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Recalls affecting Kentucky

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

16,729 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

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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

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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

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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)

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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.

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 21, 2022

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

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

Recall #:
89675
Lot/product code:
Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
Recalling firm:
NeuMoDx Molecular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 21, 2022

1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.

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

Recall #:
89413
Lot/product code:
1. Footrest, REF: 03282000, UDI: 05713464000336;  Serial Numbers: 903282000046, 903282000057, 903282000075 ,9032820000070, 903282000001, 903282000002, 903282000004 thru 903282000006, 903282000009, 903282000011, 903282000012 903282000015, 903282000016, 903282000018 thru 903282000020, 903282000023, 903282000024, 903282000025, 903282000026, 903282000028, 903282000032 thru 903282000034, 903282000036, 903282000038 thru 903282000042, 903282000044, 903282000045, 903282000047 thru 903282000051, 903282000053, 903282000055, 903282000056, 903282000058 thru 903282000061, 903282000063, 903282000064, 903282000067, 903282000068  2. Shoulder Support, REF: 03283000, UDI: 05713464000381 Serial Numbers: 903283000012, 903283000028, 903283000001 thru 903283000003, 903283000005, 903283000010, 903283000011, 903283000013 thru 903283000022, 903283000023, 903283000024, 903283000026
Recalling firm:
NRT X-RAY A/S
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 24, 2022

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

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

Recall #:
89439
Lot/product code:
1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022  2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
Recalling firm:
Argon Medical Devices, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2022

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

Excessive ultraviolet-C radiation

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

Recall #:
90860
Lot/product code:
Model Seago SG-153
Recalling firm:
IN MY BATHROOM LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2022

HeartWare Ventricular Assist Device (HVAD) System

Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.

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

Recall #:
89559
Lot/product code:
All lots/serials for the following product model numbers: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650, 1650CA-CLIN, 1650DE
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2022

MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860; MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862; MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The MiniMed" 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older.

New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.

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▸Full report

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

Recall #:
89653
Lot/product code:
Insulin pumps distributed in the last 6 months. All devices (US) serial numbers ranging from NG2056884H TO NG2891033H and (OUS) serial numbers ranging from NG1921788H TO NG2883091
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2022

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

Failed stability specifications for reagent kits that may result in false negative test results.

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

Recall #:
89533
Lot/product code:
Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 28, 2022

Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).

Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.

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

Recall #:
89697
Lot/product code:
[lot 21253BB, UDI: 0084276801569421253BB22091010445158840], [lot 21263BA UDI: 0084276801569421263BA22092010445158840], [lot 21335AA, UDI: 0084276801569421335AA22120110445158840]
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 28, 2022

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.

Weaker than it should be Drug: FDA analysis has revealed some bottles of these products were weaker than it should be for ethanol.

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

Recall #:
D-0647-2022
Lot/product code:
All lots within expiry and labelled as 'Made in the USA'
Recalling firm:
AMS Packaging Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 28, 2022

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

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

Recall #:
89576
Lot/product code:
Version 2.0.x (v2.0.0, v2.0.1, v2.0.2, or v2.0.3) with serial numbers beginning with SKN for the MAI700 Integrated, UDI 00840682109666 and serial numbers beginning with SNF for the MAI700 Integrated, UDI 0100840682109604; or serial numbers beginning with SNF for the MAS700 Desktop, UDI 00840682109604.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 28, 2022

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.

Weaker than it should be Drug: FDA analysis has revealed some bottles of these products were weaker than it should be for ethanol.

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-0646-2022
Lot/product code:
All lots within expiry and labelled as 'Made in the USA'
Recalling firm:
AMS Packaging Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 31, 2022

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

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

Recall #:
89527
Lot/product code:
REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)
Recalling firm:
SD Biosensor, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 31, 2022

Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system

Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.

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

Recall #:
89703
Lot/product code:
Serial Numbers: 20113 23071 20118 22523 23021 22169 23164 22388 22119 22844 21209 23699 21114 22190 22146 22126 22128 22836 22163 22727 22135 22347 21174 22676 22029 22895 22917 22920 22058 22847 22852 22655 22708 22275 22254 22928 22857 22208 22071 23130 22092 22175 21194 23602 23018 23019 22076 22630 21108 22919 22825 22054 22177 20105 22998 20115 22104 22966 23625 23627 22748 22352 22353 22354 22618 21004 21005 22136 23059 22914
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 31, 2022

INFX-8000V. For radiographic and fluoroscopic studies and intervention.

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.

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

Recall #:
90737
Lot/product code:
Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 1, 2022

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

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

Recall #:
89758
Lot/product code:
All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Recalling firm:
Mevion Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 2, 2022

NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair

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

Recall #:
89721
Lot/product code:
Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Recalling firm:
Ace Surgical Supply Co., Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 2, 2022

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

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

Recall #:
89787
Lot/product code:
UDI: (01)00884838059030(21)839 (01)00884838085275(21)131 (01)00884838059054(21)577 (01)00884838085350(21)81 (01)00884838085367(21)271 (01)00884838054202(21)879 (01)00884838054202(21)1783 (01)00884838054202(21)1447 (01)00884838099241(21)282 (01)00884838099258(21)512 (01)00884838099258(21)360 (01)00884838099258(21)370 (01)00884838099258(21)584 (01)00884838099272(21)239 (01)00884838099258(21)425 (01)00884838099258(21)232 (01)00884838099258(21)591 (01)00884838099258(21)580 (01)00884838099258(21)39 (01)00884838099241(21)198 (01)00884838099258(21)589 (01)00884838099258(21)362 (01)00884838085268(21)954 (01)00884838099234(21)10 (01)00884838099241(21)214 (01)00884838099272(21)183 (01)00884838099258(21)526 (01)00884838099258(21)441 (01)00884838099272(21)121 (01)00884838099258(21)80 (01)00884838099258(21)326 (01)00884838099258(21)518 (01)00884838099258(21)404 (01)00884838099241(21)252 (01)00884838099258(21)453 (01)00884838099258(21)472 (01)00884838099258(21)465 (01)00884838099272(21)129 (01)00884838099272(21)174 (01)00884838099258(21)553 (01)00884838099258(21)517 (01)00884838099258(21)400 (01)00884838099258(21)342 (01)00884838099258(21)582 (01)00884838099241(21)196 (01)00884838085268(21)1391 (01)00884838099258(21)485 (01)00884838099258(21)262 (01)00884838099258(21)277 (01)00884838099272(21)120 (01)00884838085268(21)703826 (01)00884838085367(21)38 (01)00884838085367(21)36 (01)00884838085275(21)139 (01)00884838085268(21)1199 (01)00884838085251(21)940 (01)00884838085251(21)945 (01)00884838085251(21)947 (01)00884838085268(21)703680 (01)00884838085251(21)964 (01)00884838085268(21)703724 (01)00884838085268(21)703541 (01)00884838085268(21)703815 (01)00884838085251(21)991 (01)00884838085251(21)1013 (01)00884838085251(21)943 (01)00884838085251(21)1025 (01)00884838085282(21)417 (01)00884838054202(21)511 (01)00884838085268(21)559 (01)00884838085268(21)560 (01)00884838085268(21)340 (01)00884838085350(21)45 (01)00884838085268(21)703560 (01)00884838054202(21)810 (01)00884838085350(21)272 (01)00884838085350(21)256 (01)00884838054189(21)364 (01)00884838054189(21)164 (01)00884838054189(21)1250 (01)00884838059030(21)226 (01)00884838059030(21)860 (01)00884838054189(21)1105 (01)00884838085251(21)464 (01)00884838085268(21)703523 (01)00884838085268(21)703524 (01)00884838085268(21)1418 (01)00884838085268(21)1209 (01)00884838085268(21)1427 (01)00884838085268(21)703537 (01)00884838085268(21)703538 (01)00884838085268(21)703517 (01)00884838085268(21)1426 (01)00884838054202(21)305 (01)00884838054196(21)139 (01)00884838085251(21)1003 (01)00884838085251(21)207 (01)00884838085251(21)209 (01)00884838085251(21)211 (01)00884838085251(21)447 (01)00884838085268(21)232 (01)00884838054189(21)412 (01)00884838054202(21)1547 (01)00884838054219(21)59 (01)00884838054240(21)92 (01)00884838085251(21)1005 (01)00884838085251(21)220 (01)00884838085251(21)799 (01)00884838099258(21)221 (01)00884838099227(21)62 (01)00884838099241(21)201 (01)00884838099241(21)185 (01)00884838099258(21)145 (01)00884838099258(21)257 (01)00884838099258(21)352 (01)00884838099258(21)353 (01)00884838099272(21)141 (01)00884838099258(21)368 (01)00884838099241(21)132 (01)00884838099241(21)165 (01)00884838099241(21)117 (01)00884838099241(21)195 (01)00884838099258(21)555 (01)00884838099241(21)267 (01)00884838099241(21)268 (01)00884838099241(21)271 (01)00884838099241(21)270 (01)00884838099241(21)255 (01)00884838099241(21)224 (01)00884838099227(21)56 (01)00884838099241(21)287 (01)00884838099241(21)114 (01)00884838099258(21)67 (01)00884838099241(21)239 (01)00884838099241(21)249 (01)00884838099241(21)141 (01)00884838099258(21)783 (01)00884838099258(21)531 (01)00884838099227(21)28 (01)00884838099241(21)142 (01)00884838099241(21)235 (01)00884838099241(21)227 (01)00884838085268(21)703959 (01)00884838099258(21)600 (01)00884838099241(21)348 (01)00884838099241(21)176 (01)00884838099258(21)634 (01)00884838099241(21)321 (01)00884838099241(21)123 (01)00884838099227(21)32 (01)00884838099227(21)72 (01)00884838099203(21)8 (01)00884838099227(21)64 (01)00884838099234(21)46 (01)00884838099241(21)91 (01)00884838099227(21)2 (01)00884838099265(21)4 (01)00884838099241(21)95 (01)00884838099241(21)283 (01)00884838099234(21)21 (01)00884838099234(21)22 (01)00884838099241(21)295 (01)00884838099272(21)140 (01)00884838099227(21)5 (01)00884838099227(21)6 (01)00884838099227(21)7 (01)00884838099227(21)74 (01)00884838099241(21)218 (01)00884838099265(21)38 (01)00884838099227(21)40 (01)00884838099227(21)15 (01)00884838099272(21)166 (01)00884838099227(21)47 (01)00884838099227(21)48 (01)00884838099227(21)13 (01)00884838099241(21)140 (01)00884838099241(21)9 (01)00884838099241(21)49 (01)00884838099241(21)20 (01)00884838099241(21)157 (01)00884838099258(21)597 (01)00884838099258(21)810 (01)00884838099272(21)171 (01)00884838099258(21)413 (01)00884838099241(21)76 (01)00884838085268(21)304 (01)00884838099203(21)48 (01)00884838099210(21)27 (01)00884838099258(21)270 (01)00884838099227(21)52 (01)00884838099258(21)416 (01)00884838099203(21)45 (… (truncated, 10074 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2022

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

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

Recall #:
89604
Lot/product code:
Serial numbers AS1001 through AS1387 UDIs: (01)00380740138479(21)AS1002 (01)00380740138479(21)AS1005 (01)00380740138479(21)AS1009 (01)00380740138479(21)AS1012 (01)00380740138479(21)AS1013 (01)00380740138479(21)AS1016 (01)00380740138479(21)AS1019 (01)00380740138479(21)AS1023 (01)00380740138479(21)AS1028 (01)00380740138479(21)AS1031 (01)00380740138479(21)AS1032 (01)00380740138479(21)AS1044 (01)00380740138479(21)AS1058 (01)00380740138479(21)AS1064 (01)00380740138479(21)AS1097 (01)00380740138479(21)AS1126 (01)00380740138479(21)AS1148 (01)00380740138479(21)AS1153 (01)00380740138479(21)AS1155 (01)00380740138479(21)AS1160 (01)00380740138479(21)AS1161 (01)00380740138479(21)AS1193 (01)00380740138479(21)AS1212 (01)00380740138479(21)AS1213 (01)00380740138479(21)AS1215 (01)00380740138479(21)AS1217 (01)00380740138479(21)AS1218 (01)00380740138479(21)AS1219 (01)00380740138479(21)AS1220 (01)00380740138479(21)AS1221 (01)00380740138479(21)AS1222 (01)00380740138479(21)AS1224 (01)00380740138479(21)AS1225 (01)00380740138479(21)AS1226 (01)00380740138479(21)AS1227 (01)00380740138479(21)AS1230 (01)00380740138479(21)AS1231 (01)00380740138479(21)AS1233 (01)00380740138479(21)AS1234 (01)00380740138479(21)AS1235 (01)00380740138479(21)AS1236 (01)00380740138479(21)AS1237 (01)00380740138479(21)AS1238 (01)00380740138479(21)AS1240 (01)00380740138479(21)AS1241 (01)00380740138479(21)AS1242 (01)00380740138479(21)AS1243 (01)00380740138479(21)AS1246 (01)00380740138479(21)AS1247 (01)00380740138479(21)AS1248 (01)00380740138479(21)AS1249 (01)00380740138479(21)AS1250 (01)00380740138479(21)AS1251 (01)00380740138479(21)AS1252 (01)00380740138479(21)AS1253 (01)00380740138479(21)AS1254 (01)00380740138479(21)AS1255 (01)00380740138479(21)AS1256 (01)00380740138479(21)AS1257 (01)00380740138479(21)AS1259 (01)00380740138479(21)AS1261 (01)00380740138479(21)AS1262 (01)00380740138479(21)AS1263 (01)00380740138479(21)AS1264 (01)00380740138479(21)AS1266 (01)00380740138479(21)AS1267 (01)00380740138479(21)AS1268 (01)00380740138479(21)AS1269 (01)00380740138479(21)AS1270 (01)00380740138479(21)AS1271 (01)00380740138479(21)AS1272 (01)00380740138479(21)AS1273 (01)00380740138479(21)AS1274 (01)00380740138479(21)AS1275 (01)00380740138479(21)AS1276 (01)00380740138479(21)AS1277 (01)00380740138479(21)AS1278 (01)00380740138479(21)AS1279 (01)00380740138479(21)AS1280 (01)00380740138479(21)AS1281 (01)00380740138479(21)AS1282 (01)00380740138479(21)AS1283 (01)00380740138479(21)AS1284 (01)00380740138479(21)AS1285 (01)00380740138479(21)AS1286 (01)00380740138479(21)AS1287 (01)00380740138479(21)AS1288 (01)00380740138479(21)AS1289 (01)00380740138479(21)AS1290 (01)00380740138479(21)AS1291 (01)00380740138479(21)AS1293 (01)00380740138479(21)AS1294 (01)00380740138479(21)AS1295 (01)00380740138479(21)AS1296 (01)00380740138479(21)AS1299 (01)00380740138479(21)AS1300 (01)00380740138479(21)AS1301 (01)00380740138479(21)AS1302 (01)00380740138479(21)AS1303 (01)00380740138479(21)AS1304 (01)00380740138479(21)AS1305 (01)00380740138479(21)AS1306 (01)00380740138479(21)AS1307 (01)00380740138479(21)AS1309 (01)00380740138479(21)AS1310 (01)00380740138479(21)AS1311 (01)00380740138479(21)AS1312 (01)00380740138479(21)AS1313 (01)00380740138479(21)AS1314 (01)00380740138479(21)AS1315 (01)00380740138479(21)AS1316 (01)00380740138479(21)AS1317 (01)00380740138479(21)AS1318 (01)00380740138479(21)AS1319 (01)00380740138479(21)AS1320 (01)00380740138479(21)AS1321 (01)00380740138479(21)AS1322 (01)00380740138479(21)AS1323 (01)00380740138479(21)AS1325 (01)00380740138479(21)AS1326 (01)00380740138479(21)AS1327 (01)00380740138479(21)AS1330 (01)00380740138479(21)AS1332 (01)00380740138479(21)AS1333 (01)00380740138479(21)AS1334 (01)00380740138479(21)AS1336 (01)00380740138479(21)AS1341 (01)00380740138479(21)AS1344 (01)00380740138479(21)AS1346 (01)00380740138479(21)AS1347 (01)00380740138479(21)AS1348 (01)00380740138479(21)AS1349 (01)00380740138479(21)AS1350 (01)00380740138479(21)AS1351 (01)00380740138479(21)AS1352 (01)00380740138479(21)AS1353 (01)00380740138479(21)AS1354 (01)00380740138479(21)AS1355 (01)00380740138479(21)AS1358 (01)00380740138479(21)AS1359 (01)00380740138479(21)AS1360 (01)00380740138479(21)AS1368
Recalling firm:
Abbott Laboratories, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2022

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.

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

Recall #:
89698
Lot/product code:
MM-TSMs with bottom protective beams
Recalling firm:
Volcano Corp
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodChemicalRecalled February 3, 2022

Saladitos With Chili, Net Weight 16 oz (1lb) with UPC 0661799748162. The product is packaged in ultra clear sealed zip-lock plastic bag. There is no expiry date and no lot code.

Elevated levels of lead

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

Recall #:
F-0824-2022
Lot/product code:
The product has no manufacturing code and no expiration date.
Recalling firm:
A & E Corrales LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2022

Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS

There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

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

Recall #:
89672
Lot/product code:
ALL LOTS
Recalling firm:
Philips North America LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2022

Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS

There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

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

Recall #:
89672
Lot/product code:
ALL LOTS
Recalling firm:
Philips North America LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 7, 2022

The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.

Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.

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

Recall #:
89791
Lot/product code:
All lots manufactured IFUs from 2008 to present. UDI for probe model 21075A (01)00884838000995, model 21076A (01)00884838001008, model 21078A (01)00884838001015, model 989803162621 (01)00884838008045, model 989803162631 (01)00884838008052, and model 989803162641 (01) 00884838008069
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 7, 2022

Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01

Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.

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

Recall #:
D-0573-2022
Lot/product code:
lot# 25910009, Exp 01/2023
Recalling firm:
RISING PHARMACEUTICALS
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugUndeclaredRecalled February 7, 2022

70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765

Labeling - product contains not listed on the label ethyl alcohol

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

Recall #:
D-0635-2022
Lot/product code:
Lot#: 39,40,41,42,43,44 and 45
Recalling firm:
Tsm Brands LLC
View official FDA record (opens in a new tab)