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Recalls affecting Texas

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

17,591 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 22, 2021

VIDAS RUB IgG (RBG), REF 30226

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

ProxiDiagnost N90 is multi-functional general R/F systems.

The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

ALL 50 STATES
Full report

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

Recall #:
89023
Lot/product code:
ProxiDiagnost N90
Recalling firm:
Philips Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026229146, Lot #s: 1008730880
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS Mumps IgG (MPG), REF 30218

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026064525, Lot #: 1008769120
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026263010, Lot #: 1008861590
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

CombiDiagnost R90 is multi-functional general R/F systems.

The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.

ALL 50 STATES
Full report

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

Recall #:
89023
Lot/product code:
CombiDiagnost R90
Recalling firm:
Philips Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS SARS-COV-2 IgM, Ref 423833-01

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026620738, Lot #: 1008710950
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS FSH, REF 30407-01

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026156947, Lot #: 1008781470
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS Estradiol II, REF 30431-01

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026161637, Lot #: 1008757880
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS Clostridium Difficile GDH, REF 30125-01

BioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

ALL 50 STATES
Full report

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

Recall #:
88797
Lot/product code:
UDI 03573026444204, Lot #s: 1008686690
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.

ALL 50 STATES
Full report

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

Recall #:
89109
Lot/product code:
All da Vinci SP Surgical systems with software version OS4 v4.0.0 (P4_B327)
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 23, 2021

SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.

ALL 50 STATES
Full report

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

Recall #:
88825
Lot/product code:
Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022
Recalling firm:
DiaSorin Molecular LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 23, 2021

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Packaged dental implant contains a different size then the size declared on the labeling.

ALL 50 STATES
Full report

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

Recall #:
88859
Lot/product code:
lot # 166297 / UDI: 10841307101789
Recalling firm:
Implant Direct Sybron Manufacturing LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 23, 2021

ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

Packaged dental implant contains a different size then the size declared on the labeling.

ALL 50 STATES
Full report

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

Recall #:
88859
Lot/product code:
lot # 166300 / UDI: 10841307101796
Recalling firm:
Implant Direct Sybron Manufacturing LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 23, 2021

Clinician Programmer Application (CPA) model A610 Clinician Software Application

A software anomaly may occur with the clinician programmer application.

ALL 50 STATES
Full report

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

Recall #:
88761
Lot/product code:
Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 24, 2021

Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.

ALL 50 STATES
Full report

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

Recall #:
89020
Lot/product code:
Azurion 2.1(L1) and 2.1(L2)
Recalling firm:
Philips Healthcare
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 24, 2021

Permobil TiLite, Models: Aero Z, and ZRA

Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.

ALL 50 STATES
Full report

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

Recall #:
88718
Lot/product code:
Manufactured between January 19, 2017 and June 14, 2021 with the serial number range from M2005054 to 1231112011
Recalling firm:
TiSport, Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 24, 2021

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815

Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient

ALL 50 STATES
Full report

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

Recall #:
88820
Lot/product code:
Artis zeego systems with Artis patient table and AppSW VD20C/VD20N
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 27, 2021

HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

ALL 50 STATES
Full report

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

Recall #:
88846
Lot/product code:
All lots of the following sizes: a. XS, REF 47459, UDI (01)20680651474593 b. S, REF 47460, UDI (01)20680651474609 c. M, REF 47461, UDI (01)20680651474616 d. L, REF 47462, UDI (01)20680651474623 e. XL, REF 47463, UDI (01)20680651474630
Recalling firm:
O&M HALYARD INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2021

Atellica IM 1300 Analyzer, SMN 11066001

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

ALL 50 STATES
Full report

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

Recall #:
88792
Lot/product code:
All units
Recalling firm:
Siemens Healthcare Diagnostics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2021

Atellica IM 1600 Analyzer, SMN 11066000

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

ALL 50 STATES
Full report

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

Recall #:
88792
Lot/product code:
All units.
Recalling firm:
Siemens Healthcare Diagnostics, Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 28, 2021

Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0256-2022
Lot/product code:
a) Lots: 152838, 152156, 152151, 151708, 151693, 151375, 151131, 151114, Exp: 7/31/2022, b) Lots: 152245, 151822, 151708, 151160, 151131, Exp: 7/31/2022, c) Lot #: 152614, Exp: 7/31/2022.
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 28, 2021

The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4

Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8

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-0364-2022
Lot/product code:
Lot 2091A, exp 7/2023
Recalling firm:
Revive Personal Products Company
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 28, 2021

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0257-2022
Lot/product code:
a) Lots: 164865, Exp: 2/28/2021; 162113, Exp: 8/31/2022; 160419, Exp: 2/28/2023; 160004, 155752, 154380, 153776, 152889, Exp: 8/31/2022, b) Lots: 157837, 154997, Exp: 8/31/2022, c) Lots: 165687, 160419, 160330, Exp: 2/28/2023; 159973, 159943, 159352, 159345, 158841, 155752, 152347, Exp: 8/31/2022; 152245, 152156, 152197, 151338, 151160, Exp: 7/31/2022, d) Lots: 162641, Exp: 2/28/2023; 154380, 153776, 152889, Exp: 8/31/2022, e)Lots: 158841, 152889, Exp: 8/31/2022, f) Lots: 153776, 153735, 152347, Exp: 8/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;

Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

Full report

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

Recall #:
88880
Lot/product code:
Product Description/List Number ARCHITECT c4000 Module List Number: 2P24 UDI: (01)00380740003746(21)c4123456(240)02P2401 Serial Numbers: C400000 C400010 C400011 C400012 C400013 c400014 c400015 C400016 C400017 C400018 C400019 C400020 C400023 C400024 C400025 C400026 C400027 C400030 C400031 C400032 C400034 C400035 C400036 C400038 C400039 C400040 C400041 C400042 C400043 C400045 C400046 C400047 C400049 C400050 C400051 C400053 C400054 C400055 C400056 C400057 C400058 C400060 C400061 C400062 C400063 C400064 C400065 c400066 C400067 C400068 C400069 C400070 C400071 C400072 C400073 C400074 C400075 C400077 C400078 C400079 C400080 C400081 C400083 C400084 C400085 C400086 C400087 C400089 C400090 C400091 C400092 C400093 C400095 C400096 C400098 C400099 C400100 C400101 C400102 C400104 C400105 C400106 C400107 C400108 C400109 C400112 C400114 C400115 C400116 C400117 C400118 C400119 C400120 C400121 C400122 C400123 C400124 C400125 C400127 C400129 C400132 C400133 C400134 C400135 C400136 C400137 c400139 C400140 C400141 C400142 C400143 C400144 C400145 C400146 C400147 C400148 C400149 C400150 C400151 C400152 C400153 C400154 C400155 C400156 C400157 C400158 C400159 C400160 C400161 C400162 C400163 C400164 C400165 C400166 C400167 C400168 C400169 C400170 C400171 C400172 C400173 C400174 C400175 C400176 C400177 C400178 C400179 C400182 C400183 C400184 C400185 C400186 C400187 C400188 C400189 C400190 C400191 C400192 C400195 C400196 C400197 C400199 C400200 C400201 C400202 C400203 C400204 C400205 C400206 C400207 C400209 C400210 C400211 C400212 C400213 C400214 C400215 C400217 C400218 C400220 C400222 C400223 C400224 C400227 c400228 C400229 C400230 C400231 C400232 C400234 C400235 C400236 C400237 C400238 C400239 C400240 C400241 C400242 C400243 C400244 C400245 C400246 C400247 C400248 C400250 C400251 C400252 C400253 C400254 C400256 C400258 C400259 C400260 C400261 C400262 C400263 C400264 C400266 C400268 C400269 C400270 C400271 C400273 C400274 C400275 C400276 C400277 C400278 c400279 C400280 C400281 C400282 C400283 C400284 C400285 C400287 C400288 C400289 C400290 C400291 C400292 C400293 C400294 C400295 C400296 C400297 C400298 C400299 C400300 C400301 C400302 C400303 C400304 C400305 C400306 C400307 C400309 C400310 C400312 C400313 C400315 C400316 C400317 C400318 C400319 C400320 C400321 C400322 C400324 C400325 C400326 C400327 C400328 C400329 C400331 C400332 C400333 C400334 C400335 C400337 C400338 C400340 C400341 C400342 C400344 C400345 C400347 C400348 C400349 C400350 C400351 C400352 C400354 C400355 C400356 C400357 C400358 C400359 C400362 C400363 C400364 C400365 C400366 C400367 C400368 C400369 C400370 C400371 C400373 C400374 C400375 C400376 C400377 C400378 C400379 C400380 C400381 C400382 C400383 C400384 C400385 C400386 C400387 C400388 C400389 C400390 C400391 C400392 C400393 C400394 C400395 C400397 C400398 C400399 C400400 C400402 C400403 C400404 C400405 C400406 C400407 C400408 C400409 C400410 C400411 C400412 C400413 C400414 C400415 C400416 c400417 C400418 C400419 C400420 C400422 C400423 C400424 C400425 C400426 C400427 C400428 C400429 C400430 C400431 C400432 C400433 C400434 C400435 C400436 C400437 C400439 C400440 c400442 C400443 C400444 C400445 C400446 C400447 C400448 C400449 C400450 C400451 C400453 C400454 C400455 C400456 C400457 C400459 C400460 C400461 C400463 C400464 C400465 C400466 C400467 C400468 C400469 C400470 C400471 C400472 C400473 C400474 C400475 C400476 C400477 C400478 C400479 C400480 C400481 C400482 C400483 C400484 C400485 C400486 C400487 C400488 C400489 c400490 C400491 C400492 C400493 c400494 C400495 C400496 C400497 C400498 C400499 C400500 C400501 C400502 C400503 C400504 C400505 C400508 C400509 C400510 C400511 C400512 C400513 C400514 C400515 C400516 C400518 c400519 C400520 C400521 C400522 C400523 C400524 C400525 C400526 C400527 C400528 C400529 C400530 C400531 C400532 C400533 C400534 C400535 C400536 C400537 C400538 C400539 C400540 c400541 C400542 C400543 C400544 C400545 C400546 C400547 C400548 C400549 c400550 C400551 C400552 C400554 c400555 C400556 C400557 C400558 C400559 C400560 C400561 C400562 C400563 C400564 C400565 C400566 C400567 C400568 C400569 C400570 C400571 C400572 C400573 C400574 C400575 C400576 C400577 C400578 C400579 C400580 C400581 C400582 C400583 C400584 C400585 C400586 C400587 C400588 C400589 C400590 C400591 C400593 C400594 C400595 C400596 C400597 C400598 C400599 C400600 C400601 C400602 C400603 C400604 C400605 C400606 C400607 C400608 c400609 C400610 C400611 C400612 C400614 C400616 C400617 C400618 C400619 C400620 C400621 C400622 C400623 C400624 C400625 C400626 C400627 C400629 C400630 C400631 C400632 C400633 C400634 C400635 C400636 C400637 C400638 C400639 C400640 C400641 C400642 C400643 C400645 C400646 C400647 C400648 C400649 C400650 C400651 C400652 C400653 C400654 C400655 C400656 C400657 C400658 C400659 C400660 C400661 C400662 C400663 c400664 C400665 C400666 C400667 C400668 C400669 C400670 c400671 c400672 C400673 C400675 C400676 C400677 C400678 C400679 C400680 C400681 C400682 C400683 C400684 C400685 C400686 C400687 C400688 C400689 C400690… (truncated, 99077 characters total — see the official FDA record for the full value)
Recalling firm:
Abbott Laboratories
View official FDA record (opens in a new tab)