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Recalls affecting Kentucky

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

16,694 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

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸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

▸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 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

ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788

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: 353885393102 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

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

REF Spinning Spiros Closed Male Luer - 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: CH2000S CH2000S-10 CH2000S-C CH2000SC-10 CH2000SC-5 CH2000SC-5 CH2050  UDI: (01) 1 0840619 033900 (17) 260101 (30) 100 (10) 5125299 (01) 1 0840619 03391 7 (17) 260101 (30) 50 (10) 5142922 (01) 1 0840619 02661 2 (17) 260101 (30) 50 (10) 5125303 (01) 1 0840619 04276 6 (17) 260101 (30) 50 (10) 5142969 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5125289 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5142945 (01) 1 0887709 12231 1 (17) 260101 (30) 25 (10) 5125288  Lot Number: 5125299 5142922 5125303 5142969 5125289 5142945 5125288
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, 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: CH3235  UDI: (01) 1 0840619 03403 7 (17) 260101 (30) 50 (10) 5125276  Lot Number: 5125276
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.

ALL 50 STATES
▸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

DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

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: 8627005303 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

ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443

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: 353885994255 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

OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326

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: 8373982700 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 CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

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: CH3582  UDI: (01) 1 0887709 07925 7 (17) 260101 (30) 50 (10) 5125197  Lot Number: 5125197
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 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

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: 57599080000 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

ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862

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: 365702493100 All lots 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 K7040-001 Spinning Spiros Closed Male 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: K7040-001  UDI: (01) 1 0887709 036793 (17) 260101 (30) 100 (10) 5135765 (01) 1 0887709 036793 (17) 260101 (30) 100 (10) 5142935  Lot Number: 5135765 5142935
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/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: CL3538   UDI: (01) 1 0887709 07190 9(17) 260101 (30) 50 (10) 5125294  Lot Number: 5125294
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 16, 2021

REF 20130-01 Spinning Spiros Closed Male Luer, 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: 20130-01  UDI: (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5135750 (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5142982  Lot Number: 5135750 5142982
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

ALL 50 STATES
▸Full report

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 17, 2021

Change Healthcare Enterprise Viewer

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

AKAZCAFLHIIAILINKYMINENYOHPATXWAWIWY
▸Full report

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

Recall #:
87616
Lot/product code:
Change Healthcare Enterprise Viewer 2.0 and 2.1
Recalling firm:
CHANGE HEALTHCARE CANADA COMPANY
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 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, 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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 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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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 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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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
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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).

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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.
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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)