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Recalls affecting Montana

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

16,414 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 PRG Progesterone, REF 30409-01

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 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS Measles IgG (MSG), REF 30219

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 03573026064532, Lot #: 1008890110
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS SARS-COV-2 IgG, Ref 423834-01

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 03573026620745, Lot #: 1008671430, 1008763910
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS LH, REF 30406-01

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 03573026156930, Lot #: 1008848600
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29

An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated

ALL 50 STATES
Full report

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

Recall #:
89800
Lot/product code:
Product name (build number) UDI-DI RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35) N/A RayStation 5 Service Pack 3 (5.0.3.17) 07350002010020 RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297 RayStation/RayPlan 10A (10.0.0.1154) 07350002010303 RayStation/RayPlan 10A Service Pack 1 (10.0.1.52) 07350002010365 RayStation/RayPlan 10B (10.1.0.613) 07350002010310 RayStation 11A (11.0.0.951) 07350002010389 RayStation 11A Service Pack 1 (11.0.1.29) 07350002010433
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)
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

VIDAS Lyme IgM II (LYM), REF 416436

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 03573026447151, Lot #: 1008636750, 1008768920, 1008857410
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS Lyme IgG II (LYM), REF 417401

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 03573026458270, Lot #: 1008714880, 1008824220
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

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 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

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

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 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 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 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 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)
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)
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)
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 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)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers:  0209001 0209002 0209003 0209004 0211001 0211002 0211003 0211004 0211005 0211006 0211007 0211008 0211009 0211010 0211011 0211012 0211013 0211014 0211015 0211016 0211017 0211018 0211019 0211020 0211021 0211022 0211023 0211024 0211025 0211026 0211027 0211028 0211029 0211030 0211031 0211032 0211033 0211034 0211035 0211036 0211037 0211038 0211039 0211040 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215020 0215021 0215022 0215023 0215024 0215025 0215026 0215027 0215028 0215029 0215030 0215031 0215032 0215033 0215034 0215035 0215036 0314014 0314014KF 0314019 0410001 0410002 0410003 0410004 0410005 0410006 0410007 0410008 0410009 0410010 0410011 0410012 0410013 0410014 0410015 0410016 0410017 0410018 0410019 0410020 0410021 0410022 0410023 0410024 0410025 0410026 0410027 0410028 0410029 0410030 0410031 0410032 0410033 0410034 0410035 0410036 0410037 0410038 0410039 0410040 0414009 0414010 0414011 0414013 0414015 0414016 0414019 0414021 0414023 0414024 0510001 0510002 0510003 0510004 0612001B 0612002B 0612003B 0612003BTP 0612004B 0612005B 0612006B 0612007B 0612008B 0612008BTP 0612009B 0612010B 0612011B 0612012B 0612013B 0612014B 0612015B 0612016B 0612017B 0612018B 0612019B 0612020B 0612021B 0612022B 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0612029B 0612030B 0612031B 0612032B 0612033B 0612034B 0612035B 0612036B 0612037B 0612038B 0612039B 0612040B 0613001C 0613002C 0613003C 0613004C 0613005C 0613006C 0613007C 0613008C 0613009C 0613010C 0613011C 0613012C 0613013C 0613014C 0613015C 0613016C 0613017C 0613018C 0613019C 0613020C 0613021C 0613022C 0613023C 0711001 0711002 0711003 0711004 0711005 0711006 0711007 0711008 0711009 0711010 0711011 0711012 0711013 0711014 0711015 0711016 0711017 0711018 0711019 0711020 0711022 0711023 0711024 0711025 0711027 0711028 0711029 0711030 0711031 0711032 0711033 0711034 0711035 0711036 0711037 0711038 0711039 0711040 0714001 0714002 0714003 0714004 0714004KF 0714005 0714006 0714007 0714008 0714009 0714009KF 0714010 0714011 0714012 0714013 0714014 0714015 0714016 0714017 0714018 0714019 0714020 0714021 0714022 0714023 0714024 0714025 0714026 0714027 0714028 0910012 0910013 0910014 0910015 0910016 0910017 0910018 0910019 0910020 0910021 0910022 0910023 0910024 0910025 0910026 0910027 0910028 0910029 0910030 0910031 0910032 0910033 0910034 0910035 0910036 0910037 0910038 0910039 0910040 0910041 0910042 0910043 0910044 0910045 0910046 0910047 0910048 0910049 0910050 0910051 0910052 0910053 0910054 0910055 0911002 0911003 1011001 1011002 1011003 1011004 1011005 1011006 1011007 1011008 1011009 1011010 1011011 1011012 1011013 1011014 1011015 1011016 1011017 1011018 1011019 1011020 1011021 1011022 1011023 1011024 1011025 1011026 1011027 1011028 1011029 1011030 1011031 1011032 1011033 1011034 1011035 1011036 1011037 1011038 1011039 1011040 1014001 1014002 1014003 1014004 1014004KF 1014005 1014006 1014007 1014008 1014009 1014010 1014011 1014011KF 1014012 1014013 1014014 1014015 1014016 1014017 1014018 1014019 1014020 1014020KF 1014021 1014022 1014023 1014024 1014025 1209005 1209006 1209007 1209008 1209009 1209010 1209011 1209012 1209013 1209014 1209015 1209016 1209017 1209018 1209019 1209020 1209021 1209022 1209023 1209024 1209025 1209026 1209027 1209028 1209029 1209030 1209031 1209032 1209033 1209034 1209035 1209036 1209037 1209038 1209039 1209040 1209041 1209042 1209043 1209044 1212001B 1212002B 1212003B 1212004B 1212005B 1212006B 1212007B 1212008B 1212008BTP 1212009B 1212010B 1212011B 1212012B 1212013B 1212014B 1212015B 1212016B 1212017B 1212018B 1212019B 1212020B 1212021B 1212022B 1212023B 1212024B 1212025B 2015030001 2015030002 2015050001 2015050002 2015050003 2015050004 2015050005 2015050006 2015050007 2015050008 2015050009 2015050010 2015050011 2015050012 2015050013 2015050014 2015050015 2015050016 2015050017 2015050018 2015050019 2015050020 2015050021 2015050022 2015050023 2015050024 2015050025 2015050026 2015050027 2015050028 2015050029 2015050030 2015050031 2015050032 2015050033 2015050034 2015050035 2015050036 2015050037 2015060001 2015060002 2015060003 2015060004 2015060005 2015060006 2015070001 2015070002 2015070003 2015070005 2015070006 2015070007 2015080001 2015080002 2015080003 2015080004 2015080005 2015080006 2015080007 2015080008 2015080009 2015080010 2015080011 2015080012 2015080013 2015080014 2015080015 2015080016 2015080017 2015080018 2015080019 2015080020 2015080021 2015080022 2015080023 2015080024 2015080025 2015090001 2015090002 2015090003 2015090004 2015090005 2015120001 2015120002 2015120003 2015120004 2015120005 2015120006 2015120007 2015120008 2015120009 2015120010 2015120011 2015120012 2015120013 2015120014 2015120015 2015120016 2015120017 2015120018 2015120019 2015120020 2015120021 2015120022 2015120023 2015120024 2015120025 2015120026 2015120027 2015120028 2015120029 2015120030 2016030001 2016030002 2016030003 2016030004 2016030… (truncated, 5904 characters total — see the official FDA record for the full value)
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 29, 2021

LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers:  Lot/Serial Number 0115001 0115001 0115001 0115002 0115003 0115004 0115005 0115005 0115006 0115007 0115007 0115008 0115009 0115010 0115011 0115012 0115012 0115013 0115014 0115015 0115015 0115016 0115017 0115018 0115019 0115020 0115021 0115022 0115023 0115024 0115025 0115026 0115027 0115028 0115029 0115030 0115031 0115032 0115033 0115034 0115035 0115036 0115037 0115038 0115039 0115040 0215001 0215003 0215004 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215019 0215020 0215021 1114001 1114002 1114003 1114004 1114005 1114006 1114007 1114008 1114009 1114010 1114011 1114012 1114013 1114013 1114014 1114015 1114016 1114017 1114018 1114019 1114020 1114021 1114022 1114023 1114024 1114025 1114026 1114027 1114028 1214001 1214002 1214003 1214004 1214005 1214005 1214006 1214007 2015060001 2015060002 2015060003 2015060004 2015060004 2015060005 2015060006 2015060007 2015060008 2015060009 2015060010 2015060011 2015060011 2015060012 2015060013 2015060014 2015080001 2015080002 2015080003 2015080004 2015080005 2015080006 2015080007 2015080008 2015080009 2015080010 2015080011 2015080012 2015080013 2015080014 2015080015 2015080016 2015080016 2015080017 2015080018 2015080019 2015080020 2015080021 2015080022 2015080023 2015080023 2015080024 2015080025 2015090005 2015090006 2015090007 2015090008 2015090009 2015090010 2015090011 2015090012 2015090013 2015090013 2015090014 2015090015 2015090015 2015090016 2015090017 2015100001 2015100002 2015100003 2015100004 2015110001 2015110002 2015110003 2015110004 2015110005 2015110006 2015110007 2015110007 2015110008 2015110009 2015110010 2015110011 2015110012 2015110013 2015110014 2015110015 2015110016 2015110017 2015110018 2015110019 2016020001 2016020002 2016020003 2016020004 2016020004 2016020005 2016020006 2016020007 2016020008 2016020009 2016020010 2016020011 2016020012 2016020012 2016020013 2016020014 2016020015 2016020016 2016020017 2016020018 2016020019 2016030001 2016030002 2016030003 2016030003 2016030004 2016030005 2016030006 2016030007 2016030008 2016030009 2016030010 2016030011 2016030012 2016030013 2016030014 2016030015 2016030016 2016030017 2016040003 2016040004 2016040005 2016040006 2016040007 2016040008 2016040009 2016040010 2016040011 2016050001 2016050002 2016050003 2016050004 2016050005 2016050006 2016050007 2016050008 2016050009 2016050010 2016050011 2016050012 2016050013 2016050014 2016050015 2016050016 2016050017 2016050018 2016050019 2016050020 2016050021 2016050022 2016050023 2016050024 2016050025 2016050026 2016050027 2016050028 2016050029 2016050030 2016050031 2016050032 2016050033 2016050034 2016060001 2016060002 2016060003 2016060004 2016060005 2016060006 2016060007 2016060008 2016060009 2016060009 2016060010 2016060011 2016060012 2016060013 2016060014 2016060015 2016060016 2016060017 2016060018 2016060019 2016060020 2016060021 2016060022 2016060023 2016060024 2016060025 2016060026 2016060027 2016060028 2016060028 2016060029 2016060031 2016070001 2016070002 2016070003 2016070004 2016070005 2016070005 2016070006 2016070007 2016070008 2016070008 2016070009 2016070010 2016070011 2016070012 2016070013 2016070014 2016070015 2016070016 2016070017 2016070018 2016070019 2016070020 2016070023 2016070024 2016070025 2016070026 2016070027 2016070027 2016070028 2016070029 2016070030 2016070031 2016080001 2016080002 2016080003 2016080004 2016080005 2016080006 2016080007 2016080008 2016080009 2016080010 2016080010 2016080011 2016080012 2016080013 2016080014 2016080015 2016080016 2016080017 2016080018 2016080019 2016080020 2016080021 2016080022 2016080023 2016080024 2016080025 2016080026 2016080026 2016080027 2016080029 2016080030 2016080031 2016080032 2016100001 2016100002 2016100003 2016100004 2016100005 2016100006 2016100007 2016100008 2016100009 2016100010 2016100011 2016100012 2016100013 2016100014 2016100015 2016100016 2016100017 2016100018 2016100019 2016100021 2016100022 2016100023 2016100024 2016100025 2016100026 2016100027 2016100028 2016100029 2016100030 2016100031 2016100032 2016100033 2016100033 2016100034 2016100035 2016120001 2016120002 2016120003 2016120004 2016120005 2016120006 2016120007 2016120008 2016120009 2016120010 2016120011 2017010005 2017010006 2017010007 2017010008 2017010008 2017010009 2017010010 2017010011 2017010012 2017010013 2017010014 2017010015 2017010016 2017010017 2017010018 2017010019 2017010020 2017010021 2017010023 2017010024 2017020006 2017020006 2017020007 2017020008 2017020009 2017020010 2017020011 2017020012 2017020013 2017020014 2017020015 2017020016 2017020017 2017020018 2017020019 2017020020 2017040001 2017040002 2017040003 2017040004 2017040005 2017040006 2017040007 2017040008 2017040009 2017040010 2017040011 2017040012 2017040013 2017040014 2017050001 2017050002 2017050003 2017050004 2017050005 2017050006 2017050007 2017050008 2017050008 2017050009 2017050010 2017050011 2017050012 2017050013 2017050014 2017060001 2017060002 201706000… (truncated, 17167 characters total — see the official FDA record for the full value)
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)