 20055331 20055330 20055329 20055080 20055079 20055078 20055077 20055076 20045843 20045842 20045841 20045840 20045839 20045838 20045837 20045836 20035578 20035577 20035496 20035495 20035494 20035493 20025024 20025023 20025022 20025021 20016446 20016445 20016444 20016443 20016442 20016317 20016316 20016315 20016194 20016193 20016192 20016191 20016190 20016105 20016104
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View; (7) Avance; (8) Avance CS2, GTIN 00840682102292; (9) Aisys; (10) Aisys CS2, GTIN 00840682102322; (11) Amingo; (12) 9100 NXT Config, Aelite NXT; (13) Protiva 7100;

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

ALL 50 STATES
▸Full report

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

Recall #:
88400
Lot/product code:
The flow sensors built prior to June 2021 that are installed in the devices/anesthesia machines.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20026597 20026598 20096477 20106218 20115237 20126022 20126023
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

ALL 50 STATES
▸Full report

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

Recall #:
88203
Lot/product code:
Lots:  20025450 20025451 20025452 20025531 20025532 20025533 20025534 20026527 20026529 20026532 20026533 20026534 20065580 20065582 20065581 20075239 20075240 20075241 20075242 20075618 20075619 20075447 20075448 20075449 20075450 20075451 20075452 20075453 20075790 20075791 20075924 20075792 20085362 20085363 20085364 20085365 20085421 20085422 20085522 20085523 20095302 20095303 20095310 20095533 20095534 20095311 20095312 20116500 20116501 21016470 21016471 21016593 20035697 20066252 20066399 20076260 20095373 20095887 20105859 20105860 20105861 20106710 21019903 21019904 21019905
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

ALL 50 STATES
▸Full report

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

Recall #:
88521
Lot/product code:
Model: 88000057 GTIN/UDI Codes: 06971576832026 / 01 06971576832026 240 88000057 21 200017 06971576832026 / 01 06971576832026 240 88000057 21 200023 06971576832026 / 01 06971576832026 240 88000057 21 200024 06971576832026 / 01 06971576832026 240 88000057 21 200036 06971576832026 / 01 06971576832026 240 88000057 21 200045 06971576832026 / 01 06971576832026 240 88000057 21 200047 06971576832057 / 01 06971576832057 240 88000057 21 230002 06971576832057 / 01 06971576832057 240 88000057 21 230003 06971576832057 / 01 06971576832057 240 88000057 21 230004 06971576832057 / 01 06971576832057 240 88000057 21 200059 06971576832057 / 01 06971576832057 240 88000057 21 230005 06971576832057 / 01 06971576832057 240 88000057 21 230006 06971576832057 / 01 06971576832057 240 88000057 21 230007 06971576832057 / 01 06971576832057 240 88000057 21 230008 06971576832057 / 01 06971576832057 240 88000057 21 230009 06971576832057 / 01 06971576832057 240 88000057 21 230010 06971576832057 / 01 06971576832057 240 88000057 21 230011 06971576832057 / 01 06971576832057 240 88000057 21 230012 06971576832057 / 01 06971576832057 240 88000057 21 230013 06971576832057 / 01 06971576832057 240 88000057 21 230014 06971576832057 / 01 06971576832057 240 88000057 21 230015 06971576832057 / 01 06971576832057 240 88000057 21 230016 06971576832057 / 01 06971576832057 240 88000057 21 230017 Serial Numbers: 200017; 200023; 200024; 200036; 200045; 200047; 230002; 230003; 230004; 200059; 230005; 230006; 230007; 230008; 230009; 230010; 230011; 230012; 230013; 230014; 230015; 230016; 230017;
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

ALL 50 STATES
▸Full report

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

Recall #:
88521
Lot/product code:
Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 3, 2021

Verigene EP Amplification Reagent Kit Test

There is potential for false positive results.

ALL 50 STATES
▸Full report

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

Recall #:
88423
Lot/product code:
Model: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023; Lots: 111620023A 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled August 3, 2021

Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.

Stronger than it should be Drug

ALL 50 STATES
▸Full report

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

Recall #:
D-0800-2021
Lot/product code:
Lot #:14218, Exp. Date 08/2022
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenSoyUndeclaredRecalled August 4, 2021

MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margarine, Light Corn syrup, Artificial Vanilla Flavor. ALLERGEN INFORMATION CONTAINS MILK, PECANS & MAY CONTAIN OTHER TREE NUTS. PRODUCED & DISTRIBUTED BY: MOLLY & ME PECANS LLC 9008 OLD STATE RD. HOLLY HILL, SC 29059

The firm was notified during an inspection by the State that the product contains not listed on the label soy.

ALARAZCACOFLGAILINKSKYMAMDMIMNNCNENJNVNYOHPASCTNTXVAVTWV
▸Full report

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

Recall #:
F-0858-2021
Lot/product code:
All date codes
Recalling firm:
Molly and Me Pecans
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

ALL 50 STATES
▸Full report

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

Recall #:
88421
Lot/product code:
19G0814 19G0824 19G0834 19G0844 19G0854 19G0864 19G0874 19G0894 19H0914 19H0924 19H0934 19H0944 19H0954 19H0964 19H0974 19H0984 19H0994 19H1014 19H1004 19H1024 19I1034 19I1054 19I1074 19I1084 19I1104 19I1114 19I1134 19I1144 19I1154 19J1184 19J1194 19J1204 19J1234 19J1244 19J1254 19J1284 19J1294 19J1304 19K1354 19L1364 19L1374 19L1384 20A0014 20A0024 20A0064 20A0034 20A0044 20A0054 20A0074 20A0084 20A0094 20A0104 20A0114 20A0124 20A0154 20A0144 20A0164 20A0184 20A0194 20B0204 20B0214 20B0224 20B0244 20B0234 20B0254 20B0264 20B0294 20B0274 20B0284 20B0304 20B0344 20B0314 20B0324 20B0394 20C0374 20B0334 20B0354 20B0364 20C0384 20C0414 20C0424 20C0454 20C0434 20C0444 20C0474 20C0464 20C0404 20C0484 20C0494 20C0504 20C0514 20C0524 20C0534 20C0544 20C0554 20C0564 20C0574 20C0584 20D0594 20D0604 20D0634 20D0644 20D0654 20D0664 20D0704 20D0714 20D0724 21D1014 20D0734 20D0744 20D0754 20D0764 20D0774 20E0824 20E0834 20E0844 20E0854 20E0864 20E0874 20E0914 20E0884 20E0894 20E0904 20E0924 20E0934 20E0974 20E0984 20E0994 20F1004 20F1014 20F1024 20F1034 20F1044 20F1074 20F1084 20F1094 20F1104 20F1124 20F1174 20F1134 20F1144 20F1184 20F1154 20F1164 20F1194 20F1214 20F1224 20G1284 20G1234 20G1244 20G1254 20G1294 20G1264 20G1314 20G1334 20G1344 20H1304 20H1354 20H1364 20H1374 20H1384 20H1394 20H1414 20H1424 20H1404 20H1434 20H1444 20H1494 20H1454 20H1464 20H1474 20H1484 20H1534 20H1544 20I1554 20I1564 20I1574 20I1624 20I1634 20I1644 20I1654 20I1664 20I1674 20I1684 20I1694 20I1704 20I1714 20I1764 20I1774 20J1784 20J1794 20J1804 20J1824 20J1834 20J1844 20J1854 20J1864 20J1914 20J1924 20J1934 20J1944 20J1954 20J2074 19J1324 20J2084 19J1334 20J2094 20K2144 20K2104 20K2114 19K1344 20K2164 20K2154 20K2174 20K2184 20K2194 20K2204 20K2224 20K2264 20K2274 20K2234 20K2284 20K2294 20K2304 20K2404 20K2344 20K2414 20K2424 20L2394 20L2434 20L2484 20L2494 20L2504 20L2474 20L2514 20L2524 20L2564 20L2604 20L2614 20L2574 20L2624 20L2634 20L2644 21A0014 21A0024 21A0034 21A0044 21A0054 21A0114 21A0124 21A0134 21A0144 21A0184 21A0194 21A0204 21A0214 21A0294 21B0304 21B0314 21B0324 21B0374 21B0384 21B0394 21B0404 21B0444 21B0454 21B0464 21B0474 21B0514 21B0524 21B0534 21C0544 21C0584 21C0594 21C0604 21C0614 21C0654 21C0664 21C0674 21C0684 21C0724 21C0734 21C0744 21C0754 21C0794 21C0804 21D0814 21D0824 21D0904 21D0914 21D0924 21D0934 21D1024 21D1034 21D1044 21E1114 21E1124 21E1134 21E1144 21E1244 21E1254 21E1264 21F1274 21F1414 21F1424 21F1434 21F1444 21F1524 21F1534 21F1544
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

ALL 50 STATES
▸Full report

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

Recall #:
88421
Lot/product code:
20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

ALL 50 STATES
▸Full report

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

Recall #:
88421
Lot/product code:
20I1524 20D0694 20I1584
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2021

Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

ALL 50 STATES
▸Full report

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

Recall #:
88483
Lot/product code:
Item Numbers: 1) 001205 (LiquaSonic Ultrasound Gel, 8.5oz) 2) 001222 (LiquaSonic Ultrasound Gel, 5L) 3) 30GB (EcoGel 100, 250ml, 12/cs) 4) 5005L4 (MAC EcoGel 5L, 4/cs) 5) 500812 (MAC EcoGel, 250ml, 12/cs) 6) M50008 (MediChoice Empty 8oz bottle) 7) M5005L4 (MediChoice USG 5L, 4/cs) 8) M500812 (MediChoice, 250ml, 12/cs) 9) 50TB (EcoGel High V TENS, 250ml) 10) 40JBB (EcoGel Multipurpose Ultrasound Gel, 250ml, 8oz, 12/cs) 11) 40JBHV-24 (EcoGel Blue High Velocity Ultrasound Gel, 250ml, 24/cs) 12) 40JMC (EcoGel 200 MultiPurpose Clear Ultrasound Gel 4-5ml Cubes with 4 dispenser bottles, 5L, 4/cs) 13) 20400 (MAC Ultrasound Gel Packet - Multipurpose) All lots shipped between 08/2018 and 08/2021.
Recalling firm:
Mac Medical Supply Co Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A899916, Lot NGFR0101, UDI (01)00801741074011(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A303318A, Lot NGEVX105, UDI (01)00801741073809(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A897514, Lot NGFR2808, UDI (01)00801741104510(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A943216, Lot NGEVX108, UDI (01)00801741100833(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A300314A, Lot NGFR3627, UDI (01)00801741073724(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A399400A, Lot NGFR3569, UDI (01)00801741073915(17)201228(10); Lot NGFR2691, UDI (01)00801741073915(17)201228(10)   Expanded 10/8/2021 adding Lot NGFR2691, UDI (01)00801741073915(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A902616, Lot NGFR3277, UDI (01)00801741104633(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
88499
Lot/product code:
Catalog A800365, Lots: NGFR3131, UDI (01)00801741073960(17)201220(10); NGFR3295, UDI (01)00801741073960(17)201220(10); NGFR4413, UDI (01)00801741073960(17)201220(10); NGFR4599, UDI (01)00801741073960(17)201220(10); and NGFS3150 UDI (01)00801741073960(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)