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Recalls affecting Oregon

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

16,620 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

ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.

ALL 50 STATES
Full report

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

Recall #:
88746
Lot/product code:
Serial Numbers:  US: BS16904 BS16905 BS16906 BS16909 BS16910 BS16911 BS16912 BS16913 BS16914 BS16915 BS16916 BS16917 BS16918 BS16921 BS16923 BS16925 BS17930 BS17934 BS17935 BS17936 BS17937 BS18900 BS18901 BS18924 BS18931 BS18938 BS18939 BS18940 BS18942 BS18943 BS18945 BS18946 BS18947 BS18948 BS18949 BS18950 BS18951 BS18952 BS18953 BS18954 BS18955 BS18956 BS18957 BS18958 BS18959 BS18960 BS18961 BS18962 BS18963 BS18964 BS18965 BS18966 BS18967 BS18968 BS18969 BS18970 BS18971 BS18972 BS18973 BS18974 BS18975 BS18976 BS18977 BS18979 BS18980 BS18981 BS18982 BS18983 BS18984 BS18985 BS18986 BS18987 BS18988 BS18989 BS18990 BS18991 BS18992 BS18993 BS18994 BS18995 BS18996 BS18997 BS18998 BS18999 BS19037 BS19038 BS19039 BS19040 BS19041 BS19043 BS19047 BS19049 BS19050 BS19052 BS19053 BS19054 BS19057 BS19058 BS19059 BS19060 BS19061 BS19065 BS20066 BS20067 BS20072 BS20073 BS20079 BS20080 BS20086 BS20092 BS20100 BS20103 BS20107 BS21112 BS21115 BS21121 BS21129 BS21137 BS21138  OUS:  BS15902 BS15903 BS16007 BS16919 BS16928 BS16929 BS17008 BS17010 BS17013 BS17021 BS17022 BS17023 BS18024 BS18026 BS18027 BS18028 BS18030 BS18031 BS19032 BS19033 BS19034 BS19035 BS19036 BS19042 BS19051 BS19056 BS19062 BS19064 BS20068 BS20069 BS20070 BS20071 BS20074 BS20075 BS20076 BS20077 BS20078 BS20082 BS20084 BS20085 BS20090 BS20095 BS20098 BS20099 BS20102 BS20105 BS20106 BS21108 BS21109 BS21114 BS21124 BS21128 BS21132 BS21133 BS21134
Recalling firm:
MEDTECH SAS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01

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 03573026223601, Lot #s: 1008603580, 1008748010, 1008888030, 1008584190, 1008647850
Recalling firm:
bioMerieux, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 22, 2021

VIDAS DEX@, Dimer Exclusion II, REF 30455-01

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 03573026387006, Lot #s: 1008696660,1008761020, 1008864290, 1008891690
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

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 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

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 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

DigitalDiagnost C90

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:
DigitalDiagnost C90
Recalling firm:
Philips Healthcare
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 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 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

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 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 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

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 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 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)