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Recalls affecting Texas

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

17,556 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

MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984

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: 2042787
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

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

TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616

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: 2025074 2027489 2031006 2042572 2052109 2056058
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290

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: 2012935 2013910 2016229 2017812 2018635 2019990 2021454 2022268 2024711 2025147 2027400 2029394 2030945 2037184 2038460 2038795 2039253 2039444 2045859 2045858 2045860 2045861 2048368 2049884 2048367
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291

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: 2012936 2013911 2016129 2018794 2027463 2029395 2033280
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983

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: 2034103 2034102 2034104 2042786
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697

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: 2013959 2016246 2017861 2018756 2019936 2021510 2023286 2024791 2025371 2027465 2027498 2027403 2029347 2031019 2031087 2031153 2033535 2035497 2035534 2037188 2037148 2038325 2039607 2041068 2042774 2044894 2046452 2048384 2048385 2049906 2051015 2051016 2052167 2052166 2056074 2056423 2056424 2057383
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707

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: 2011426 2011425 2011427 2014000 2014001 2016191 2016231 2016190 2017773 2017813 2017845 2018741 2018798 2018852 2019891 2019890 2020050 2021455 2021497 2021545 2023183 2023182 2023271 2024718 2024720 2024722 2027219 2027436 2027406 2029150 2029352 2029399 2030953 2030954 2031092 2031093 2031157 2031158 2032824 2032825 2033399 2033398 2033538 2033537 2035454 2035455 2035540 2035541 2036290 2036696 2037152 2038469 2038804 2038805 2039452 2039453 2039454 2039455 2041421 2041071 2041072 2041073 2041074 2042598 2042779 2042778 2045871 2045872 2045873 2045874 2045875 2044895 2046745 2048396 2048397 2048398 2048401 2048402 2048403 2049922 2049923 2049917 2049918 2048399 2049919 2049920 2049921 2051017 2051018 2051019 2052178 2052181 2052179 2052180 2052182 2052183 2053917 2053918 2053919 2053920 2056083 2053915 2056082 2048400 2056429 2056430 2056431 2057399 2057400 2057401
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 9, 2020

HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708

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: 2014002 2016196 2017814 2020051 2021388 2023272 2024724 2026266 2024759 2025289 2027469 2030955 2031023 2033400 2035501 2036291 2038328 2039263 2048404 2049924 2051020 2053921 2056432 2057402
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 ULTRA-Absorbable Suture anchors Product Number:72200777

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: 2012914, 2033371
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 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631

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: 2012720 2024445 2052779 2055899
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 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620

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: 2025072
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)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2020

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

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 1600407 / Catalog number 1600407-001 Serial Numbers: 16C0017 16F0013 16I0009 16K0017 17F0039 17I0015 17L0013
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, 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

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)
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)
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)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2020

Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.

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 1600998 / Catalog number 1600998-001 Serial Numbers: 17K0059 19A0042 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 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 16L0001 16L0002 16L0003 16L0004 16L0005 16L0006 16L0007 16L0008 16L0009 16L0010 16L0011 16L0012 16L0013 16L0014 16L0015 16L0016 16L0017 16L0018 16L0019 16L0020 16L0021 16L0022 16L0023 16L0024 16L0025 16L0026 16L0027 16L0028 16L0029 16L0030 17A0001 17A0002 17A0003 17A0004 17A0005 17A0006 17A0007 17A0008 17A0009 17A0010 17A0011 17A0012 17A0013 17A0014 17A0015 17A0016 17A0017 17A0018 17A0019 17A0020 17A0021 17A0022 17A0023 17A0024 17A0025 17A0026 17A0027 17A0028 17A0029 17A0030 17C0001 17C0002 17C0003 17C0004 17C0005 17C0006 17C0007 17C0008 17C0009 17C0010 17C0011 17C0012 17C0013 17C0014 17C0015 17C0016 17C0017 17C0018 17C0019 17C0020 17C0021 17C0022 17C0023 17C0024 17C0025 17C0026 17C0027 17C0028 17C0029 17C0030 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 17E0001 17E0002 17E0003 17E0004 17E0005 17E0006 17E0007 17E0008 17E0009 17E0010 17E0011 17E0012 17E0013 17E0014 17E0015 17E0016 17E0017 17E0018 17E0019 17E0020 17E0021 17E0022 17E0023 17E0024 17E0025 17E0026 17F0001 17F0002 17F0003 17F0004 17F0005 17F0006 17F0007 17F0008 17F0009 17F0010 17F0011 17F0012 17F0013 17F0014 17F0015 17F0016 17F0017 17F0018 17F0019 17F0020 17F0021 17F0022 17G0001 17G0002 17G0003 17G0004 17G0005 17G0006 17G0007 17G0008 17G0009 17G0010 17G0011 17G0012 17G0013 17G0014 17G0015 17G0016 17G0017 17G0018 17G0019 17G0020 17G0021 17G0022 17G0023 17G0024 17G0025 17G0026 17G0027 17G0028 17G0029 17G0030 17I0001 17I0002 17I0003 17I0004 17I0005 17I0006 17I0007 17I0008 17I0009 17I0010 17I0011 17I0012 17I0013 17I0014 17I0015 17I0016 17I0017 17I0018 17I0019 17I0020 17I0021 17I0022 17I0023 17I0024 17I0025 17I0026 17I0027 17I0028 17I0029 17I0030 17I0031 17I0032 17I0033 17J0002 17J0003 17J0004 17J0005 17J0006 17J0007 17J0008 17J0009 17J0010 17J0011 17J0012 17J0013 17J0014 17J0015 17J0016 17J0017 17J0018 17J0019 17J0020 17J0021 17J0022 17J0023 17J0024 17J0025 17J0026 17J0027 17J0028 17J0029 17J0030 17K0001 17K0002 17K0003 17K0004 17K0005 17K0006 17K0042 17K0043 17K0044 17K0045 17K0046 17K0047 17K0048 17K0049 17K0050 17K0051 17K0052 17K0053 17K0054 17K0055 17K0056 17K0057 17K0058 17K0060 18D0001 18D0002 18D0003 18D0004 18D0005 18D0006 18D0007 18D0008 18D0009 18D0010 18D0011 18D0012 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024 18D0025 18D0026 18D0027 18D0028 18D0029 18D0030 18D0031 18D0032 18D0033 18D0034 18D0035 18D0036 18D0037 18D0038 18D0039 18D0040 18D0041 18D0042 18D0043 18D0044 18D0045 18D0046 18D0047 18D0048 18D0049 18D0050 18D0051 18D0052 18D0053 18D0054 18D0055 18D0056 18D0057 18D0058 18D0059 18D0060 18F0001 18F0002 18F0003 18F0004 18F0005 18F0006 18F0007 18F0008 18F0009 18F0010 18F0011 18F0012 18F0013 18F0014 18F0015 18F0016 18F0017 18F0018 18F0019 18F0020 18F0021 18F0022 18F0023 18F0024 18F0025 18F0026 18F0027 18F0028 18F0029 18F0030 18L0001 18L0002 18L0004 19A0001 19A0002 19A0003 19A0004 19A0005 19A0006 19A0007 19A0008 19A0009 19A0010 19A0011 19A0012 19A0013 19A0014 19A0015 19A0016 19A0017 19A0018 19A0019 19A0020 19A0021 19A0022 19A0023 19A0024 19A0025 19A0026 19A0027 19A0028 19A0029 19A0030 19A0031 19A0032 19A0033 19A0034 19A0035 19A0036 19A0037 19A0038 19A0039 19A0045 19A0046 19A0047 19A0048 19A0049 19A0050 19A0051 19A0052 19A0053 19A0054 19A0055 19A0056 19A0057 19A0058 19A0059 19A0060 19C0001 19C0002 19C0003 19C0004 19C0005 19C0006 19C0007 19C0008 19C0011 19C0012 19C0013 19C0014 19C0015 19C0016 19C0017 19C0018 19C0019 19C0020 19C0021 19C0022 19C0023 19C0024 19C0025 19C0026 19C0027 19C0029 19C0030
Recalling firm:
Bien-Air Surgery Sa
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2020

Synapse PACS Software Versions 5.1 and higher

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

ALL 50 STATES
Full report

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

Recall #:
86532
Lot/product code:
Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
Recalling firm:
Fujifilm Medical Systems U.S.A., 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)