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Recalls affecting Kansas

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

16,731 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)
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)
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)
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
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2020

RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

Full report

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

Recall #:
86317
Lot/product code:
Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, UDI: 00888912144599
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2020

RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044

Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

Full report

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

Recall #:
86317
Lot/product code:
Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 10, 2020

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

Failed Stability Specifications: not meeting quality requirements result for enzyme activity levels noted during routine stability testing.

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-1507-2020
Lot/product code:
Lot #: A9306, Exp 2/28/2022
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A019X T7K037X T8H021X T8L102X T9E097X T0A105X T7K038X T8H050X T8L103X T9E098X T0A117X T7K039X T8J044X T8M010X T9F025X T0A141X T7K040X T8J045X T9A037X T9F047X T0B132X T7K041X T8J060X T9A128X T9F048X T0C045X T7L040X T8K044X T9B002X T9F098X T0C102X T7L041X T8K045X T9B003X T9H112X T0C128X T8B042X T8K046X T9C065X T9H146X T0D057X T8B043X T8K052X T9C066X T9K003X T0D120X T8C032X T8K075X T9C111X T9L039X T7G002X T8C033X T8K076X T9C145X T9M029X T7H005X T8E059X T8K092X T9D140X T9M049X T7H008X T8E060X T8L033X T9E027X T9M050X T7K036X T8H020X T8L099X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A013X  T7L050X  T8E048X  T8K051X  T9F118X T0A051X  T7L051X  T8E055X  T8K093X  T9G028X T0A085X  T7L052X  T8E056X  T8L129X  T9G030X T0B025X  T7M021X  T8E061X  T8L130X  T9G038X T0B032X  T7M022X  T8E062X  T8M009X  T9G088X T0B046X  T8A001X  T8E067X  T8M011X  T9G089X T0B047X  T8A002X  T8E068X  T8M097X  T9G090X T0B056X  T8A003X  T8F001X  T9A009X  T9G094X T0B073X  T8A004X  T8F002X  T9A031X  T9G159X T0B081X  T8A045X  T8F026X  T9A056X  T9G160X T0C043X  T8A046X  T8F045X  T9A099X  T9H042X T0C068X  T8A060X  T8F046X  T9B001X  T9H100X T0C069X  T8A061X  T8F047X  T9B004X  T9H101X T0C070X  T8B003X  T8F077X  T9B005X  T9H113X T0C103X  T8B037X  T8H001X  T9B038X  T9H114X T0D054X  T8B038X  T8H002X  T9C007X  T9J030X T0D059X  T8B039X  T8H003X  T9C008X  T9J035X T0D061X  T8B040X  T8H005X  T9C069X  T9J048X T0D115X  T8B041X  T8H006X  T9C070X  T9J073X T0E050X  T8C012X  T8H019X  T9C071X  T9J096X T7F019X  T8C034X  T8H051X  T9C156X  T9J097X T7F021X  T8C035X  T8H052X  T9E030X  T9J098X T7F022X  T8C041X  T8H072X  T9E069X  T9K002X T7J003X  T8C042X  T8J027X  T9E070X  T9K068X T7J004X  T8C044X  T8J038X  T9E071X  T9K104X T7J005X  T8D011X  T8J041X  T9E072X  T9K105X T7J013X  T8D057X  T8J042X  T9E111X  T9L019X T7J020X  T8D058X  T8J058X  T9E119X  T9L074X T7J032X  T8D059X  T8J067X  T9E120X  T9L075X T7L028X  T8D060X  T8K007X  T9F026X  T9L102X T7L029X  T8D061X  T8K009X  T9F049X  T9L103X T7L030X  T8D062X  T8K043X  T9F050X  T9M109X T7L048X  T8E047X  T8K050X  T9F078X  T9M110X T7L049X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A016X T8D009X T8E058X T8H024X T9D052X T0B130X T8D010X T8E069X T8H025X T9D149X T0D070X T8D012X T8H004X T8H061X T9E081X T7H001X T8D013X T8H008X T8M044X T9E082X T7L024X T8D041X T8H009X T9A032X T9F133X T7L025X T8D042X T8H010X T9A033X T9G029X T8B012X T8D043X T8H011X T9A082X T9G037X T8B013X T8D044X T8H012X T9B039X T9G085X T8C026X T8D045X T8H013X T9B040X T9G086X T8C027X T8D046X T8H014X T9D043X T9G093X T8C045X T8E049X T8H022X T9D050X T9K069X T8C046X T8E050X T8H023X T9D051X T9M069X T8C047X T8E057X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  00Z2117
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A018X T8B045X T8E051X T8L052X T9E050X T0A106X T8B046X T8E052X T8L101X T9F024X T0B131X T8B047X T8E065X T8L131X T9F037X T0D138X T8C025X T8E066X T8L132X T9F040X T0E011X T8C030X T8H015X T8L143X T9F044X T7G001X T8C031X T8H016X T8M080X T9F045X T7H004X T8C043X T8H017X T8M092X T9F046X T7H007X T8D001X T8H018X T8M093X T9F097X T7J025X T8D002X T8H049X T8M094X T9G031X T7K018X T8D003X T8J012X T9A006X T9G124X T7K034X T8D004X T8J026X T9A034X T9G125X T7L022X T8D005X T8J039X T9A035X T9H041X T7L036X T8D006X T8J040X T9A118X T9H102X T7L037X T8D014X T8K006X T9B060X T9H110X T8A058X T8D015X T8K008X T9C023X T9J071X T8A059X T8D047X T8L012X T9C024X T9J114X T8A062X T8D048X T8L013X T9C058X T9K077X T8A063X T8D049X T8L014X T9C059X T9L021X T8A064X T8D050X T8L015X T9D053X T9L037X T8A065X T8D051X T8L016X T9D099X T9M017X T8B001X T8D052X T8L049X T9D124X T9M018X T8B002X T8D053X T8L050X T9D125X T9C060X T8B044X T8D054X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A104X T7L042X T8D056X T8L032X T9D044X T0C041X T7L043X T8E053X T8L051X T9D047X T0C042X T7L044X T8E054X T8L104X T9D048X T7F018X T7L045X T8F041X T8L105X T9D049X T7F023X T7L046X T8F042X T8M045X T9D055X T7F024X T7L047X T8F043X T9A007X T9E025X T7J006X T8A005X T8F075X T9A008X T9F051X T7J011X T8A006X T8J011X T9B041X T9H144X T7J012X T8A041X T8K063X T9B042X T9J034X T7K030X T8A042X T8L028X T9C067X T9K078X T7K031X T8C039X T8L029X T9C068X T9K079X T7K032X T8C040X T8L030X T9C146X T9L020X T7K033X T8D055X T8L031X T9C157X T9L034X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X  T8M079X T7G003X T8D007X T8K047X T9F132X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2020

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

ALL 50 STATES
Full report

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

Recall #:
86214
Lot/product code:
Lot Numbers:  T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 17, 2020

Speed Stitch Needle Cassette

Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

Full report

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

Recall #:
86290
Lot/product code:
Model: OM-8850 Lot Numbers: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239 & 2032526
Recalling firm:
ArthroCare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2020

Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.

ALL 50 STATES
Full report

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

Recall #:
85258
Lot/product code:
All Serial Numbers
Recalling firm:
Imactis
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2020

Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site

The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).

ALL 50 STATES
Full report

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

Recall #:
86173
Lot/product code:
Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C  Model # 720-005-001 (BPSI SET 8 VENT PROBE); Lot Numbers:  I8881-D I8873-D I9057-D I9058-D I9209-D I9213-D I9227-D I9235-D I9236-D I9237-D I9278-D I9280-D I9282-D I9283-D I9299-D I9309-D I9322-D I9324-D I9356-D I9358-D I9360-D I9361-D I9362-D I9363-D I9364-D I9365-D
Recalling firm:
Genicon, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001

Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

ALL 50 STATES
Full report

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

Recall #:
86399
Lot/product code:
All units
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

ALL 50 STATES
Full report

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

Recall #:
86399
Lot/product code:
All units
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3762; 35" (89 cm) Appx 6.6 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Low Protein Binding Filter, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3763

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots: 4605964, 4764534, 4903199, 4901115, 4849120, 4865839, 4895024, 4603209, 4866030
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Spiros, REF: CH3367; 7" (18 cm) Appx 0.40 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, Spiros, 2 Clamps, REF: CH3379; 16" (41 cm) Appx 4.4 ml, Ext Set w/MicroClave, 0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3381; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Drop-in Red Cap, 2 Hanger, REF: CH3386; 40" (102 cm) Appx 7.3 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: CH3401; 60" (152 cm) Appx 0.62 ml, Smallbore Ext Set w/MicroClave, Clamp, Spiros w/Red Cap, REF: CH3405; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, REF: CH3453; 73" (185 cm) Appx 2.1 ml, Smallbore Ext Set w/MicroClave Clear, Spiros, Clamp, REF: CH3485; 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros w/Red Cap, Bag Hanger, Drop-In Priming Cap, REF: CH3517; 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/MicroClave Clear, 2 Spiros, 3 Clamps, Priming Cap, REF: CH3523; 74" (188 cm) Smallbore Ext Set w/MicroClave, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3533; 74 IN (188 cm) Appx 0.92 ml, Smallbore Set, MicroClave, 1.2 Micron Fil, Spiros, Red Cap, REF: CH3538; 18" (46 cm) Appx 5.1 ml, Ext Set w/0.2 Micron Filter, Clave, Spiros, Clamp, REF: CH3556; 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; 4-Way Clave Stopcock w/2 Spiros, REF: B4194; Spiros, Closed Male Connector w/Red Cap (10 Units), REF: Z7093; 47" (119 cm) 150 ml Burette Set w/MicroClave, 20 Drop In-Line Drip Chamber w/Ball Shut Off, Spiros, REF: Z7182

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lot:  4764635, 4887770, 4787215, 4877053, 4737148, 4850390, 4749863, 4849350, 4867377, 4741238, 4763286, 4774081, 4809085, 4877072, 4908343, 4719787, 4734320, 4741243, 4749867, 4854763, 4895575, 4849358, 4751063, 4763289, 4775529, 4724813, 4749880, 4854774, 4734335, 4757706, 4849376, 4764061, 4793547, 4749900, 4756873, 4777159, 4799805, 4902253, 4751908, 4793550, 4849389, 4896178, 4733498, 4764065, 4849391, 4719565, 4751101, 4790766, 4774117, 4736129, 4895706, 4858370
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots: 4758192, 4763891, 4794293, 4807842, 4849283, 4866670, 4877784, 4902534, 4909635                                                     ,
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots: 4727479, 4784305
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: 011-CH3266; 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Purple Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: 011-CH3446; 61 cm (24") Appx 8.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros w/Purple Cap, 3 Clamps (1 Blue, 2 White), Check Valve, Dry Spike Adapter, REF: 011-CH3729; 25 UNITS of Spiros CLOSED MALE LUER, REF: 011-H2457; Appx 1.0 ml, Adattatore per Pompa con Spiros, REF: 011-H2629; 179 cm (70") Appx 11.5 ml, PUR Ambr. Deflussore con Spiros, Camera, BCV, Y-Clave e LL Gir., REF: 011-H2776; 180 cm (71IN)APPX 11.5ml,PUR AMBR,Spiros,CAMERA,REG.FLUSSO,BCV,Y-Clave, REF: 011-H2864-HSR; 181cm(71 IN)APPX11.6ml,PUR DEFLUSSORE,Spiros,20 DROP IN LINE,BCV,Clave, REF: 011-H2904; 38 cm (15 IN) APPX 2.9 ml, TRIFUSE EXT SET, 3 MicroClave, Spiros, PURPLE CAP, REF: 011-H3449; 42cm(16.5 IN)APPX 2.6ml,PUR TRANSFER SET,Clave ADDITIVE PORT,BCV,Spiros, REF: 011-H3597; 41cm(16 IN)APPX 2.9ml,PUR SET PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3628; 41cm(16 IN)APPX 3.1ml,SET AMBRATO,PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3629; 42cm(16.5 IN)APPX 5.6ml,SET,PERFORATORE,Clave,FILTRO,VALVOLA,Spiros, REF: 011-H3630; 109 cm(43 IN) APPX 7.2 ml,KIT,EXT SET W/Spiros,STOPCOCK,5 Clave,4-GANG STOPCOCK, REF: 011-MC330632; 2 Ext Sets w/5-Gang Stopcock, 9 Clave, Spiros, Stopcock, REF: 011-MC33242; Kit for multiple transfers, REF: 011-N1000; Kit per il riempimento pompe elastomeriche con SPIROS / Kit for elastomeric pump priming with SPIROS, REF: 011-N1000-P2; APPX 2.3ml, ZYTO-VERBINDUNGSLEITUNG (ZYTO-CONNECTING LINE), REF: 011-N1664SP; Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros, REF: 034-H2629; Spinning Spiros Closed Male Luer, Red Cap (No Flange), REF: CH2000S-NR; 15" (38 cm) Appx 5.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros, 3 Clamps (Blue, 2 White), Dry Spike Adapter, REF: CH3187; 14" (36 cm) Appx 8.0 ml, Quinfuse Add-On Set w/4 Spiros, Bag Spike, 5 Clamps (Blue, 4 Red), Dry Spike Adapter, REF: CH3225; 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros, Bag Spike, 4 Clamps (Blue, 3 Red), Dry Spike Adapter, REF: CH3226; 16" (41 cm) Appx 6.3 ml, Trifuse Add-On Set w/2 Spiros, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: CH3227; 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros, REF: CH3235; 28" (71 cm) Appx 5.1 ml, Add On Set w/Clave Spike, Spiros, Clamp, REF: CH3354; 16cm(6 IN)APPX 2.4ml,SET,MicroClave Clear,STOPCOCK,DROP-IN ADD-ON,Spiros, REF CH3411: APPX 1.9 ml,13 cm (5 IN),BAG SPIKE,Spiros,ACCESS DEVICE w/Clave, REF: CH3502; 60 (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; Spinning Spiros Closed Male Luer, REF: K7040-001; APPX 0.76ml, 4-WAY STOPCOCK w/2 Clave, VIAL ADAPTER, 3 Spiros, REF: K7052-001; ZYTOmed Verab.-Set Onko II lichtschutz, REF: SN1205AG; ZYTOmed - Verabreichungs-Set Onko III lichtgeschtzt, REF: SN1206A; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots: 4630846, 4848415, 4734764, 4734940, 4752044, 4742983, 4764957, 4878172, 4808952, 4867502, 4804800, 4854732, 4783273, 4773067, 4807223, 4800168, 4877026, 4752842, 4773432, 4764194, 4727034, 4847780, 4876626, 4548846, 4573171, 4867154, 4515064, 4574113, 4743010, 4773247, 4848995, 4740817, 4774162, 4877106, 4902461, 4711498, 4719930, 4740835, 4798726, 4866446, 4894490, 4727444, 4741918, 4778013, 4800251, 4806881, 4743840, 4734281, 4775528, 4799761, 4763261, 4774080, 4790739, 4749875, 4794599, 4802672, 4859281, 4718351, 4727042, 4741435, 4774258, 4866217, 4875126, 4899256, 4774269, 4777289, 4849437, 4853031, 4847272, 4882644                                       ,
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe w/Spinning Spiros, Red Cap, REF: CH2060; 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CH3011; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Red Cap, Hanger, REF: CH3011-C; 40 IN (102 cm) App 4.8 ml, Admin Set, 20 Drop, 2 Spiros, Bag Hanger, REF: CH3020; 14 IN (36 cm) App 4.8 ml, Bifuse Add-On Set, Spiros w/Red Cap, Bag Spike, REF: CH3033; 5" (13 cm) Bag Spike Adapter w/Spiros w/Red Cap, Vented Cap, REF: CH3034; 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Hanger, REF: CH3128; Oncology Kit w/60" (152 cm) Appx 2.3 ml, Smallbore Ext Set w/Spiros, Anti-Siphon Valve, ChemoClave, Clamp, Rotating Luer, Double ChemoClave Syringe Transfer Set, Spiros w/Red Cap, REF: CH3606; 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps, REF: CH3625; 86" (218 cm) Appx 10.4 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, REF: CH3642; Oncology Kit w/40" (102 cm) Appx 4.7 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, Double ChemoClave Syringe Transfer Set, REF: CH3677; 5.5" (14 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 ChemoClave, Spiros w/Red Cap, 3 Clamps, REF: CH3700; 50 IN (127 cm) Appx 6.4 ml, Ext Set w/ChemoClave, Spiros w/Red Cap, Clamp, REF: CH3703; 16 IN (41 cm) Appx 1.6 ml, Ext Set, ChemoClave, Spiros w/Red Cap, REF: CH3715; Oncology Kit, Ext w/Spiros, Grad Conn, 2 Vial Spikes w/Clave, Spinning Spiros , REF: CH3929; Oncology Kit, w/Ext, MicroClave, Clave, Grad Conn, Transfer, Spiros, Vial Spike, Clave, REF: CH3932; Oncology Kit, 12 IN Ext, Spiros, Graduated Adapter, 2 ChemoClave w/Vial Spike, Spiros, REF: CH3943; Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter, ChemoClave Vented Vial Spike, 20mm, ChemoClave Vented Vial Spike, 13mm, REF: CH3944; Oncology Kit, 16 IN (41 cm) Ext Set, ChemoClave, Graduated Conn, 2 ChemoClave w/Vial Spike, Spiros, REF: CH3946; Oncology Kit, 21" (53 cm) Appx 3.2 ml, Ext Set w/Spiros w/Red Cap, Graduated Adapter, Locking Universal Vented Vial Spike w/ChemoClave, Closed Vial Spike, 13mm w/ChemoClave, Spinning Spiros w/Red Cap, REF: CH3949; 46" (117 cm) 50 ml, Diluent Set for Channel 2 w/20 Drop Drip Chamber, Spiros, REF: CH4002

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots:  4553702, 4605473, 4763191, 4775520, 4849205, 4549847, 4548779, 4572314, 4734247, 4763917, 4849208, 4741169, 4763921, 4560231, 4750962, 4549850, 4763200, 4734249, 4794307, 4806855, 4849220, 4861176, 4877472, 4605484, 4749780, 4795448, 4876942, 4719395, 4737146, 4764825, 4800210, 4866411, 4800214, 4734262, 4794308, 4795454, 4806862, 4849239, 4849248, 4849251, 4605504, 4719410, 4734273, 4757665, 4763982, 4799740, 4861174, 4605074, 4741282, 4751117, 4809117, 4877145, 4894538, 4557534, 4733509, 4741291, 4743763, 4774120, 4733512, 4865834, 4894550, 4573105, 4803126, 4808046, 4860027, 4806400, 4720476, 4724725, 4749443, 4786358, 4802674, 4849131, 4783296, 4730109, 4742662, 4759699, 4768019, 4794497, 4877852, 4897107, 4712378, 4749445, 4799839, 4806855, 4861176, 4719395, 4800210, 4764826, 4800214, 4719927, 4726732, 4733428, 4734262, 4741183, 4756802, 4763958, 4794308, 4794310, 4795452, 4806862, 4849230, 4849233, 4849239, 4719410, 4799839, 4859282
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3020; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, Drop-In Red Cap, REF: CL3028; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3028T; 42" (107 cm) Appx 5.2 ml, Admin Set w/20 Drop In-Line Chamber, ChemoLock w/Red Cap, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3361; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock; Spinning Spiros w/Red Cap, REF: CL3538; Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros; ChemoLock; ChemoLock Universal Vented Vial Spike; Bag Hanger, REF CL3929; 8.5" (22 cm) Appx 1.0 ml, Ext Set w/MicroClave Clear, ChemoLock Port, Spiros w/Red Cap, Clamp, REF: CL3931; 7.5" (19 cm) Appx 1.1 ml, Bifuse Ext Set w/ChemoLock Port, ChemoClave, Spiros, 2 Clamps, REF: CL3932; 30 IN(76cm)APPX 2.1ml, EXT SET w/ChemoLock w/RED CAP, Spiros RED CAP, REF: CL3935; Oncology Kit w/ChemoLock w/ChemoClave; Spinning Spiros w/ Red Cap, REF: CL3941; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock w/Red Cap, Vented Cap; ChemoLock Port w/Bag Spike; Spiros w/Red Cap, REF: CL3946; Oncology Kit, ChemoLock Bag Spike w/Additive Port, Vented Cap, Spiros, REF: CL3948; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960T; 60" (152 cm) Appx 7.4 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL4100; 30" (76 cm) Appx 3.6 ml, Admin Set w/20 Drop In-Line Drip Chamber, ChemoLock Additive Port, Spiros w/Red Cap, REF: CL4131; 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer, REF: CL4151; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros w/Red Cap, Drop-In ChemoLock Injector, Bag Hanger, REF: CL3978

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots:  4720479, 4724743, 4735699, 4775051, 4803047, 4808098, 4868079, 4868080, 4735696, 4763384, 4800367, 4866943, 4908482, 4724700, 4742639, 4758414, 4775030, 4787228, 4808060, 4848204, 4712385, 4724701, 4605106, 4733557, 4757782, 4775514, 4800370, 4724728, 4765922, 4867983, 4724703, 4749489, 4803140, 4878873, 4742641, 4758385, 4794501, 4720364, 4752843, 4799894, 4850394, 4866135, 4790865, 4735669, 4742630, 4758441, 4764898, 4787232, 4848213, 4867995, 4743901, 4765927, 4775070, 4777973, 4794503, 4606697, 4735662, 4803124, 4808069, 4867961, 4897098, 4898098, 4899830, 4573189, 4606684, 4749454, 4756268, 4803136, 4808059, 4848185, 4878880, 4726940, 4742091, 4738028, 4749474, 4560357, 4735675, 4714539, 4763384, 4800367, 4866943, 4908482, 4742641
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2020

5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave, Bag Hanger, REF: CH3240; 18 IN (46 cm) Appx 2.9 ml, Add-On Set w/Spiros, Clave Spike, Clamp, Cap, REF: CH3290; 27" (69 cm) Appx 5.2 ml, Bifuse Add-On Set w/15 Drop Drip Chamber, Spiros w/Red Cap, Check Valve, Vented Cap, Bag Hanger, REF: CH3294; Secondary IV Oncology Kit, REF: CH3322; 30 IN (76 cm) Appx 1.8 ml) Ext Set w/2 Spiros, 2 Red Caps, Clamp, REF: CH3327; 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers, REF: CH3373; Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port, REF: CH3397; 45" (114 cm) Appx 5.8 ml, Ext Set w/MicroClave, 2 Clave, Spiros w/Red Cap, 2 Clamps, REF: CH3403; Oncology Kit w/20" (51 cm) Ext Set w/MicroClave, Graduated Connector, Transfer Set w/Clave Additive Port, Spiros, Red Cap, 13mm Vial Spike w/Clave, REF: CH3507; Oncology Kit w/Clave Universal Vented Vial Spike, Spinning Spiros w/Red Cap, REF: CH3546; 22" (56 cm) Add-On 150 ml Burette Set (MicroClave, No Shut-Off), w/Spiros, 2 Clamps, Vented Cap, REF: CH3554; 4.5 IN (11 cm) Appx 0.43 ml, Ext Set, Spiros w/Red Cap, REF: CH3559; Oncology Kit w/Spinning Spiros, C-Clip, Red Cap, REF: CH3581; 5 IN (13 cm) Appx 0.57 ml, Ext Set, Anti-Siphon Valve, Spiros, REF: CH3582; Oncology Kit w/Spinning Spiros w/Red Cap, C-Clip; Priming Cap, REF: CH3589; 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: CH3639; 22" (56 cm) Appx 5.6ml, Ext Set, Trifuse w/4 Clave Clear, Spiros w/Red Cap, 1.2 Micron Filter, 4 Clamps, REF: CH3770; 6.5 IN (17 cm) Appx 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap, REF: CH3771; 47" (119 cm) 50 ml Diluent Set for Channel 2 w/20 Drop In-Line Drip Chamber, 2 Spiros, REF: CH4001; 47" (119 cm) 50 ml Diluent Set For Channel 2 w/Bag Spike w/MicroClave Additive Port, Spiros, REF: CH4009; 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: Z7100; 30" (76 cm) 50 ml Diluent Set for Channel 2 w/Spiros, REF: CH4006; 60 IN(152cm)APPX 0.45ml,SMALLBORE EXT,MicroCLAVE,Spiros, REF: Z7040; 6" (15 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 MicroClave, 3 Clamps, Spiros, REF: Z7151

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

ALL 50 STATES
Full report

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

Recall #:
86426
Lot/product code:
Lots:  4726847 4764618 4749803 4882578 4719415 4858408 4763254 4799746 4909239 4763263 4807851 4849307 4711357 4734298 4784307 4877040 4603746 4751052 4809068 4719780 4887803 4902877 4741245 4773197 4793534 4853586 4603189 4749895 4800302 4749463 4751098 4775532 4853625 4877133 4902884 4726180 4751919 4763325 4742008 4763328 4877406 4902270 4589996 4741273 4751930 4764078 4849398 4894536 4742017 4784331 4894544 4774127 4719576 4787217 4908406 4752847 4866868 4908415 4854840 4853711 4894570 4759148 4605923 4784875 4800246 4807647 4866700 4590960 4802679 4889077
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)