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Recalls affecting Kentucky

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

16,729 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 January 6, 2022

FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

ALL 50 STATES
Full report

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

Recall #:
89449
Lot/product code:
Manufactured from April 1, 2021 to September 15, 2021. 120421-a 70921 30521 180621d 010421 140621a 060721a 120421-b 270521 130521a 090721a 060421-a 140621b 060721b 120421-c 030621 130521b 090721b 060421-b 140621c 060721c 220421-a 160721a 130521c 130721a 060421-c 150621a 060721d 220421-b 160721b 200521a 130721b 080421-a 150621b 070721a 220421-c 180721 200521b 130721c 080421-b 150621c 070721b 230621a 280721 200521c 130721d 080421-c 210621a 070721c 230621b 290721 250521a 300821a 130421-a 210621b 070721d 230621c 100821 250521b 300821b 130421-b 210621c 080721a 230621d 100821 250521c 310821a 130421-c 210621d 080721b 170721a 090621c 310521a 210721a 200421-a 220621a 080721c 170721b 180721a 310521b 210721b 200421-b 220621b 080721d 190721 180721b 310521c 210721c 200421-c 220621c 120721a 290721a 180721c 070621a 40821 260421-a 220621d 120721b 290721b 180721d 070621b 60821 260421-b 300621a 120721c 290721c 190721a 070621c 130821 260421-c 300621b 120721d 90821 190721b 110621a 090921-2 270421-a 300621c 140721a 110821 160821 110621b 100921 270421-b 300621d 140721b 120821 270821 110621c 140921-1 270421-c 050721a 140721c 190821 190421a 180621a 140921-2 030521 050721b 140721d 230821 190421b 190621b 140921-3 040521a 050721c 150721a 240821 190421c 180621c 140921-4 040521b 050721d 200721a 070421-a 210421-a 260521a 290621a 040521c 310821b 200721b 070421-b 210421-b 260521b 290621b 170521a 010921a 200721c 070421-c 210421-c 160621a 290621c 170521b 010921b 200721d 170821 280721a 160621b 290621d 170521c 020921a 300721a 180821 280721b 160621c 280621a 180521a 020921b 300721b 110521 280721c 160621d 280621b 180521b 030921a 300721c 200821 030821a 170721 280621c 180521c 030921b 50821 020621 030821b 140421-b 280621d 190521a 070921 200421 030821c 140421-a 020821a 090621a 080921 250821 130921-1 180821b 020821b 090621b 080921-2 260821 130921-2 100921-2 020821c 090921 140421-c
Recalling firm:
Envisiontec US Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

ALL 50 STATES
Full report

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

Recall #:
93737
Lot/product code:
UDI-DI 00884838009820 Ingenia Serial number 41045 Accessory Serial Number 100018
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2022

BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200

May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts

ALL 50 STATES
Full report

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

Recall #:
89486
Lot/product code:
All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

ALL 50 STATES
Full report

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

Recall #:
89619
Lot/product code:
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Recalling firm:
Orthosoft, Inc. dba Zimmer CAS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

There are lower than expected MICs for some gram negative species.

ALL 50 STATES
Full report

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

Recall #:
89416
Lot/product code:
Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)
Recalling firm:
Remel Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080

Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.

ALL 50 STATES
Full report

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

Recall #:
89389
Lot/product code:
Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
Recalling firm:
Compass Health Brands (Corporate Office)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

MODEL: X-RAY TV SYSTEM SONIALVISION G4

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

Full report

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

Recall #:
89596
Lot/product code:
Model: SonialVision G4 Generator Number: D150-40 Serial Numbers: 41C35166C003 41C3536B4001 41C351683006 41C3516B3001 41C35169C002 41C351699002 41C351699001 41C3517AA001 41C35169B002 41C351671001 41C3516A3001 41C351661002 41C351671007 41C351683003 41C351671005 41C35179B004 41C351674001 41C35168B002 41C3517AA002 41C351685004 41C35165B002 41C3535A5001 41C353597001 41C35359C001 41C351674004 41C351685003 41C35164C001 41C351641001 41C351671004 41C351679001 41C3535A1001 41C3535A3001 41C351664004 41C351679006 41C351684004 41C351674002 41C3535A2002 41C351669002 41C351646002 41C35164A001 41C35359C002 41C351692001 41C35168B001 41C351653004 41C351664002 41C351673004 41C351663002 41C35164B001 41C351683001 41C351683002 41C351799001 41C351686002 41C351646001 41C351679005 41C351693003 41C351665002 41C35179A001 41C35165A003 41C35168A003 41C35179B005 41C35179B003 41C351671006 41C351689001 41C351799002 41C351641002 41C351671002 41C351676002 41C35165A001 41C351643001 41C35165A002 41C351655001 41C351695003 41C351647001 41C35166A002 41C351693002 41C351695001 41C351664005 41C351673003 41C35166C001 41C3535AC001 41C35166A001 41C35168B003 41C35169C001 41C3517B1001 41C3518B4002 41C351653002 41C3518B4001 41C35168A004 41C351665003 41C351678002 41C351684001 41C351683005 41C351693001 41C351671003 41C35179C001 41C351677001 41C35167A001 41C35165B001 41C351676001 41C351662001 41C35168C002 41C351668002 41C351679004 41C351677002 41C35179B001 41C351684005 41C351692003 41C351653003 41C351666002 41C351682002 41C351685001 41C351677003 41C353597002 41C3517A2002 41C351661001 41C35168C005 41C35168A002 41C35169A001 41C351663001 41C351692004 41C35168C004 41C351664001 41C351681001 41C351651002 41C351684006 41C3535A2001 41C351679007 41C351799003 41C351667001 41C351678001 41C351683004 41C351681002 41C351656001 41C351655003 41C3516B3002 41C3517B3002 41C3518B5001 41C3518B5002 41C3518B7001 41C3536B7001 41C351656002 41C35166C002 41C35168C001 41C351679002 41C351651001 41C351686001 41C351692002 41C3517A2001 41C35168A001 41C35166A003 41C351665001 41C351659001 41C3535A3002 41C351653005 41C351684003 41C3517A3001 41C351685002 41C3517A3002 41C351688001 41C351666001 41C351673002 41C351793001 41C351641003 41C351682001 41C351673001 41C35169B001 41C351695002 41C351655002 41C351679003 41C35168C003 41C35179B002 41C3517B1002 41C3517B3001 41C351668001 41C351669001 41C351654002
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

MODEL: X-RAY TV SYSSTEM SONIALVISION safire17

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

Full report

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

Recall #:
89596
Lot/product code:
Model: SonialVision safire: Generator Number: D150-40 Serial Numbers: 3M5249D41006 3M5249D2A004 3M5249D34001 3M5249D37006 3M5249D32012 3M5249D35002 3M5249D1C013 3M5249D31009 3M5249D29002 3M5249D33003 3M5249D2C004 3M5249D22013
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

Full report

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

Recall #:
89596
Lot/product code:
Model: FLUOROspeed X1 Generator Number: D150-40 Serial Numbers: MQ493E19C001 MQ493E3B8002 MQ493E3B9001 MQ493E1B4001 MQ493E1A1003 MQ493E1A3001 MQ493E1B5001 MQ493E3B8001 MQ493E1A5001 MQ493E1A1005 MQ493E1A2001 MQ493E1A4001 MQ493E1B6002 MQ493E1A8001 MQ493E1B4002 MQ493E1A4003 MQ493E1A4002 MQ493E1B6001 MQ493E1A2002 MQ493E1AC001 MQ493E1A1002 MQ493E19C002 MQ493E1A3003 MQ493E1A1004 MQ493E1A3002
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Everest MI XT Inner Dilator, Catalog Number 5101-90167

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

ALL 50 STATES
Full report

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

Recall #:
89522
Lot/product code:
GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Recalling firm:
K2M, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Everest MI XT Outer Dilator, Catalog Number 5101-90168

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

ALL 50 STATES
Full report

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

Recall #:
89522
Lot/product code:
GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
Recalling firm:
K2M, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)