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Recalls affecting Guam

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

15,987 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 June 30, 2021

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures

The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.

ALL 50 STATES
Full report

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

Recall #:
88367
Lot/product code:
Serial Numbers: 20504835, 20504836, 20504837, 20504838, 20504839, 20556338, 20556369, 20556370, 20615320, 20615321, 20639217, 20639218, 20639219, 20639223, 20639224, 20639225, 20639226, 20639230, 20665290, 20693154, 20693155, 20693156, 20693157, 20693158, 20693159, 20693160, 20693161, 206E0051, 206E0058, 206E0059, 203R8980, 203R8981, 203R8986, 203R8987, 203R8988, 203R9022, 203R9023, 203R9031, 203R9032, 203R9033, 203R9034, 203R9035, 203R9036, 203R9037, 203R9038, 203R9041, 203R9042, 203R9047, 203R9048, 204J8480, 204J8481, 204J8482, 204J8483, 204J8484, 204Q3434, 204Q3435, 204S3741, 204S3742, 204S3746, 204S3747, 204S3755, 204S3757, 204S3758, 204S3759, 204S3760, 204S3773, 204U7420, 205B5697, 205B5703, 205B5713, 205F1090, 205F1091, 205F1092, 205F1093, 205F1095, 205F1097, 205F1109, 205F1110, 205F1119, 205Q9088, 205Q9089, 205Q9090, 205Q9091, 205Q9099, 206G6141, 206G6149, 206G6150, 206G6151, 206G6152, 206G6153, 206G6154, 206G6155, 206G6156, 206G6157, 206G6158, 206G6164, 206G6166, G3002072, G3002073, G3002074, G3002076, G3002077, G3002078, G3002079, G3002080, G3002081, G3002082, G3002083, G3002084, G3002086, G3002087, G3002088, G3002089, G3002090, G3002091, G3009910, G3009911, G3009972, G3009973, G3009974, G3020256, G3020257, G3020265, G3020270, G3020271, G3020276, G3020282, G3020283, G3020284, G3020285, G3020286, G3020287, G3020288, G3020289, G3020290, G3020291, G3020292, G3020293, G3020294, G3042776, G3054934, G3054935, G3056539, G3056540, G3056541, G3056542, G3056543, G3056544, G3056545, G3056546, G3056547, G3056548, G3056549, G3056550, G3056551, G3056552, G3056555, G3072337, G3072338, G3072339, G3072340, G3072341, G3072364, G3073380, G3079843
Recalling firm:
Hitachi Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

ALL 50 STATES
Full report

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

Recall #:
88208
Lot/product code:
Revolution CT
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

Revolution Apex, Revolution CT with Apex Edition

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

ALL 50 STATES
Full report

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

Recall #:
89762
Lot/product code:
Revolution Apex, Revolution CT with Apex Edition
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

ALL 50 STATES
Full report

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

Recall #:
89027
Lot/product code:
Revolution CT,  Revolution CT ES,  Revolution Apex,  Revolution CT with Apex edition
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2021

Revolution CT, Revolution CT ES

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

ALL 50 STATES
Full report

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

Recall #:
89762
Lot/product code:
Revolution CT, Revolution CT ES
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 1, 2021

GlideScope Go Monitors

Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.

Full report

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

Recall #:
88214
Lot/product code:
Part Number: 0570-0366 Software Version: v.1.4 Serial Numbers: 1450070 HM082506; HM171547; HM171548; HM171550; HM171622; HM171627; HM171629; HM171630; HM171631; HM171632; HM171633; HM171634; HM171635; HM171636; HM171637; HM171638; HM171639; HM171642; HM171643; HM171644; HM171645; HM171653; HM171654; HM171655; HM171678; HM171683; HM171685; HM171687; HM171688; HM171689; HM171690; HM171691; HM171692; HM171693; HM171695; HM171707; HM171709; HM171747; HM171748; HM171749; HM171750; HM171751; HM171752; HM171753; HM171754; HM171755; HM171758; HM171759; HM171760; HM171761; HM171763; HM171764; HM171794; HM171799; HM171800; HM171801; HM171802; HM171803; HM171804; HM171806; HM171807; HM171808; HM171809; HM171810; HM171811; HM171812; HM171813; HM171814; HM171815; HM171816; HM171817; HM171819; HM171820; HM171821; HM171822; HM171823; HM171824; HM171825; HM171826; HM171827; HM171828; HM171829; HM171830; HM171832; HM171833; HM171834; HM171836; HM171837; HM171838; HM171839; HM171840; HM171841; HM171843; HM171844; HM171846; HM171847; HM171848; HM171849; HM171850; HM171852; HM171853; HM171854; HM171857; HM171859; HM171860; HM171861; HM171862; HM171863; HM171864; HM171865; HM171866; HM171870; HM171871; HM171874; HM171875; HM171890; HM171891; HM171892; HM171893; HM171894; HM171895; HM171897; HM171898; HM171899; HM171900; HM171915; HM171916; HM171917; HM171918; HM171919; HM171920; HM171921; HM171922; HM171923; HM171924; HM171925; HM171926; HM171927; HM171928; HM171929; HM171930; HM171931; HM171932; HM171934; HM171935; HM171936; HM171937; HM171938; HM171939; HM171940; HM171941; HM171942; HM171953; HM171954; HM171955; HM171956; HM171957; HM171958; HM171959; HM171960; HM171961; HM171962; HM171964; HM171965; HM171966; HM171967; HM171968; HM171969; HM171970; HM171975; HM171976; HM171977; HM171979; HM171980; HM171981; HM171982; HM171983; HM171984; HM171985; HM171986; HM171987; HM171988; HM171989; HM171990; HM171991; HM171992; HM171993; HM171994; HM171995; HM172013; HM172021; HM172023; HM172024; HM172025; HM172026; HM172027; HM172028; HM172030; HM172032; HM172043; HM172044; HM172047; HM172048; HM172049; HM172050; HM172051; HM172052; HM172053; HM172054; HM172055; HM172056; HM172057; HM172059; HM172061; HM172062; HM172063; HM172064; HM172065; HM172066; HM172067; HM172068; HM172069; HM172070; HM172071; HM172072; HM172073; HM172074; HM172074; HM172075; HM172076; HM172077; HM172078; HM172079; HM172080; HM172081; HM172082; HM172083; HM172085; HM172087; HM172089; HM172090; HM172093; HM172094; HM172095; HM172096; HM172097; HM172098; HM172100; HM172101; HM172102; HM172103; HM172104; HM172105; HM172106; HM172107; HM172108; HM172109; HM172110; HM172111; HM172112; HM172114; HM172115; HM172116; HM172117; HM172118; HM172120; HM172121; HM172122; HM172123; HM172124; HM172128; HM172129; HM172130; HM172141; HM172142; HM172143; HM172144; HM172145; HM172146; HM172147; HM172149; HM172150; HM172151; HM172152; HM172153; HM172154; HM172155; HM172156; HM172157; HM172158; HM172159; HM172160; HM172161; HM172162; HM172163; HM172164; HM172165; HM172166; HM172167; HM172168; HM172169; HM172170; HM172172; HM172173; HM172174; HM172175; HM172176; HM172177; HM172180; HM172181; HM172182; HM172183; HM172184; HM172185; HM172186; HM172187; HM172188; HM172189; HM172190; HM172191; HM172193; HM172194; HM172195; HM172196; HM172197; HM172198; HM172199; HM172201; HM172202; HM172203; HM172204; HM172205; HM172206; HM172207; HM172208; HM172209; HM172210; HM172211; HM172212; HM172213; HM172214; HM172215; HM172216; HM172217; HM172218; HM172221; HM172222; HM172223; HM172224; HM172225; HM172226; HM172227; HM172228; HM172229; HM172230; HM172231; HM172232; HM172233; HM172234; HM172235; HM172236; HM172237; HM172238; HM172239; HM172240; HM172241; HM172242; HM172243; HM172244; HM172245; HM172246; HM172247; HM172248; HM172249; HM172250; HM172251; HM172252; HM172253; HM172254; HM172255; HM172256; HM172257; HM172258; HM172259; HM172260; HM172261; HM172262; HM172263; HM172264; HM172265; HM172267; HM172268; HM172269; HM172270; HM172271; HM172272; HM172273; HM172275; HM172276; HM172277; HM172278; HM172279; HM172280; HM172282; HM172283; HM172284; HM172285; HM172286; HM172287; HM172288; HM172289; HM172290; HM172291; HM172292; HM172293; HM172294; HM172295; HM172296; HM172297; HM172298; HM172299; HM172300; HM172301; HM172302; HM172303; HM172304; HM172305; HM172306; HM172307; HM172308; HM172309; HM172310; HM172311; HM172312; HM172313; HM172314; HM172315; HM172316; HM172317; HM172318; HM172319; HM172320; HM172321; HM172322; HM172323; HM172325; HM172326; HM172327; HM172328; HM172329; HM172330; HM172331; HM172333; HM172334; HM172335; HM172336; HM172338; HM172339; HM172340; HM172341; HM172342; HM172344; HM172345; HM172346; HM172347; HM172348; HM172349; HM172350; HM172351; HM172352; HM172353; HM172354; HM172355; HM172356; HM172357; HM172358; HM172359; HM172360; HM172361; HM172362; HM172363; HM172365; HM172366; HM172367; HM172368; HM172369; HM172370; HM172371; HM172372; HM172373; HM172374; HM172375; HM172376;… (truncated, 85750 characters total — see the official FDA record for the full value)
Recalling firm:
Verathon, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2021

Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478

Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

ALL 50 STATES
Full report

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

Recall #:
88431
Lot/product code:
All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.
Recalling firm:
Siemens Healthcare Diagnostics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2021

Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236

Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

ALL 50 STATES
Full report

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

Recall #:
88431
Lot/product code:
All lots impacted Kit lot numbers: 41331255 & 74682255 expiration date 2021-08-03, Lot number: 91605257 expiration date 2021-11-10.
Recalling firm:
Siemens Healthcare Diagnostics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2021

Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477

Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

ALL 50 STATES
Full report

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

Recall #:
88431
Lot/product code:
All lots impacted Kit lot numbers: 48553255 & 78009255 expiration date 2021-08-03, Lot number: 90311257 expiration date 2021-11-10.
Recalling firm:
Siemens Healthcare Diagnostics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 8, 2021

Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.

Full report

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

Recall #:
88109
Lot/product code:
Model 6000 Material Number/Product Description: 266002-1173-109/SD-OCT 6000 NEW CM ENH1 Serial Numbers: 6000-10007; 6000-10008; 6000-10010; 6000-10011; 6000-10012; 6000-10015; 6000-10016; 6000-10017; 6000-10020; 6000-10021; 6000-10022; 6000-10023; 6000-10024; 6000-10025; 6000-10026; 6000-10029; 6000-10031; 6000-10032; 6000-10034; 6000-10038; 6000-10039; 6000-10041; 6000-10043; 6000-10045; 6000-10047; 6000-10048; 6000-10049; 6000-10050; 6000-10051; 6000-10052; 6000-10053; 6000-10054; 6000-10056; 6000-10057; 6000-10058; 6000-10059; 6000-10060; 6000-10061; 6000-10062; 6000-10063; 6000-10064; 6000-10065; 6000-10066; 6000-10067; 6000-10068; 6000-10070; 6000-10071; 6000-10073; 6000-10074; 6000-10075; 6000-10076; 6000-10077; 6000-10078; 6000-10079; 6000-10080; 6000-10081; 6000-10082; 6000-10084; 6000-10085; 6000-10086; 6000-10087; 6000-10088; 6000-10089; 6000-10091; 6000-10092; 6000-10093; 6000-10095; 6000-10096; 6000-10097; 6000-10098; 6000-10100; 6000-10101; 6000-10103; 6000-10104; 6000-10105; 6000-10106; 6000-10107; 6000-10108; 6000-10110; 6000-10111; 6000-10114; 6000-10116; 6000-10117; 6000-10118; 6000-10119; 6000-10120; 6000-10121; 6000-10122; 6000-10124; 6000-10126; 6000-10128; 6000-10129; 6000-10130; 6000-10131; 6000-10132; 6000-10133; 6000-10134; 6000-10135; 6000-10136; 6000-10137; 6000-10138; 6000-10141; 6000-10142; 6000-10143; 6000-10144; 6000-10145; 6000-10146; 6000-10147; 6000-10148; 6000-10149; 6000-10150; 6000-10151; 6000-10152; 6000-10153; 6000-10155; 6000-10157; 6000-10158; 6000-10159; 6000-10160; 6000-10161; 6000-10162; 6000-10163; 6000-10164; 6000-10165; 6000-10166; 6000-10167; 6000-10168; 6000-10170; 6000-10171; 6000-10172; 6000-10173; 6000-10174; 6000-10175; 6000-10176; 6000-10177; 6000-10178; 6000-10179; 6000-10180; 6000-10181; 6000-10182; 6000-10183; 6000-10184; 6000-10185; 6000-10187; 6000-10188; 6000-10189; 6000-10190; 6000-10191; 6000-10192; 6000-10193; 6000-10194; 6000-10195; 6000-10196; 6000-10198; 6000-10199; 6000-10200; 6000-10201; 6000-10202; 6000-10203; 6000-10204; 6000-10205; 6000-10206; 6000-10207; 6000-10208; 6000-10209; 6000-10210; 6000-10211; 6000-10212; 6000-10213; 6000-10214; 6000-10215; 6000-10216; 6000-10217; 6000-10218; 6000-10219; 6000-10220; 6000-10221; 6000-10223; 6000-10224; 6000-10225; 6000-10226; 6000-10227; 6000-10229; 6000-10231; 6000-10233; 6000-10234; 6000-10236; 6000-10242; 6000-10243; 6000-10244; 6000-10245; 6000-10246; 6000-10248; 6000-10249; 6000-10250; 6000-10251; 6000-10252; 6000-10253; 6000-10254; 6000-10255; 6000-10256; 6000-10257; 6000-10259; 6000-10262; 6000-10265; 6000-10267; 6000-10268; 6000-10269; 6000-10270; 6000-10271; 6000-10272; 6000-10273; 6000-10274; 6000-10275; 6000-10276; 6000-10278; 6000-10279; 6000-10280; 6000-10281; 6000-10283; 6000-10285; 6000-10286; 6000-10289; 6000-10290; 6000-10292; 6000-10293; 6000-10294; 6000-10297; 6000-10298; 6000-10299; 6000-10300; 6000-10301; 6000-10304; 6000-10305; 6000-10306; 6000-10307; 6000-10308; 6000-10309; 6000-10315; 6000-10316; 6000-10318; 6000-10319; 6000-10322; 6000-10336; 6000-10340; 6000-10341; 6000-10343; 6000-10346; 6000-10353; 6000-10355; 6000-10363; 6000-10370; 6000-10379; 6000-10380; 6000-10387; 6000-10389; 6000-10392; 6000-10395; 6000-10396; 6000-10404; 6000-10405; 6000-10406; 6000-10407; 6000-10409; 6000-10410; 6000-10411; 6000-10417; 6000-10421; 6000-10425; 6000-10426; 6000-10429; 6000-10433; 6000-10436; 6000-10445; 6000-10448; 6000-10450; 6000-10452; 6000-10453; 6000-10454; 6000-10458; 6000-10467; 6000-10468; 6000-10470; 6000-10473; 6000-10475; 6000-10477; 6000-10478; 6000-10486; 6000-10489; 6000-10492; 6000-10498; 6000-10499; 6000-10500; 6000-10501; 6000-10502; 6000-10503; 6000-10504; 6000-10505; 6000-10506; 6000-10511; 6000-10512; 6000-10513; 6000-10514; 6000-10518; 6000-10519; 6000-10520; 6000-10523; 6000-10526; 6000-10527; 6000-10529; 6000-10532; 6000-10536; 6000-10537; 6000-10538; 6000-10546; 6000-10548; 6000-10557; 6000-10572; 6000-10582; 6000-10584; 6000-10586; 6000-10587; 6000-10589; 6000-10590; 6000-10592; 6000-10593; 6000-10596; 6000-10599; 6000-10603; 6000-10604; 6000-10605; 6000-10606; 6000-10607; 6000-10609; 6000-10610; 6000-10611; 6000-10612; 6000-10613; 6000-10616; 6000-10617; 6000-10620; 6000-10622; 6000-10627; 6000-10628; 6000-10629; 6000-10631; 6000-10632; 6000-10637; 6000-10639; 6000-10640; 6000-10644; 6000-10645; 6000-10646; 6000-10648; 6000-10649; 6000-10650; 6000-10653; 6000-10654; 6000-10657; 6000-10668; 6000-10669; 6000-10672; 6000-10673; 6000-10674; 6000-10675; 6000-10680; 6000-10681; 6000-10683; 6000-10687; 6000-10689; 6000-10696; 6000-10697; 6000-10698; 6000-10700; 6000-10702; 6000-10703; 6000-10704; 6000-10705; 6000-10708; 6000-10710; 6000-10711; 6000-10714; 6000-10722; 6000-10723; 6000-10724; 6000-10727; 6000-10728; 6000-10730; 6000-10731; 6000-10733; 6000-10734; 6000-10735; 6000-10736; 6000-10737; 6000-10738; 6000-10741; 6000-10743; 6000-10745; 6000-10746; 6000-10749; 6000-10751; 6000-10752; 6000-10755; 6000-10756; 6000-10757; 6000-10758; 6000-10759; 6000-10760; … (truncated, 11179 characters total — see the official FDA record for the full value)
Recalling firm:
Carl Zeiss Meditec, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 8, 2021

Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

ALL 50 STATES
Full report

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

Recall #:
88520
Lot/product code:
Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Recalling firm:
Argon Medical Devices, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 9, 2021

Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290

Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.

ALL 50 STATES
Full report

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

Recall #:
88272
Lot/product code:
a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 9, 2021

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Not guaranteed to be germ-free

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-0692-2021
Lot/product code:
Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021
Recalling firm:
Innoveix Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 9, 2021

Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Not guaranteed to be germ-free

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-0693-2021
Lot/product code:
Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022.
Recalling firm:
Innoveix Pharmaceuticals Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 9, 2021

CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

ALL 50 STATES
Full report

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

Recall #:
88308
Lot/product code:
All Lots
Recalling firm:
Ortho8, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 9, 2021

AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

ALL 50 STATES
Full report

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

Recall #:
88337
Lot/product code:
Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527
Recalling firm:
PROCEPT BIOROBOTICS CORPORATION
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 9, 2021

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

ALL 50 STATES
Full report

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

Recall #:
88308
Lot/product code:
All Lots
Recalling firm:
Ortho8, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 12, 2021

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

ALL 50 STATES
Full report

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

Recall #:
88324
Lot/product code:
Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330
Recalling firm:
Abbott Laboratories, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 12, 2021

Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.

ALL 50 STATES
Full report

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

Recall #:
88331
Lot/product code:
Serial Numbers between 22982051 - 23516741
Recalling firm:
W. L. Gore & Associates Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 14, 2021

Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com.

Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0749-2021
Lot/product code:
Best By Date: 9/2021
Recalling firm:
Qikmoov LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2021

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7

CGMP Deviations

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-0847-2021
Lot/product code:
All lots within expiry
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2021

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6

CGMP Deviations

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-0839-2021
Lot/product code:
All lots within expiry.
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2021

Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%) aerosol can, NET WT. 5.0 OZ (141 g) Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10143 7

CGMP Deviations

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-0840-2021
Lot/product code:
All lots within expiry.
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugChemicalRecalled July 14, 2021

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6

Chemical Contamination: presence of benzene

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0845-2021
Lot/product code:
06320E26, exp 1/2023
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2021

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4

CGMP Deviations

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-0841-2021
Lot/product code:
All lots within expiry.
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)