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Recalls affecting Kansas

Data last updated: September 10, 2026 at 1:16 PM UTC

16,731 recalls found
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Just announced

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

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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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 March 16, 2021

REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

ALL 50 STATES
▸Full report

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

Recall #:
87703
Lot/product code:
REF: 20124-01  UDI: (01) 1 0887709 07925 7 (17) 260101 (30) 50 (10) 5125197  Lot Number: 5142971
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

ALL 50 STATES
▸Full report

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

Recall #:
87703
Lot/product code:
REF: 034-H2629  UDI: (01) 1 0840619 07938 0 (17) 260101 (30) 50 (10) 5125301  Lot Number: 5125301
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

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▸Full report

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

Recall #:
87787
Lot/product code:
NDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

REF CL4151 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 - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

ALL 50 STATES
▸Full report

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

Recall #:
87703
Lot/product code:
REF: CL4151  UDI: (01) 1 0887709 09838 8 (17) 260101 (30) 50 (10) 5142912  Lot Number: 5142912
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

ALL 50 STATES
▸Full report

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

Recall #:
87703
Lot/product code:
REF: CL3011  UDI: (01) 1 0887709 05701 9 (17) 260101 (30) 50 (10) 5125298  Lot Number: 5125298
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

ALL 50 STATES
▸Full report

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

Recall #:
87787
Lot/product code:
NDC/UPC: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033

Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

ALL 50 STATES
▸Full report

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

Recall #:
87787
Lot/product code:
NDC/UPC: 456074613 All lots numbers shipped from 2/23/201 to 3/10/2021
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

ALL 50 STATES
▸Full report

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

Recall #:
87703
Lot/product code:
REF: CL3028T  UDI: (01) 1 0887709 09996 5 (17) 260101 (30) 50 (10) 5125199  Lot Number: 5125199
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled March 17, 2021

Real Alkalized Water, concentrate. 4 oz. glass bottle . Drinkrealwater.com

FDA was notified of cases of acute liver failure after consumption of Real Water

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

Recall #:
F-0482-2021
Lot/product code:
All codes
Recalling firm:
Real Water, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled March 17, 2021

Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon plastic bottles. Drinkrealwater.com

FDA was notified of cases of acute liver failure after consumption of Real Water

ALL 50 STATES
▸Full report

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

Recall #:
F-0481-2021
Lot/product code:
Real Water 16.9 oz., UPC (Case): 6-69149-10551-1, UPC (Single): 6-69149-10550-4 Real Water 1 Liter, UPC (Case): 6-69149-10553-5, UPC (Single): 6-69149-10552-8 Real Water 1.5 Ltr, UPC (Case): 6-69149-10555-9, UPC (Single): 6-69149-10554-2 Real Water 1 Gallon, UPC (Case): 6-69149-10561-0, UPC (Single): 6-69149-10560-3 ALL CODES of all products.
Recalling firm:
Real Water, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 18, 2021

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

The firm discovered through customer complaints that device segments may not meet specifications.

ALGAILINKSNJNYTX
▸Full report

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

Recall #:
92500
Lot/product code:
Item No. 15/2973/06; UDI-DI: 04026575340736.
Recalling firm:
Waldemar Link GmbH & Co. KG (Mfg Site)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 18, 2021

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left

The firm discovered through customer complaints that device segments may not meet specifications.

ALGAILINKSNJNYTX
▸Full report

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

Recall #:
92500
Lot/product code:
Item No. 15-2979/02; UDI-DI: 04026575328109.
Recalling firm:
Waldemar Link GmbH & Co. KG (Mfg Site)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 18, 2021

Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741

The incorrect dental pins were packaged and subsequently distributed.

ALL 50 STATES
▸Full report

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

Recall #:
87645
Lot/product code:
Lot/Batch number: K39841
Recalling firm:
Coltene Whaledent Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 18, 2021

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right

The firm discovered through customer complaints that device segments may not meet specifications.

ALGAILINKSNJNYTX
▸Full report

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

Recall #:
92500
Lot/product code:
Item No. 15-2973/05; UDI-DI: 04026575340699.
Recalling firm:
Waldemar Link GmbH & Co. KG (Mfg Site)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceBacteria/virusSalmonellaShigellaVibrioRecalled March 18, 2021

VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

ALL 50 STATES
▸Full report

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

Recall #:
87591
Lot/product code:
VERIGENE Processor SP: Model Number 10-0000-07, UDI 00840487101483; Serial Numbers 19072007, 18255013, 18255002, 18159005, 18159001, 17215007, 21060901, 21055901, 20310901, 18023004, 18023003, 18023002, 18023001, 19072015, 19072014, 18318010, 20261007, 20261004, 20261002, 20167003, 20153009, 20133001, 18344012, 18299005, 18299001, 18250014, 13210273, 13105142, 18235013, 18235010, 18214004, 13186249, 18214011, 17215006, 17188008, 17188007, 17188006, 17188005, 17188004, 17188003, 17188002, 17188001, 17130057, 17130055, 17130054, 17117041, 14196165, 18177009, 18177007, 21039901, 19192005, 14052037, 14142120, 14142119, 19295006, 19044007, 17262004, 14322266, 20094003, 19023004, 19023003, 19023002, 19023001, 16334080, 14218188, 14218187, 20188009, 20188007, 13133183, 19325007, 19325003, 19317010, 19233009, 17096038, 17096036, 18120006, 15208083, 15131078, 15096068, 14062046, 12324410, 12324409, 19260010, 19260005, 13018026, 13018025, 12236277, 18079009, 15096067, 16355087, 16347081, 15131075, 15131073, 14069059, 14069058, 14237219, 14237217, 16077012, 16077011, 20167006, 20167001, 20121009, 19140004, 17234005, 17234004, 14191156, 12305380, 12305379, 12303378, 12303377, 12303376, 12303375, 11213075, 11213073, 11213072, 11213071, 12236271, 12236270, 18128008, 12170169, 12170168, 19057001, 12038011, 15075059, 15075058, 20212006, 18172014, 19260006, 19192007, 20007010, 18318001, 12285355, 12285354, 17278007, 14322268, 20086010, 20086006, 12278340, 17096034, 15040037, 15040036, 17307006, 17307004, 18255007, 18255001, 13238308, 12107091, 20094005, 20036009, 18060001, 13087118, 13087117, 18333002, 18318008, 18226015, 20086009, 20086002, 19095007, 18333012, 17048020, 17048019, 13263328, 13263327, 19095014, 19084008, 17048011, 17017010, 14265244, 14265243, 14265242, 18250001, 18172007, 18172003, 18159002, 20133006, 20133004, 19031006, 19031005, 18344009, 12205218, 12205217, 12205216, 19140010, 19140007, 18214013, 20027004, 20212002, 20212001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 18079001, 18022005, 17157061, 18054003, 18054002, 12261312, 12261311, 12261310, 12261309, 12254304, 18128002, 15327108, 15327107, 18128006, 18120004, 18120001, 18099009, 18099007, 11276125, 11276124, 11276123, 11276122, 11186063, 11186062, 11152041, 14251232, 20111002, 20086008, 18177014, 18177006, 9202053, 18288014, 18288011, 18255004, 18250010, 18172008, 17017003, 13161218, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, D908, D09336158, D09336157, D09325136, D09325135, D09320135, D09320134, D09320133, D09320132, D09320131, D09320130, D09320129, D09320128, D09313126, D09255073, D09135024, D0912, D0909, D0908, D0903, 21025901, 20048006, 19233003, 19095013, 19095001, 19072011, 19072009, 19044003, 18344004, 18318009, 18299012, 18299008, 18288008, 18235007, 18235005, 18150009, 18088005, 18088003, 18072005, 18060009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039004, 18037005, 18037004, 18037003, 18037002, 18026002, 17356002, 17347002, 17340004, 17278001, 17242007, 17215001, 17117044, 17096037, 17096035, 17096033, 17096032, 17062026, 16347083, 16299066, 15327109, 15208088, 15131080, 15131079, 15075056, 15033030, 15033029, 15033026, 15020016, 15020015, 14307259, 14265248, 14265247, 14230210, 14230209, 14230201, 14211173, 14211172, 14142111, 14139104, 14043026, 14006008, 13315360, 13315352, 13301349, 13301348, 13301343, 13301342, 13238309, 13227296, 13224285, 13193257, 13186241, 13170229, 13140195, 13140194, 13133184, 13133181, 13127179, 13066087, 13060074, 13051065, 13051062, 13037048, 13008016, 13008009, 13008008, 13003013, 13003012, 13003011, 13003009, 12324413, 12317405, 12310394, 12310392, 12310391, 12303373, 12303372, 12303371, 12303370, 12285357, 12248292, 12248291, 12233259, 12205214, 12205213, 12205211, 12175193, 12175192, 12156162, 12145150, 12145148, 12145147, 12145146, 12145145, 12142138, 12088816, 12086077, 12069058, 12038815, 12038016, 12038015, 12016002, 11339160, 11339159, 11339158, 11339157, 11306147, 11306146, 11306144, 11306142, 11306141, 11236093, 11236092, 11236091, 11236090, 11236087, 11213085, 11213076, 11213074, 11186066, 11186064, 11152047, 11152046, 11152044, 11101028, 11021003, 10295149, 10295148, 10295147, 10295146, 10295145, 10295144, 10295143, 10295142, 10295141, 10295140, 10295139, 10295136, 10295135, 10278163, 10278133, 10278132, 10278131, 10278128, 10276131, 10250119, 10250118, 10250117, 10210115, 10210111, 10210110, 10210109, 10210108, 10210107, 10210106, 10210105, 10182104, 10182103, 10182102, 10182101, 10162085, 10139084, 10110058, 10099033, 10099032, 10035106, 10035105, 10035017R, 10014012, 10014003, 10014001, 09350165, 09350164, 09350163, 09350161, 09350160, 09350159, 09336158, 09336157, 09336150, 09336149, 09336147, 09336146, 09336145, 09336144, 09325138, 09320127, 09313120, 09313119, 09298118, 09298117, 09298116, 09293111, 09293109… (truncated, 12262 characters total — see the official FDA record for the full value)
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 18, 2021

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right

The firm discovered through customer complaints that device segments may not meet specifications.

ALGAILINKSNJNYTX
▸Full report

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

Recall #:
92500
Lot/product code:
Item No. 15-2979/01; UDI-DI: 04026575328093.
Recalling firm:
Waldemar Link GmbH & Co. KG (Mfg Site)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2021

Revolution CT

GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

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▸Full report

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

Recall #:
88150
Lot/product code:
5590000 5590000-6 5590000-2
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 19, 2021

Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

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▸Full report

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

Recall #:
87621
Lot/product code:
Lot: RD20/253/16, RD21/043/01, RD21/043/02
Recalling firm:
Cytocell Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 22, 2021

Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).

ALL 50 STATES
▸Full report

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

Recall #:
87482
Lot/product code:
All Systems. UDI: 10607567112312 10607567108407 10607567113449
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 22, 2021

Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).

ALL 50 STATES
▸Full report

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

Recall #:
87482
Lot/product code:
All Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 23, 2021

VenaSeal Closure System

Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

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

Recall #:
87619
Lot/product code:
Model Number SP-101: GTIN 20643169986279, Serial Numbers: 54143, 54145, 54146, 54147, 54148, 54149, 54150, 54151, 54152, 54396, 54397, 54398, 54399, 54417, 54418, 54419, 54420, 54618, 54619, 54620, 54621, 54622, 54771, 54772, 54773, 54774, 54775, 54776, 54794, 54795, 54796, 54924, 54925, 54926, 54927, 54928, 54929, 55027, 55028, 55029, 55030, 55031, 55032, 55068, 55069, 55070, 55071, 55072, 55073, 55113, 55114, 55115, 55116, 55437, 55438, 55439, 55440, 55441, 55442, 55483, 55484, 55485, 55486, 55487, 55488, 55594, 55595, 55596, 55597, 55598, 55599, 55675, 55676, 55677, 55678, 55683, 55684, 55775, 55776, 55777, 55778, 55790, 55791, 55792, 55793, 55794, 55852, 55853, 55854, 55855, 55856, 55948, 55949, 55951, 55952, 55953, 55991, 55992, 55993, 55994, 55995, 56109, 56110, 56111, 56123, 56159, 56160, 56161, 56162, 56163, 56189, 56193, 56195, 56196, 56216, 56218, 56219, 56387, 56388, 56389, 56391, 56464, 56465, 56466, 56467, 56468, 56528, 56529, 56530, 56531, 56532, 56533, 56534, 56661, 56662, 56663, 56664, 56741, 56742, 56829, 56830, 56831, 56832, 56833, 56846, 56847, 56848, 56928, 56929, 56930, 56931, 56932, 56933, 56935, 57063, 57177, 57178, 57179, 57226, 57227, 57268, 57269, 57270, 57271, 57272, 57273, 57439, 57440, 57560, 57561, 57562, 57563, 57564, 57565, 57567, 57884, 57885, 57947, 57948, 58257, 58258, 58363, 58364, 58564, 58566, 58567, 58568, 58897, 58898, 58899, 59249, 59337, 59338, 59339, 59909, 59910, 59911, 60264, 60265, 60682, 60683, 60684, 60685, 60763, 60764, 60765, 60774, 60775, 60776, 60876, 60877, 60880, 60881, 60882, 60883, 60884, 60886, 60887, 60888, 60889, 60890, 60891, 60892, 60893, 60894, 60895, 60896, 60897, 60898, 60899, 60900, 61189, 61190, 61191, 61192, 61193, 61254, 61257, 61262, 61264, 61312, 61313, 61314, 61315, 61598, 61599, 61600, 61605, 61606, 61607, 61612, 61613, 61617, 61925, 61928, 61935, 61936, 61937, 61944, 61946, 61953, 61960, 53106, 53107, 53388, 53449, 54420, 54618, 54929, 55028  Model Number VS-402:  GTIN 00613994384089, Serial Numbers: 53830, 54210, 54211, 54421, 55491 GTIN 00643169437937, Serial Numbers: 53841 GTIN 00643169931459, Serial Numbers: 53928 GTIN 20643169986262, Serial Numbers: 53821, 53834, 53835, 53842, 53843, 53845, 53894, 53896, 53900, 53926, 53927, 53929, 53938, 54141, 54212, 54214, 54215, 54216, 54217, 54218, 54220, 54221, 54222, 54287, 54288, 54289, 54291, 54292, 54318, 54320, 54321, 54323, 54325, 54360, 54362, 54363, 54367, 54371, 54372, 54393, 54395, 54422, 54549, 54550, 54552, 54555, 54558, 54559, 54567, 54568, 54695, 54696, 54697, 54698, 54777, 54779, 54780, 54791, 54792, 54793, 54830, 54831, 54834, 55076, 55077, 55110, 55111, 55112, 55227, 55357, 55443, 55444, 55489, 55601, 55602, 55679, 55680, 55686, 55687, 55779, 55782, 55796, 55797, 55860, 55861, 55955, 55959, 55962, 55963, 55971, 56113, 56115, 56116, 56164, 56165, 56166, 56167, 56197, 56198, 56199, 56200, 56201, 56220, 56221, 56222, 56384, 56385, 56386, 56469, 56470, 56471, 56472, 56473, 56535, 56536, 56537, 56641, 56736, 56737, 56739, 56740, 56818, 56819, 56820, 56821, 56822, 56823, 56824, 56825, 56826, 56827, 56840, 56841, 56842, 56843, 56844, 56845, 56937, 56938, 56939, 56940, 56941, 56942, 56943, 56944, 56945, 56946, 56947, 56948, 56949, 56950, 56951, 56952, 56953, 56954, 56955, 57077, 57082, 57180, 57181, 57182, 57183, 57184, 57185, 57186, 57228, 57229, 57230, 57231, 57232, 57233, 57234, 57235, 57236, 57237, 57274, 57275, 57276, 57277, 57278, 57279, 57280, 57281, 57282, 57283, 57284, 57285, 57286, 57287, 57288, 57289, 57290, 57291, 57296, 57297, 57298, 57299, 57568, 57569, 57570, 57571, 57572, 57573, 57574, 57575, 57576, 57577, 57578, 57579, 57580, 57581, 57582, 57583, 57584, 57586, 57587, 57588, 57589, 57590, 57591, 57592, 57593, 57594, 57595, 57596, 57597, 57598, 57599, 57600, 57601, 57602, 57603, 57604, 57605, 57606, 57607, 57608, 57886, 57887, 57888, 57889, 57949, 57950, 57951, 57952, 57953, 57954, 57955, 57962, 57963, 57964, 57965, 57966, 57967, 57968, 57969, 57970, 57971, 57972, 58057, 58058, 58059, 58060, 58061, 58062, 58081, 58082, 58083, 58084, 58085, 58101, 58102, 58103, 58104, 58105, 58107, 58108, 58109, 58110, 58111, 58112, 58113, 58193, 58194, 58195, 58259, 58260, 58261, 58262, 58356, 58357, 58358, 58359, 58360, 58378, 58379, 58380, 58381, 58382, 58383, 58384, 58385, 58386, 58387, 58388, 58389, 58415, 58416, 58417, 58418, 58419, 58420, 58421, 58422, 58423, 58424, 58425, 58426, 58427, 58428, 58429, 58430, 58431, 58432, 58433, 58434, 58435, 58436, 58437, 58438, 58439, 58440, 58441, 58442, 58569, 58570, 58571, 58572, 58573, 58602, 58603, 58604, 58605, 58609, 58610, 58611, 58612, 58613, 58614, 58615, 58616, 58617, 58618, 58619, 58620, 58621, 58622, 58623, 58624, 58625, 58626, 58627, 58628, 58629, 58630, 58631, 58632, 58633, 58634, 58635, 58636, 58637, 58638, 58639, 58640, 58641, 58642, 58643, 58644, 58645, 58646, 58647, 58839, 58901, 58902, 58903, 58904, 58905, 58906, 58907, 58908, 58988, 58989, 58990, 58991, 58992, 58993, 58994, 58995, 58996, 58997, 58998, 58999, 59000, 590… (truncated, 10590 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2021

Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)

Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
87483
Lot/product code:
Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021: 4105026 4122780 9925856 9961244 12333241 12333419 12333802 12334211 12334212 12334213 12334214 12334319 12334403 12334424 12334452 12334652 12334713 12334833 12334896 12334950 12334951 12334957 12335116 12335128 12335147 12335159 12335163 12335212 12335232 12335260 12335304 12335380 12335427 12335481 12335513 12335522 12335570 12335596 12335606 12335625 12335642 12335673 12335722 12335754 12335790 12335792 12335883 12335904 12335921 12335926 12335967 12335970 12336005 12336011 12336156 12336165 12336273 12336275 12336279 12336280 12336293 12336305 12336395 12336402 12336403 12336430 12336435 12336461 12336630 12336668 12336694 12336971 12337823 12421700 12517224 12524554 12524783 12544522 12568207 12570110 12570217 12571055 12580490 12586058 12586274 12586333 12587144 12588342 12590617 12590762 12591783 12591900 12592059 12592353 12592442 12592545 12592622 12592624 12592771 12592840 12592879 12592944 12592968 12592979 12593139 12593231 12594623 12595031 12595247 12595693 12595881 12595943 12595992 12596068 12596243 12596303 12597046 12597178 12597462 12597465 12597556 12597699 12598072 12598088 12598112 12598125 12640247 12640292 12641907 12650197 12655100 12740634 12743978 12744142 12755303 12767321 12779073 12793502 12793519 12793565 12793610 12815356 12822657 12822783 12823029 12823031 12823099 12823177 12827621 12828337 12875779 12876033 12877579 12897320 12961435 12993617 13022654 13057056 13066426 13066442 13066455 13066498 13066510 13066511 13066525 13066560 13066570 13066618 13066637 13066674 13066680 13066683 13066696 13066713 13066715 13066756 13066798 13066808 13066858 13066877 13066887 13066899 13066965 13067206 13067213 13067257 13067270 13067271 13067282 13067283 13067340 13067343 13067423 13067428 13067451 13067453 13067456 13067482 13067484 13067510 13067530 13067559 13067568 13067569 13067570 13067571 13067649 13067669 13067715 13067747 13067751 13067774 13067796 13067797 13067808 13067813 13067827 13067879 13067883 13067906 13067913 13067928 13067948 13067954 13067956 13067957 13067967 13068037 13068038 13068048 13068050 13068052 13068295 13068362 13068384 13068386 13070783 13108584 13166329 13211801 13212320 13315884 13421569 13489942 13499587 13530717 13530791 13557812 13558687 13559309 13569015 13571437 13585486 13586852 13587307 13588968 13589012 13592584 13592826 13592978 13593436 13595698 13595718 13596145 13596439 13596492 13596561 13596703 13596833 13596896 13597393 13597456 13597596 13597604 13597651 13597698 13597921 13597922 13598257 13599210 13599280 13599312 13599388 13599392 13599519 13599542 13599972 13600058 13600936 13601022 13601030 13601031 13601239 13604404 13604690 13605007 13605028 13605044 13605145 13605153 13605223 13605288 13605327 13605341 13605348 13605349 13605495 13605514 13605611 13605612 13605627 13605640 13605648 13605660 13605687 13605690 13605692 13605768 13605776 13605779 13605780 13605785 13605803 13605805 13605828 13605829 13605856 13605867 13605891 13605893 13605915 13605923 13605955 13606085 13606119 13606128 13606143 13606199 13606220 13606222 13606223 13606232 13606275 13606352 13606402 13606446 13606462 13606527 13606534 13606566 13606572 13606582 13606585 13606590 13606600 13606608 13606615 13606626 13606636 13606644 13606649 13606693 13606715 13606737 13606741 13606743 13606762 13606765 13606771 13606787 13606817 13606821 13606857 13606862 13606864 13606873 13606877 13606880 13606884 13606886 13606887 13606894 13606895 13606912 13606913 13606933 13606938 13606940 13606949 13606953 13606962 13606963 13606964 13606992 13606993 13607004 13607013 13607015 13607016 13607022 13607024 13607028 13607033 13607041 13607047 13607050 13607054 13607061 13607063 13607064 13607072 13607073 13607081 13607082 13607084 13607085 13607086 13607089 13607090 13607097 13607098 13607103 13607110 13607114 13607116 13607122 13607123 13607136 13607162 13607196 13607203 13607213 13607438 13607453 13607467 13607521 13607525 13607526 13607573 13607617 13607619 13607621 13607622 13607626 13607627 13607628 13607642 13607643 13607717 13607726 13610054 13610888 13610991 13612073 13613850 13613949 13614806 13615336 13616177 13616266 13616312 13617896 13618080 13618110 13618117 13618350 13618386 13618387 13618402 13618404 13618405 13618421 13618423 13618424 13618439 13618444 13618458 13618493 13618497 13618512 13618515 13618526 13618577 13618589 13618603 13618620 13618635 13618679 13618681 13618688 13618693 13618694 13618696 13618703 13618704 13618708 13618711 13618729 13618730 13618736 13618760 13618776 13618799 13618831 13618834 13618843 13618860 13618876 13618897 13618899 13618916 13618918 13618919 13618920 13618922 13618929 13618933 13618939 13618940 13618942 13618943 13618945 13618947 13618948 13618949 13618955 13618960 13618966 13618968 13618969 13618971 13618972 13618973 13618975 13618977 13618980 13618981 13618983 13618988 13618989 13618990 13618994 13618997 13618998 13619006 13619007 13619009 13619013 1361… (truncated, 22112 characters total — see the official FDA record for the full value)
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2021

cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

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

Recall #:
87622
Lot/product code:
All serial ID numbers
Recalling firm:
Roche Molecular Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2021

cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190

Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

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

Recall #:
87622
Lot/product code:
All lot numbers
Recalling firm:
Roche Molecular Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2021

Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.

There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.

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

Recall #:
87674
Lot/product code:
All serial numbers
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)