BIGNOPE
Ko-fi

Recalls affecting South Dakota

Data last updated: September 9, 2026 at 1:18 PM UTC

16,341 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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

LipofitLipofit 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

KofinasGarlic 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)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey 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/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust 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

MartinaMangoes

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
Class IHigh risk
DrugChemicalUndeclaredRecalled June 18, 2020

A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Road Suite 1, Saginaw, MI 48603

Chemical contamination: product contains elevated levels of not listed on the label lead.

ALL 50 STATES
Full report

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

Recall #:
D-1454-2020
Lot/product code:
FG003106
Recalling firm:
MICHIGAN HERBAL REMEDIES
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 20, 2020

Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

ALL 50 STATES
Full report

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

Recall #:
85868
Lot/product code:
SN 300162, 300163, 300174, 300176
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 20, 2020

Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

ALL 50 STATES
Full report

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

Recall #:
85868
Lot/product code:
SN 353020, 353021, 353023
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 20, 2020

Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

ALL 50 STATES
Full report

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

Recall #:
85868
Lot/product code:
SN 600229, 600230, 600232, 600271, 600282
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2020

TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses

Colored contact lenses were distributed without FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
85923
Lot/product code:
Date of manufacture: 2018-08
Recalling firm:
Chengdu Ai Qin E-commerce Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2020

TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses

Colored contact lenses were distributed without FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
85923
Lot/product code:
Date of manufacture: 2018-08
Recalling firm:
Chengdu Ai Qin E-commerce Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2020

TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses

Colored contact lenses were distributed without FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
85923
Lot/product code:
Date of manufacture: 2018-08
Recalling firm:
Chengdu Ai Qin E-commerce Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2020

TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses

Colored contact lenses were distributed without FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
85923
Lot/product code:
Date of manufacture: 2018-08
Recalling firm:
Chengdu Ai Qin E-commerce Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2020

TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

Colored contact lenses were distributed without FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
85923
Lot/product code:
Date of manufacture: 2018-08
Recalling firm:
Chengdu Ai Qin E-commerce Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2020

TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses

Colored contact lenses were distributed without FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
85923
Lot/product code:
Date of manufacture: 2018-08
Recalling firm:
Chengdu Ai Qin E-commerce Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 23, 2020

TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses

Colored contact lenses were distributed without FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
85923
Lot/product code:
Date of manufacture: 2018-08
Recalling firm:
Chengdu Ai Qin E-commerce Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 24, 2020

Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

ALL 50 STATES
Full report

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

Recall #:
85984
Lot/product code:
Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2020

IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.

ALL 50 STATES
Full report

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

Recall #:
85795
Lot/product code:
Serial numbers: DE43804813 DE43804952 DE43804945 DE43806034 DE43806054 DE43803806 DE43803822 DE43803824 DE43803907 DE43803911 DE43803915 DE43803983 DE43803986 DE43803988 DE43803989 DE43806224 DE43803973 DE43803895 DE43804009 DE43803778 DE43803752 DE43803762 DE43803766 DE43803772 DE43803773 DE43803774 DE43803790 DE43805609 DE43804358 DE43804391 DE43805722 DE43804085 DE43804093 DE43803753 DE43803754 DE43803769 DE43803823 DE43803831 DE43803836 DE43803841 DE43805272 DE43805280 DE43805291 DE43805295 DE43803802 DE43803812 DE43803814 DE43803815 DE43803826 DE43803828 DE43805705 DE43805709 DE43805713 DE43805717 DE43805720 DE43805725 DE43805735 DE43805744 DE43805515 DE43805516 DE43805522 DE43805526 DE43805574 DE43805715 DE43805734 DE43804627 DE43804634 DE43804636 DE43804560 DE43804563 DE43804566 DE43804567 DE43804576 DE43804090 DE43804102 DE43804017 DE43804200 DE43804204 DE43804216 DE43804880 DE43804133 DE43804138 DE43805110 DE43805130 DE43806607 DE43806724 DE43804918 DE43804927 DE43806373 DE43806511 DE43806567 DE43806585 DE43805905 DE43805907 DE43806483 DE43806494 DE43806500 DE43806503 DE43806117 DE43806142 DE43806144 DE43805411 DE43804841 DE43805620 DE43805459 DE43803936 DE43806568 DE43804140 DE43804951 DE43805619 DE43804302 DE43805964 DE43805058 DE43805060 DE43805197 DE43805200 DE43805204 DE43805205 DE43805213 DE43806631 DE43805333 DE43805338 DE43805349 DE43805352 DE43805904 DE43805908 DE43805909 DE43805111 DE43805113 DE43805116 DE43805122 DE43805124 DE43805331 DE43805191 DE43803708 DE43803716 DE43803718 DE43803855 DE43806326 DE43806329 DE43806334 DE43806335 DE43806338 DE43806462 DE43806468 DE43805952 DE43803893 DE43803902 DE43803987 DE43806062 DE43806064 DE43806078 DE43806532 DE43806077 DE43806084 DE43806090 DE43805271 DE43806439 DE43806558 DE43806197 DE43806244 DE43804593 DE43805842 DE43805867 DE43805873 DE43805991 DE43805992 DE43805998 DE43806001 DE43806005 DE43806007 DE43806009 DE43806015 DE43806022 DE43804824 DE43803972 DE43803959 DE43803974 DE43803978 DE43804304 DE43804816 DE43804821 DE43804822 DE43804830 DE43804831 DE43804884 DE43804885 DE43804886 DE43804887 DE43804889 DE43804898 DE43804901 DE43804728 DE43804896 DE43804934 DE43804939 DE43804936 DE43804941 DE43804956 DE43804962 DE43804964 DE43804967 DE43804968 DE43805013 DE43804980 DE43804981 DE43805418 DE43805421 DE43805429 DE43805435 DE43805353 DE43805358 DE43805422 DE43805428 DE43805414 DE43805419 DE43805423 DE43805427 DE43805438 DE43805440 DE43805441 DE43805444 DE43805789 DE43805790 DE43805794 DE43805795 DE43805803 DE43805805 DE43805810 DE43805895 DE43805901 DE43805924 DE43805927 DE43805928 DE43805931 DE43805932 DE43805934 DE43805916 DE43805920 DE43805923 DE43805935 DE43805937 DE43805941 DE43805943 DE43806343 DE43806345 DE43806360 DE43806474 DE43806478 DE43806481 DE43806645 DE43806745 DE43806752 DE43806755 DE43804881 DE43806721 DE43803680 DE43804845 DE43805030 DE43804145 DE43805786 DE43805791 DE43805792 DE43805793 DE43805796 DE43805798 DE43805799 DE43805800 DE43805801 DE43805802 DE43804848 DE43805118 DE43804855 DE43804867 DE43804876 DE43804904 DE43804906 DE43804907 DE43804910 DE43804912 DE43804920 DE43804928 DE43805211 DE43805212 DE43804817 DE43806587 DE43805028 DE43804842 DE43804849 DE43805091 DE43803968 DE43804212 DE43804219 DE43805804 DE43805807 DE43805808 DE43805809 DE43805811 DE43805812 DE43805813 DE43805814 DE43805339 DE43805340 DE43805342 DE43805343 DE43805344 DE43805346 DE43805347 DE43805348 DE43805351 DE43805361 DE43805437 DE43805439 DE43805443 DE43805001 DE43805022 DE43805044 DE43803953 DE43803954 DE43803956 DE43803957 DE43803679 DE43805337 DE43805341 DE43805345 DE43805029 DE43804823 DE43806471 DE43806492 DE43806496 DE43806497 DE43806499 DE43806505 DE43806506 DE43806507 DE43806509 DE43804954 DE43804957 DE43804979 DE43804988 DE43804911 DE43805004 DE43805008 DE43805021 DE43805025 DE43805026 DE43803872 DE43805325 DE43805357 DE43805359 DE43804875 DE43804878 DE43804879 DE43805038 DE43805045 DE43805067 DE43805068 DE43805069 DE43805070 DE43805072 DE43805083 DE43804217 DE43804218 DE43805787 DE43804291 DE43804738 DE43804740 DE43804744 DE43806106 DE43806107 DE43806108 DE43806109 DE43806111 DE43806112 DE43806113 DE43806115 DE43806122 DE43806126 DE43806127 DE43806131 DE43806133 DE43806135 DE43806136 DE43806138 DE43806139 DE43806140 DE43804191 DE43804192 DE43804195 DE43804199 DE43804202 DE43804205 DE43804210 DE43804213 DE43804214 DE43803647 DE43803705 DE43803706 DE43803713 DE43803721 DE43804915 DE43804924 DE43804929 DE43804931 DE43803699 DE43805946 DE43806110 DE43806116 DE43806118 DE43806119 DE43806120 DE43806121 DE43806123 DE43806124 DE43806125 DE43806128 DE43806130 DE43806134 DE43806137 DE43806141 DE43806143 DE43806327 DE43806330 DE43806332 DE43806336 DE43806337 DE43806342 DE43806346 DE43806347 DE43806348 DE43806349 DE43806350 DE43805417 DE43806145 DE43803652 DE43803653 DE43803654 DE43803659 DE43803662 DE43803665 DE43803668 DE43803676 DE43803678 DE43804851 DE43804953 DE43804975 DE43804976 DE43804990 DE43804993 DE43804999 DE43805012 DE43803650 DE43805206 D… (truncated, 33837 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2020

Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

ALL 50 STATES
Full report

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

Recall #:
85912
Lot/product code:
Model Numbers: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2020

Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.

ALL 50 STATES
Full report

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

Recall #:
86001
Lot/product code:
Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, F2513452X
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2020

Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.

ALL 50 STATES
Full report

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

Recall #:
86001
Lot/product code:
Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2020

PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false alarm being thrown and in rare cases results in an incomplete move which will affect the current inhale/exhale cycle.

ALL 50 STATES
Full report

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

Recall #:
86082
Lot/product code:
Lot #: EV123732 Serial #s: L1002, L1005, L1006
Recalling firm:
Precision Valve & Automation,Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2020

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

ALL 50 STATES
Full report

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

Recall #:
85912
Lot/product code:
Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

There are reports of the suction catheter coming apart from the device assembly during use.

ALL 50 STATES
Full report

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

Recall #:
85983
Lot/product code:
Model: DYNCPTP14T, Lot #6918100021:
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

There are reports of the suction catheter coming apart from the device assembly during use.

ALL 50 STATES
Full report

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

Recall #:
85983
Lot/product code:
Model: DYNCPTP14, Lot #6919020016:
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)