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Recalls affecting Kentucky

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

16,694 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 September 9, 2020

TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012913 2024716 2025341 2031135 2033510 2034402 2036289 2037671
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012722 2025144
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012912 2017844 2019840 2021496 2024714 2033500 2049663 2052725 2055727
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012909 2012911 2012910 2012937 2013912 2013913 2016202 2016230 2016203 2018636 2018637 2018740 2018795 2021326 2022258 2023091 2024440 2024441 2024439 2024448 2024449 2025098 2025094 2025340 2025287 2027419 2027388 2025288 2027453 2029073 2027483 2029325 2029326 2029366 2029365 2030990 2030989 2031123 2031125 2031127 2032788 2033240 2033239 2033375 2033376 2033497 2034385 2034386 2034387 2034458 2034459 2035471 2035472 2035473 2035521 2035522 2035523 2035524 2035526 2035525 2036692 2039227 2039228 2039424 2039584 2039585 2040072 2040706 2040708 2040709 2042563 2042564 2042565 2042745 2042746 2044792 2044794 2044795 2044796 2044797 2044793 2045742 2045743 2045744 2045745 2045746 2046744 2048188 2048189 2048190 2048191 2048192 2049661 2049662 2049655 2049656 2049657 2049658 2049660 2049659 2056309 2056311 2056310 2056312 2056313
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012769 2013999 2016154 2021495 2023224 2025101 2026924 2027418 2029364 2030912 2030913 2033496 2036691 2049654 2053758 2050886
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012768 2013311 2012721 2013998 2016127 2018633 2018634 2019989 2020049 2021384 2021453 2023181 2023223 2023335 2025106 2025286 2026922 2025140 2026921 2026923 2025339 2027417 2027452 2029072 2029363 2030909 2030910 2030911 2030985 2030983 2030984 2032785 2033372 2033373 2034382 2034383 2034384 2035515 2035516 2035517 2035518 2036275 2036276 2039986 2038899 2039421 2039422 2040069 2040070 2040071 2044789 2044790 2044791 2050884 2049652 2049653 2050885 2055771 2055772 2056306 2048187 2056871 2056307
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2012908 2016123 2017811 2018793 2018796 2019889 2023270 2024438 2025338 2027482 2029362 2032556 2033493 2034379 2034380 2034381 2036272 2036273 2038763 2050882 2050883 2049650 2049651 2053757 2056870
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2023195 2023243 2024953 2024956 2025090 2025122 2025379 2025380 2026563 2028643 2027357 2027362 2027367 2027371 2029177 2029178 2029179 2029180 2029213 2030836 2030837 2030853 2030854 2030869 2030870 2030871 2030872 2030883 2030884 2032840 2033307 2033418 2033554 2035383 2035384 2035403 2035404 2035413 2035428 2036762 2036763 2037209 2038262 2040397 2040398 2039496 2039175 2039633 2039634 2041088 2041089 2041214 2044784 2042798 2044783 2045734 2045735 2046221 2048174 2048173 2048175 2048176 2048177 2049628 2049629 2049630 2049631 2049632 2050866 2050867 2051658 2050868 2050869 2052035 2053332 2053334 2050865 2053333 2053335 2053336 2053337 2054832 2055528 2054776 2054777 2054778
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2025178
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2025421, 2038665,
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2025362, 2040057
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2044764
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2013904 2018628 2023177 2025213 2039590 2050959 2052719
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2027487 2031136 2033257 2034471 2038440 2050957 2053792 2056056
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2020371 2020372 2020373 2020995 2030838 2035405 2044636 2048178
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

ALL 50 STATES
Full report

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

Recall #:
86462
Lot/product code:
Batch Numbers: 2027380
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2020

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

ALL 50 STATES
Full report

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

Recall #:
90113
Lot/product code:
Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
Recalling firm:
Tandem Diabetes Care Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with weaker than it should be ethanol levels.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0038-2021
Lot/product code:
Lot #: 37009, Exp. 02/10/2021
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with weaker than it should be ethanol levels.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0037-2021
Lot/product code:
Lot #: 072120, Exp. 01/21/2022
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.

Weaker than it should be Drug; Killz GERMz was recalled due to weaker than it should be results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0040-2021
Lot/product code:
Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with weaker than it should be ethanol levels.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0039-2021
Lot/product code:
Lot #: 37009, Exp. 02/10/2021
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2020

Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

ALL 50 STATES
Full report

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

Recall #:
86419
Lot/product code:
Model 1600983 / Catalog number 1600983-001 Serial Numbers: 16D0002 16D0003 16D0004 16D0005 16D0006 16D0007 16D0008 16D0009 16D0010 16D0011 16D0012 16D0013 16D0014 16D0015 16D0016 16D0017 16D0018 16D0019 16D0020 16D0021 16D0022 16D0023 16D0024 16D0025 16D0026 16D0027 16D0028 16D0029 16D0030 16D0031 16D0032 16D0033 16D0034 16D0035 16D0036 16D0037 16D0038 16D0039 16D0040 16D0041 16D0042 16D0043 16D0044 16D0045 16D0046 16D0047 16D0048 16D0049 16D0050 16D0051 16E0001 16E0002 16E0003 16E0004 16E0005 16E0006 16E0007 16E0008 16E0009 16E0010 16E0011 16E0012 16E0013 16E0014 16E0015 16E0016 16E0017 16E0018 16E0019 16E0020 16E0021 16E0022 16E0023 16E0024 16E0025 16E0026 16E0027 16E0028 16E0029 16E0030 16E0031 16E0032 16E0033 16E0034 16E0035 16E0036 16E0037 16E0038 16E0039 16E0040 16E0041 16E0042 16E0043 16E0044 16E0045 16E0046 16E0047 16E0048 16E0049 16E0050 16F0001 16F0002 16F0003 16F0004 16F0005 16F0006 16F0007 16F0008 16F0009 16F0010 16F0011 16F0012 16F0013 16F0014 16F0015 16F0016 16F0017 16F0018 16F0019 16F0020 16F0021 16F0022 16F0023 16F0024 16F0025 16F0026 16F0027 16F0028 16F0029 16F0030 16H0001 16H0002 16H0003 16H0004 16H0005 16H0006 16H0007 16H0008 16H0009 16H0010 16H0011 16H0012 16H0013 16H0014 16H0015 16H0016 16H0017 16H0018 16H0019 16H0020 16H0021 16H0022 16H0023 16H0024 16H0025 16H0026 16H0027 16H0028 16H0029 16H0030 16I0001 16I0002 16I0003 16I0004 16I0005 16I0006 16I0007 16I0008 16I0009 16I0010 16I0011 16I0012 16I0013 16I0014 16I0015 16I0016 16I0017 16I0018 16I0019 16I0020 16I0021 16I0022 16I0023 16I0024 16I0025 16I0026 16I0027 16I0028 16I0029 16I0030 16I0031 16I0032 16I0033 16I0034 16I0035 16I0036 16I0037 16I0038 16I0039 16I0040 16J0001 16J0002 16J0003 16J0004 16J0005 16J0006 16J0007 16J0008 16J0009 16J0010 16J0011 16J0012 16J0013 16J0014 16J0015 16J0016 16J0017 16J0018 16J0019 16J0020 16J0021 16J0022 16J0023 16J0024 16J0025 16J0026 16J0027 16J0028 16J0029 16J0030 16K0001 16K0002 16K0003 16K0004 16K0005 16K0006 16K0007 16K0008 16K0009 16K0010 16K0011 16K0012 16K0013 16K0014 16K0015 16K0016 16K0017 16K0018 16K0019 16K0020 16K0021 16K0022 16K0023 16K0024 16K0025 16K0026 16K0027 16K0028 16K0029 16K0030 17D0001 17D0002 17D0003 17D0004 17D0005 17D0006 17D0007 17D0008 17D0009 17D0010 17D0011 17D0012 17D0013 17D0014 17D0015 17D0016 17D0017 17D0018 17D0019 17D0020 17D0021 17D0022 17D0023 17D0024 17D0025 17D0026 17D0027 17D0028 17D0029 17D0030 17D0031 17D0032 17D0033 17D0034 17D0035 17D0036 17D0037 17D0038 17D0039 17D0040 17D0041 17D0042 17F0001 17F0002 17F0003 17F0004 17F0005 17F0006 17F0007 17F0008 17F0009 17F0010 17F0011 17F0012 17F0013 17F0014 17F0015 17F0016 17F0017 17F0018 17F0019 17F0020 17F0021 17F0022 17F0023 17F0024 17F0025 17F0026 17F0027 17F0028 17F0029 17F0030 17F0031 17F0032 17F0033 17F0034 17F0035 17F0036 17F0037 17F0038 17F0039 17F0040 17F0041 17F0042 17F0043 17F0044 17F0045 17F0046 17F0047 17F0048 17F0049 17F0050 17F0051 17F0052 17F0053 17F0054 17F0055 17F0056 17F0057 17F0058 17F0059 17F0060 17F0061 17F0062 17F0063 17F0064 17F0065 17F0066 17F0067 18A0001 18A0002 18A0003 18A0004 18A0005 18A0006 18A0007 18A0008 18A0009 18A0010 18A0011 18A0012 18A0013 18A0014 18A0015 18A0016 18A0017 18A0018 18A0019 18A0020 18A0021 18A0022 18A0023 18A0024 18A0025 18A0026 18A0027 18A0028 18A0029 18A0030 18D0001 18D0002 18D0003 18D0004 18D0005 18D0006 18D0007 18D0008 18D0009 18D0010 18D0011 18D0012 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024
Recalling firm:
Bien-Air Surgery Sa
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2020

Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

ALL 50 STATES
Full report

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

Recall #:
86419
Lot/product code:
Model 1600517 / Catalog number 1600517-001 Serial Numbers: 18F0017 18F0030 18G0003 18G0018 18G0019 18G0020 18G0021 18G0025 18H0016 18H0017 18H0018 18H0019 18H0026 18H0027 18I0003 18I0004 18I0005 18I0006 18I0018 18I0022 18I0023 18I0024 18I0025 18I0026 18I0027 18I0028 18I0029 18I0030 18J0001 18J0002 18J0003 18J0004 18J0005 18J0009 18J0010 18J0011 18J0012 18J0013 18J0014 18J0015 18J0016 18J0017 18J0018 18J0019 18J0020 18J0021 18J0022 18J0023 18J0024 18J0025 18J0026 18J0037 18J0038 18J0039 18J0040 18J0041 18L0012 18L0014 18L0017 18L0018 18L0019 18L0020 18L0021 18L0023 19B0021 19B0022 19B0023 19B0024 19B0025 19B0028 19B0029 19B0030 19B0038 19B0041 19B0042 19B0043 19B0044 19B0051 19B0052 19B0053 19B0054 19B0055 19B0056 19B0058 19B0059 19E0004 19E0005 19E0008 19E0009 19E0011 19E0012 19E0013 19E0014 19E0015 19E0016 19E0017 19E0028 19E0029 19E0030 19E0035 19E0037 19E0047 19E0048 19E0053 19E0054 19E0055 19E0056 19E0057 19E0058 19E0060 19E0063 19E0064 19E0068 19E0069 16A0015 16A0016 16G0024 16I0007 16I0026 16I0027 16I0028 16I0029 16K0027 17A0009 17B0008 17B0009 17B0010 17B0011 17B0012 17B0013 17B0039 17B0040 17B0041 17B0049 17B0050 17C0012 17C0013 17E0033 17G0004 17G0024 17G0025 19E0006 19E0007 19E0010
Recalling firm:
Bien-Air Surgery Sa
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2020

Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

ALL 50 STATES
Full report

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

Recall #:
86419
Lot/product code:
Model 1600686 / Catalog number 1600686-001 Serial Numbers: 18D0006 18D0007 18D0008 18D0009 18D0010 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024 18D0025 18D0026 18D0027 18D0028 18D0029 18D0030 16A0005 16A0009 16A0010 16A0011 16A0014 17D0011 17G0006
Recalling firm:
Bien-Air Surgery Sa
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 11, 2020

Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427.

Weaker than it should be Drug; Killz GERMz was recalled due to weaker than it should be results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0041-2021
Lot/product code:
Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21
Recalling firm:
Genesis Partnership Company SA
View official FDA record (opens in a new tab)