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Recalls affecting Nebraska

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

16,537 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 February 3, 2022

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

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

Full report

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

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

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

Elevated levels of lead

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 #:
F-0824-2022
Lot/product code:
The product has no manufacturing code and no expiration date.
Recalling firm:
A & E Corrales LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 3, 2022

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

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

ALL 50 STATES
Full report

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

Recall #:
89604
Lot/product code:
Serial numbers AS1001 through AS1387 UDIs: (01)00380740138479(21)AS1002 (01)00380740138479(21)AS1005 (01)00380740138479(21)AS1009 (01)00380740138479(21)AS1012 (01)00380740138479(21)AS1013 (01)00380740138479(21)AS1016 (01)00380740138479(21)AS1019 (01)00380740138479(21)AS1023 (01)00380740138479(21)AS1028 (01)00380740138479(21)AS1031 (01)00380740138479(21)AS1032 (01)00380740138479(21)AS1044 (01)00380740138479(21)AS1058 (01)00380740138479(21)AS1064 (01)00380740138479(21)AS1097 (01)00380740138479(21)AS1126 (01)00380740138479(21)AS1148 (01)00380740138479(21)AS1153 (01)00380740138479(21)AS1155 (01)00380740138479(21)AS1160 (01)00380740138479(21)AS1161 (01)00380740138479(21)AS1193 (01)00380740138479(21)AS1212 (01)00380740138479(21)AS1213 (01)00380740138479(21)AS1215 (01)00380740138479(21)AS1217 (01)00380740138479(21)AS1218 (01)00380740138479(21)AS1219 (01)00380740138479(21)AS1220 (01)00380740138479(21)AS1221 (01)00380740138479(21)AS1222 (01)00380740138479(21)AS1224 (01)00380740138479(21)AS1225 (01)00380740138479(21)AS1226 (01)00380740138479(21)AS1227 (01)00380740138479(21)AS1230 (01)00380740138479(21)AS1231 (01)00380740138479(21)AS1233 (01)00380740138479(21)AS1234 (01)00380740138479(21)AS1235 (01)00380740138479(21)AS1236 (01)00380740138479(21)AS1237 (01)00380740138479(21)AS1238 (01)00380740138479(21)AS1240 (01)00380740138479(21)AS1241 (01)00380740138479(21)AS1242 (01)00380740138479(21)AS1243 (01)00380740138479(21)AS1246 (01)00380740138479(21)AS1247 (01)00380740138479(21)AS1248 (01)00380740138479(21)AS1249 (01)00380740138479(21)AS1250 (01)00380740138479(21)AS1251 (01)00380740138479(21)AS1252 (01)00380740138479(21)AS1253 (01)00380740138479(21)AS1254 (01)00380740138479(21)AS1255 (01)00380740138479(21)AS1256 (01)00380740138479(21)AS1257 (01)00380740138479(21)AS1259 (01)00380740138479(21)AS1261 (01)00380740138479(21)AS1262 (01)00380740138479(21)AS1263 (01)00380740138479(21)AS1264 (01)00380740138479(21)AS1266 (01)00380740138479(21)AS1267 (01)00380740138479(21)AS1268 (01)00380740138479(21)AS1269 (01)00380740138479(21)AS1270 (01)00380740138479(21)AS1271 (01)00380740138479(21)AS1272 (01)00380740138479(21)AS1273 (01)00380740138479(21)AS1274 (01)00380740138479(21)AS1275 (01)00380740138479(21)AS1276 (01)00380740138479(21)AS1277 (01)00380740138479(21)AS1278 (01)00380740138479(21)AS1279 (01)00380740138479(21)AS1280 (01)00380740138479(21)AS1281 (01)00380740138479(21)AS1282 (01)00380740138479(21)AS1283 (01)00380740138479(21)AS1284 (01)00380740138479(21)AS1285 (01)00380740138479(21)AS1286 (01)00380740138479(21)AS1287 (01)00380740138479(21)AS1288 (01)00380740138479(21)AS1289 (01)00380740138479(21)AS1290 (01)00380740138479(21)AS1291 (01)00380740138479(21)AS1293 (01)00380740138479(21)AS1294 (01)00380740138479(21)AS1295 (01)00380740138479(21)AS1296 (01)00380740138479(21)AS1299 (01)00380740138479(21)AS1300 (01)00380740138479(21)AS1301 (01)00380740138479(21)AS1302 (01)00380740138479(21)AS1303 (01)00380740138479(21)AS1304 (01)00380740138479(21)AS1305 (01)00380740138479(21)AS1306 (01)00380740138479(21)AS1307 (01)00380740138479(21)AS1309 (01)00380740138479(21)AS1310 (01)00380740138479(21)AS1311 (01)00380740138479(21)AS1312 (01)00380740138479(21)AS1313 (01)00380740138479(21)AS1314 (01)00380740138479(21)AS1315 (01)00380740138479(21)AS1316 (01)00380740138479(21)AS1317 (01)00380740138479(21)AS1318 (01)00380740138479(21)AS1319 (01)00380740138479(21)AS1320 (01)00380740138479(21)AS1321 (01)00380740138479(21)AS1322 (01)00380740138479(21)AS1323 (01)00380740138479(21)AS1325 (01)00380740138479(21)AS1326 (01)00380740138479(21)AS1327 (01)00380740138479(21)AS1330 (01)00380740138479(21)AS1332 (01)00380740138479(21)AS1333 (01)00380740138479(21)AS1334 (01)00380740138479(21)AS1336 (01)00380740138479(21)AS1341 (01)00380740138479(21)AS1344 (01)00380740138479(21)AS1346 (01)00380740138479(21)AS1347 (01)00380740138479(21)AS1348 (01)00380740138479(21)AS1349 (01)00380740138479(21)AS1350 (01)00380740138479(21)AS1351 (01)00380740138479(21)AS1352 (01)00380740138479(21)AS1353 (01)00380740138479(21)AS1354 (01)00380740138479(21)AS1355 (01)00380740138479(21)AS1358 (01)00380740138479(21)AS1359 (01)00380740138479(21)AS1360 (01)00380740138479(21)AS1368
Recalling firm:
Abbott Laboratories, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2022

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

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

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

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

Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

Labeling - product contains not listed on the label ethyl alcohol

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-0636-2022
Lot/product code:
Lot#:339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398 and 399
Recalling firm:
Tsm Brands LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugUndeclaredRecalled February 7, 2022

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

Labeling - product contains not listed on the label ethyl alcohol

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-0635-2022
Lot/product code:
Lot#: 39,40,41,42,43,44 and 45
Recalling firm:
Tsm Brands LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2022

BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

ALL 50 STATES
Full report

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

Recall #:
89684
Lot/product code:
Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
Recalling firm:
Bio-Rad Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 8, 2022

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

ALL 50 STATES
Full report

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

Recall #:
89684
Lot/product code:
Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262
Recalling firm:
Bio-Rad Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 9, 2022

Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

ALL 50 STATES
Full report

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

Recall #:
89740
Lot/product code:
UDI: 00630414287935; Lot Numbers: 110108 110185 110238 110302
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 9, 2022

Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

ALL 50 STATES
Full report

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

Recall #:
89740
Lot/product code:
UDI: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 9, 2022

Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

ALL 50 STATES
Full report

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

Recall #:
89740
Lot/product code:
UDI: 00630414595580; Lot Numbers: 211359 211451
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 9, 2022

Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

ALL 50 STATES
Full report

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

Recall #:
89740
Lot/product code:
UDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 9, 2022

Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.

ALL 50 STATES
Full report

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

Recall #:
89744
Lot/product code:
UDI# 00607567700901, Lots (3): 25153700, 25157489, 25158616. Please note affected lot numbers (25153700, 25157489, 25158616) appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number (200501), which is etched onto all 3 device components on side of handle and on underside above each pin.
Recalling firm:
Maquet Cardiovascular, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2022

CombiDiagnost R90 1.1 (709031)

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

ALL 50 STATES
Full report

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

Recall #:
93819
Lot/product code:
Model: R90 1.1 (709031); UDI DI: 00884838101456; Software version 1.1.1 or higher; Serial Numbers: 10001004, 10001005, 10001006, 10001008, 10001009, 10001010, 10001011, 10001012, 10001013, 10001018, 10001020, 10001022, 10001024, 10001026, 10001027, 10001028, 10001029, 10001030, 10001031, 10001032, 10001035, 10001036, 10001043, 10001044, 10001045, 10001046, 10001047, 10001048, 10001049, 10001050, 10001051, 10001052, 10001053, 10001054, 10001055, 10001056, 10001057, 10001058, 10001059, 10001060, 10001061, 10001062, 10001063, 10001064, 10001065, 10001066, 10001067, 10001068, 10001069, 10001070, 10001071, 10001072, 10001073, 10001074, 10001075, 10001076, 10001077, 10001078, 10001079, 10001080, 10001081, 10001083, 10001084, 10001085, 10001086, 10001087, 10001088, 10001089, 10001090, 10001091, 10001092, 10001093, 10001094, 10001095, 10001096, 10001097, 10001098, 10001099, 10001100, 10001101, 10001102, 10001103, 10001104, 10001105, 10001106, 10001107, 10001108, 10001109, 10001110, 10001111, 10001112, 10001113, 10001114, 10001115, 10001116, 10001117, 10001118, 10001119, 10001120, 10001121, 10001122, 10001123, 10001124, 10001125, 10001126, 10001127, 10001128, 10001129, 10001130, 10001131, 10001132, 10001133, 10001134, 10001135, 10001136, 10001137, 10001138, 10001139, 10001140, 10001141, 10001142, 10001143, 10001144, 10001145, 10001147, 10001148, 10001149, 10001150, 10001152, 10001201;
Recalling firm:
PHILIPS MEDICAL SYSTEMS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2022

RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7), RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6), RayStation/RayPlan 7 (7.0.0.19), RayStation/RayPlan 8A (8.0.0.61), RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) Software versions: 4.0.0.14, 4.0.3.4, 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, 10.1.1.54, 11.0.0.951, 11.0.1.29, 11.0.3.116 or 12.0.0.932

Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

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

Recall #:
89822
Lot/product code:
UDI # 07350002010020, 07350002010013, 07350002010082, 07350002010075, 07350002010242, 07350002010068, 07350002010112, 07350002010136, 07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010310, 07350002010471, 07350002010389, 07350002010433, 07350002010440, 07350002010426
Recalling firm:
RaySearch America Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled February 11, 2022

CombiDiagnost R90 1.0 (709030)

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

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

Recall #:
93819
Lot/product code:
Model: R90 1.0 (709030); UDI DI: 00884838076747; Software version 1.1.1 or higher; Serial numbers: 10000000, 10000002, 10000003, 10000004, 10000006, 10000011, 10000012, 10000020, 10000024, 10000027, 10000049, 10000050, 10000065, 10000066, 10000067, 10000069, 10000078, 10000081, 10000099, 10000103, 10000107, 10000140, 10000145, 10000152, 10000180, 10001001, 10001010, 10001095, 591362, SN16000009, SN17000003, SN17000007, SN17000015, SN17000022, SN17000111, SN17000114, SN17000118, SN17000120, SN17000121, SN17000122, SN17000123, SN17000128, SN17000129, SN17000130, SN17000145, SN17000146, SN17000147, SN17000148, SN17000153, SN17000157, SN17000163, SN17000165, SN17000166, SN18000003, SN18000004, SN18000010, SN18000021, SN18000025, SN18000033, SN18000037, SN18000038, SN18000044, SN18000045, SN18000053, SN18000054, SN18000057, SN18000060, SN18000068, SN18000069, SN18000079, SN19000004, SN19000006, SN19000011, SN19000020, SN19000034, SN19000036, 27, 40, 41, 42, 77, 101, 131, 155, 180, 190;
Recalling firm:
PHILIPS MEDICAL SYSTEMS
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UnclassifiedRisk not yet known
Medical deviceRecalled February 15, 2022

Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.

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

Recall #:
89666
Lot/product code:
UDI: 00840733102318 All units in the field, all serial numbers.
Recalling firm:
Meridian Bioscience Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 15, 2022

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

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

Recall #:
90129
Lot/product code:
Lot Number 101321021B
Recalling firm:
Luminex Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 16, 2022

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

IRISpec CA failures for glucose.

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

Recall #:
89655
Lot/product code:
Lot #583-21 and higher, UDI 10837461002611.
Recalling firm:
Beckman Coulter, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugChemicalRecalled February 16, 2022

Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA

Chemical contamination: Presence of benzene

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

Recall #:
D-0207-2024
Lot/product code:
All lots, expiry on or before August 2023
Recalling firm:
TCP HRB ACQUISITON LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugChemicalRecalled February 16, 2022

Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06

Chemical contamination: Presence of benzene

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Full report

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

Recall #:
D-0208-2024
Lot/product code:
All lots, expiry on or before August 2023
Recalling firm:
TCP HRB ACQUISITON LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugChemicalRecalled February 16, 2022

Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06

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-0209-2024
Lot/product code:
All lots, expiry on or before August 2023
Recalling firm:
TCP HRB ACQUISITON LLC
View official FDA record (opens in a new tab)