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Recalls affecting Louisiana

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

16,930 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

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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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
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)

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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)
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.

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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/virusSalmonellaAnnounced 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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116

Missing splash guard which may expose users to hazardous materials. .

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

Recall #:
88615
Lot/product code:
Catalog Number: A88116 - 3K HS Refrigerated Stockyard UDI: 15099590591960 Serial Numbers: 90HF1304006; 90HF1306009; 90HF1303005; 90HF1508005; 90HF1302005; 90HF1610005; 90HF1806001; 90HF1209005; 90HF1303007; 90HF1708006; 90HF1205001; 90HF1805002; 90HF1402005; 90HF1503001; 90HF1104002; 90HF1208004; 90HF1208005; 90HF1203001; 90HF1012004; 90HF1101002; 90HF1702003; 90HF1402004; 90HF1303008; 90HF1210001; 90HF1207001; 90HF1305007; 90HF1305004; 90HF1610001; 90HF1505002; 90HF1307005; 90HF1610002; 90HF1508003; 90HF1210002; 90HF1306001; 90HF1206002; 90HF1208002; 90HF1305008; 90HF1009002; 90HF1101001; Catalog Number: 6915556 - Power Processor 3K Stockyard (Stockyard 3000/R Kit for PWR PROC) Serial Numbers: 90AM0805001; 90AM0902009; 90AM0902005; 90AM0806003; 90AM0801003; 90AM0802002; 90AM0803001; 90AM0912002; 90AM1003002; 90AM0905010; 90AM0801004; 90AM06007008; 90AM060703; 90AM060704; 90AM0710002; 90AM0905007; 90AM0710008; 90AM0903002; 90AM0808002; 90AM0711004; 90AM0711005; 90AM0810001; 90AM0901002; 90AM0905006; 90AM0904004; 90AM0904005; 90AM0803002; 90AM0710004; Amended - additional Products and Codes (12/15/2021): B05520 - Stockyard, 5K HS, Refrigerated Serial Numbers: 90HG1104002; 90HG1101001; 90HG1105002; 90HG1104001; 90HG1101003; 90HG1101002; 90HG1202004; 90HG1102005; 90HG1101004; 90HG1206002; A88115 - 5K HS Refrig Stockyard Serial Numbers: 90HG0911001 90HG0911003 90HG0911002
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

ALL 50 STATES
▸Full report

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

Recall #:
88362
Lot/product code:
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Recalling firm:
Roche Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

ALL 50 STATES
▸Full report

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

Recall #:
88362
Lot/product code:
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Recalling firm:
Roche Diabetes Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 28, 2021

Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

ALL 50 STATES
▸Full report

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

Recall #:
88362
Lot/product code:
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Recalling firm:
Roche Diabetes Care, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 29, 2021

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

Defective container: possibility for lack of seal integrity.

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-0769-2021
Lot/product code:
Lot #: 14892, Exp 1/2022
Recalling firm:
Teligent Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2021

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

ALL 50 STATES
▸Full report

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

Recall #:
90603
Lot/product code:
Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Recalling firm:
Mizuho OSI
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2021

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

Failed Stability Specifications; not meeting quality requirements for shear.

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-0724-2021
Lot/product code:
Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Recalling firm:
Noven Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2021

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

Failed Stability Specifications; not meeting quality requirements for shear.

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-0725-2021
Lot/product code:
Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
Recalling firm:
Noven Pharmaceuticals Inc
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 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

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

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 SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006

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:  20066502 20066503 20066504 20076251 20076352 20086483 20086484 20086485 20086486 20087129 20087130 20096280 20096281 20096282 20096283 20097163 20105074 20105075 20095374 20095375 20096302 20105754 20105755 20105756 20105757 20105758 20115470 21036462 21036463 21036464 21036465 21036466
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D

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:  20025240 20025241 20025242 20056225 20056231 20056229 20056230 21025820 21025823 21025824 21025825 21025829 20036690 20036691 20036692 20036694 20036983 20046920 20046921 20046922 20055220 20055221 20055222 20055223 20055379 20055380 20055381 20055382 20055503 20055504 20055505 20055506 20055507 20055508 20055880 20055881 20055882 20055883 20055884 20055885 20055886 20055887 20055888 20055889 20055890 20065100 20065101 20065102 20065104 20065103 20065105 20065106 20065107 20065108 20065109 20065110 20065111 20065986 20065987 20065988 20065989 20066898 20066936 20066937 20066938 20066939 20066940 20067172 20075176 20075177 20075481 20075482 20075623 20075483 20075484 20075624 20075625 20075793 20075794 20076070 20076071 20076486 20076487 20076488 20076489 20076490 20076491 20076576 20076577 20076578 20076686 20076687 20076769 20076770 20076771 20076772 20076773 20076774 20077355 20077356 20077357 20077358 20077359 20077360 20077361 20077362 20077363 20077364 20085089 20085090 20085091 20085092 20085289 20085290 20085291 20085366 20087446 20087447 20087448 20095317 20095318 20105086 20105087 20105088 20105089 20105571 20105572 20105993 20106356 20106357 20106358 20106359 20106360 20106361 20106362 20106363 20106364 20106402 20106403 20106404 20106405 20106406 20106407 20106727 20115182 20115183 20115184 20115186 20115205 20115207 20115208 20115181 20115533 20115203 20115534 20116576 20116577 20116578 20116579 20116580 20116581 20116582 20116583 20116584 20116585 20116586 20116587 20116588 20116589 20116590 20116591 20116592 20116593 20116594 20116595 20126194 20126195 20126196 20126197 20126198 20126249 20126250 20126251 20126252 20126253 20126254 20126255 21015660 21015661 21015724 21015725 21015753 21015754 21015775 21015776 21015777 21015778 21015897 21015898 21015899 21015900 21015901 21016150 21016151 21015902 21016152 21015896 21035775 21035776 21035777 21035778 21035779 21035780 21035781 21035782 21036838 21036839 21036840 21036841 21036842 21036874 21045277 21045278 21045279 21045280 21045281 21045282 21045284 21045285 20026035 20026036 20056669 20056670 20056671 20066232 20066233 20066234 20066235 20115387 20115388 20115389 20115390 20115391 20125048 20125334 20125313 20125314 21015747 21015748 21015933 21015934 21045416 21045415 21045417 20026037 20026038 20026039 20045035 20097181 20097182 20115384 20115385 20115386 20125332 20125333 20126421 20017143 20017144 20035163 20035164 20035255 20035256 20035452 20035453 20035454 20077208 20077209 20077210 20077211 20077248 20085800 20085801 20085802 20085803 20085804 20085805 20085806 20086310 20086311 20086312 20086313 20086314 20086315 20095355 20106470 20106471 20106472 20106473 20106474 20115306 20115307 20115308 20115309 20115310 20116459 20116460 20116506 20116842 20116843 20116959 20116960 20117003 20117004 20117005 20126275 20126276 20126277 20126278 21026315 21026316 21036130 21036131 21036132 21036133 21036134 21036135 21036136 20016252 20016253 20016254 20016255 20016256 20016257 20016258 20016259 20016260 20016261 20016540 20016541 20016542 20016543 20016544 20016689 20016690 20016691 20016692 20016693 20017011 20017012 20017013 20017014 20017015 20017073 20017074 20017075 20017076 20027157 20027158 20027159 20027160 20035250 20035251 20035685 20035686 20035687 20036089 20036090 20036091 20036092 20036184 20036185 20036186 20036434 20036458 20036459 20036460 20036461 20036462 20036463 20036464 20056672 20056698 20056699 20056700 20056701 20056702 20066601 20066602 20066603 20066604 20066605 20067001 20067002 20067003 20067004 20067005 20067006 20067007 20067008 20067218 20067219 20067220 20067221 20067222 20067223 20067224 20067225 20067226 20067227 20075225 20075226 20075228 20075229 20085419 20085420 20085510 20085511 20085512 20085768 20085769 20085829 20085830 20085831 20085832 20085833 20085834 20085835 20106574 20106575 20106576 20106577 20106578 20106579 20115320 20115321 20115322 20115351 20115323 20115324 20115329 20115335 20115336 20115345 20115346 20115330 20115331 20115332 20115333 20115337 20115338 20115339 20115325 20115326 20115327 20115334 20115340 20116509 20116510 20116511 20125315 20125316 20125458 20125459 20125460 20125461 20125523 20125524 20125525 20125582 20125583 21016029 21016030 21016031 21016032 21016033 21016034 21016035 21016036 21016037 21016038 21016233 21016234 21016235 21016236 21016310 21016311 21016312 21016313 21016314 21016315 21016316 21016317 21016428 21016429 21016430 21016431 21016432 21016598 21016599 21016600 21016601 21016656 21016657 21016658 21025037 21025038 21025039 21025040 21025041 21025042 21025043 21025512 21025513 21025514 21025515 21025516 21025517 21025518 21025519 21025520 21025521 21025522 21025523 21025524 21025525 21025747 21025748 21025749 21025750 21025751 21025752 21025753 21025754 21025755 21025756 21025757 21025758 21026234 21026235 21025759 21026189 21026190 21026191 21026192 21026236 21026237 21026238 21026239 21026240 21026241 21026242 21026243 21026244 21035339 2103535… (truncated, 6575 characters total — see the official FDA record for the full value)
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E

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: 21015553
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

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 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

Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable) 2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable) 2096513-001-S FLOW SENSOR ASSEMBLY 5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG 5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG

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:
Flow sensors with date of manufacture prior to 2021-06 etched on body of the flow sensor.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006

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:  20077170 20077171 20077319 20077320
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
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 SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006

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:  20025345 20025483 20037040 20037041 20037042 20086605 20086606 20086696 20095927 20096020 20105323 20125599 20125695 20125709 20125710 21015395
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSite Port (Burette) 2 SmartSite Y-Sites, REF: 11613191; BD Alaris Pump Infusion Buerette Set Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2440-0600; BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Site, REF: 2441-0007; BD Alaris Pump Infusion Buerette Set Low Sorbing Tubing Smartsite Port (Burette), REF: 2444-0007; BD Alaris Pump Infusion Buerette Set Ball Valve Smartsite Port (Burette) 2 Smartsite Y-Sites, REF: 2447-0007; BD Alaris Pump Infusion Set Back Check Valve 4-Way Stopcock 3 Smartsite Y-Sites Extension Set With SmartSite Port, REF: C24104E

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:  20055717 20066810 20066818 20066819 20077318 20077321 20077322 20077522 20077523 20077541 20086584 20106957 20106958 20106959 21025085 21025086 21025220 20025114 20025123 20026226 20026227 20026322 20026323 20026382 20026383 20026510 20056946 20056947 20057055 20057056 20017423 20096285 20096286 20015347 20016918 20016919 20016960 20016961 20017112 20035102 20035133 20035134 20035281 20035295 20035296 20035368 20035526 20035527 20035603 20035604 20056757 20065191 20065192 20065281 20065282 20065298 20065299 20065346 20065347 20065362 20065759 20065944 20065945 20065946 20075258 20075510 20075511 20075512 20075577 20075643 20075644 20075660 20075719 20075720 20075721 20075887 20075888 20075889 20075890 20076104 20076847 20076848 20076872 20076873 20076874 20076965 20076966 20076967 20076968 20076969 20077074 20077075 20085132 20085133 20085134 20085135 20085697 20085698 20085699 20085729 20085730 20085731 20085858 20085859 20085875 20085876 20086019 20086020 20086036 20086037 20086213 20086214 20086227 20086228 20086229 20086338 20086339 20086353 20086354 20086491 20086924 20086960 20086966 20086965 20087333 20087334 20087341 20087412 20096174 20096183 20096260 20096366 20096400 20096401 20097100 20097101 20097102 20097157 20015346 20056758 20056830 20056850 20056851 20066701 20066724 20066775 20066776 20066777 20105671 20105706 20125218 20125219 21025839 21025840 21025841 20017400 20017401 20036962
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 2, 2021

BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006

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:  20066405 20075901 20075902 20076376 20076377 20116469 21016457 21016458 21016459 21016460 21016690 21016691 21035305 21035306 21035418 21035419 21035420 21035421 21035422 21035423 21035424
Recalling firm:
CAREFUSION
View official FDA record (opens in a new tab)