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Recalls affecting Nevada

Data last updated: September 8, 2026 at 1:13 PM UTC

16,567 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 May 23, 2018

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.

ALL 50 STATES
Full report

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

Recall #:
80769
Lot/product code:
00868579000209
Recalling firm:
Ortho Kinematics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 25, 2018

GE Healthcare CARESCAPE Monitor B650

When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

ALL 50 STATES
Full report

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

Recall #:
80262
Lot/product code:
Serial Numbers:  SEW13497373HA SEW13497374HA SEW13497375HA SEW13497376HA SEW13508068HA SEW12494591HA SEW14280294HA SEW14280298HA SEW14289769HA SEW14289777HA SK416341018HA SK416341019HA SK416341026HA SEW12494422HA SEW12494425HA SEW12494435HA SEW12494584HA SEW12494585HA SEW12494592HA SEW12494593HA SEW12494596HA SEW12494598HA SEW12494619HA SEW12494621HA SEW12494622HA SEW12494625HA SEW12494626HA SEW12504918HA SEW12504923HA SEW12504940HA SEW12504942HA SEW12504944HA SEW12504954HA SEW14278996HA SEW14279002HA SEW14279003HA SEW14279005HA SK416061047HA SK416061048HA SK416061088HA SK416081102HA SK416461063HA SK416461092HA SEW13109786HA SEW12059577HA SEW12059583HA SEW12059587HA SEW12059589HA SEW12059592HA SEW12059593HA SEW12059594HA SEW12059596HA SEW12059597HA SEW12059598HA SEW12059599HA SEW12059601HA SEW13275956HA SEW13276028HA SEW13276029HA SEW13275967HA SEW13276066HA SEW13276073HA SEW13286164HA SEW13286175HA SEW13286183HA SK415491246HA SK415491249HA SK415491253HA SK415491257HA SK415491259HA SK415491264HA SK415491265HA SQC17490035HA SQC17490038HA SQC17490039HA SQC17490040HA SQC17490042HA SEW15134264HA SEW15134269HA SEW15134270HA SK415211108HA SK415211110HA SK415211116HA SK415221002HA SK415221006HA SK415361118HA SK415361119HA SK415361120HA SK415361121HA SK415361122HA SK415361123HA SK416041059HA SK416051085HA SK416051119HA SK416041053HA SK416041054HA SK416041062HA SK416041063HA SK416041065HA SK415491254HA SK415521029HA SK415531048HA SK416011088HA SK416011113HA SK416501112HA SK416501119HA SK416501122HA SK417051035HA SK417051036HA SK417051038HA SK417051099HA SK417051100HA SK417051118HA SK417051121HA SK417051122HA SK417051125HA SK417051126HA SK417051130HA SK417051131HA SK417051139HA SK417051144HA SK417051145HA SK417051149HA SK417051150HA SK417051151HA SK417051152HA SK417051153HA SK417051154HA SK417051157HA SK417061002HA SK417061023HA SK417061024HA SK417061025HA SEW13508579HA SEW13369186HA SEW13369234HA SEW13369245HA SEW13369246HA SEW13369249HA SEW13369251HA SEW13369252HA SEW13369254HA SEW13369255HA SEW13369256HA SEW14381680HA SEW15166221HA SEW15166222HA SEW15166223HA SEW15166224HA SEW15166226HA SEW15166230HA SEW15166231HA SEW15166235HA SEW15166236HA SEW15166237HA SEW14063178HA SEW14062864HA SEW14062865HA SEW14062927HA SEW14063174HA SEW14063175HA SEW14063176HA SEW14063179HA SEW14062866HA SEW14235956HA SEW14235957HA SEW14235958HA SEW14235993HA SEW14235994HA SEW14235995HA SEW14246223HA SK416051106HA SK416051113HA SK416051114HA SK416051115HA SEW11202291HA SK416121077HA SK416121083HA SEW12245068HA SEW12245071HA SEW12245072HA SEW12245074HA SEW12245075HA SEW12245076HA SEW12482932HA SQC18150040HA SQC18150042HA SK416321071HA SK416321073HA SK416321075HA SK416321076HA SEW13317664HA SQC17500211HA SQC17500212HA SQC17500213HA SQC17500214HA SQC17500215HA SQC17500216HA SQC17500217HA SQC17500218HA SQC17500219HA SQC17500220HA SQC17500221HA SQC17500222HA SQC17500224HA SQC17500225HA SQC17500226HA SQC17500228HA SQC17500230HA SQC17500234HA SQC17500235HA SEW14063243HA SQC18010001HA SK417081005HA SEW13369260HA SEW13369277HA SEW13379768HA SEW13379778HA SEW13379779HA SEW13379780HA SEW13379782HA SEW13379784HA SEW13379790HA SEW13379791HA SEW14031040HA SEW14031041HA SEW14031042HA SEW14031044HA SEW14031045HA SEW14031046HA SEW14031047HA SEW14031060HA SEW14031061HA SEW14031062HA SEW14031066HA SEW14041261HA SEW14041262HA SEW14041263HA SEW14041264HA SEW14041267HA SEW14041268HA SEW14041269HA SEW14041271HA SEW14041282HA SEW14041283HA SEW14041284HA SEW14041286HA SEW14041287HA SEW14041289HA SEW14041290HA SEW14041291HA SEW14063210HA SEW14105484HA SEW14105968HA SEW14105969HA SEW14116795HA SEW14127301HA SEW14127307HA SEW14127308HA SEW14127312HA SEW14127313HA SEW14127314HA SEW14127315HA SEW14127316HA SEW14127317HA SEW14127318HA SEW14127319HA SEW14127320HA SEW14127321HA SEW14127322HA SEW14127323HA SEW14127324HA SEW14127325HA SEW14127326HA SEW14127327HA SEW14127328HA SEW14127329HA SEW14127330HA SEW14127331HA SEW14127332HA SEW14127333HA SEW14127334HA SEW14127335HA SEW14127631HA SEW14127632HA SEW14127633HA SEW14127634HA SEW14127635HA SEW14127636HA SEW14127637HA SEW14127638HA SEW14127639HA SEW14127863HA SEW14127864HA SEW14127865HA SEW14127866HA SEW14127867HA SEW13379789HA SEW13379793HA SQC17450282HA SQC17450283HA SQC17450284HA SQC17450285HA SQC17450287HA SQC17450289HA SQC17450292HA SQC17450293HA SEW12388960HA SEW12388971HA SEW12389025HA SEW12389026HA SEW12494289HA SEW12494291HA SEW12494292HA SEW12494293HA SEW12494294HA SEW12494296HA SEW12494316HA SEW12494319HA SEW12494320HA SEW12494321HA SEW12494323HA SEW12494324HA SEW12494325HA SEW12494328HA SEW12494559HA SEW12494561HA SEW12494562HA SEW12494568HA SEW12494603HA SEW12494605HA SEW12494606HA SEW12494607HA SEW12494608HA SEW12494610HA SEW12494611HA SEW12494612HA SEW12494613HA SEW12494615HA SEW13265672HA SEW13265673HA SEW13265674HA SEW13275965HA SK416071199HA SK416071202HA SK416071205HA SK416071206HA SK416071207HA SK416071208HA SK416071209HA SK416071210HA SK416071211HA SK416071212HA SK416071213HA SK416071214HA SK416071225HA… (truncated, 969250 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare Finland Oy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 30, 2018

FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."

Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.

ALL 50 STATES
Full report

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

Recall #:
80757
Lot/product code:
Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 30, 2018

Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.

When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.

Full report

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

Recall #:
81026
Lot/product code:
MODEL SERIAL NUMBER SID MEXL-1504/U4 U4A12Z2020 30005914 MEXL-1504/T4 S4D1132069 339325 MEXL-1504/S4 S4A1032017 326165 MEXL-1504/U4 U4A1312023 30000547 MEXL-1504/S4 S4A1032019 327601 MEXL-1504/U4 U4A1312024 30002325 MEXL-1504/T4 S4D1152082 330035 MEXL-1504/S4 S4A1082040 330134 MEXL-1504/A4 A4A11Z2011 346866 MEXL-1504/U4 U4A1282003 356105 MEXL-1504/U4 U4A1322025 30009003 MEXL-1504/U4 U4B1442070 30012516 MEXL-1504/U4 U4A1352035 389636 MEXL-1504/U4 U4B1552097 30010318 MEXL-1504/U4 U4A12X2010 351817 MEXL-1504/S4 S4C1112065 330381 MEXL-1504/S4 S4C1112064 334599 MEXL-1504/A4 A4A11Z2009 352039 MEXL-1504/S4.004 S4A1072033 30025756 MEXL-1504/S4 S4A09Y2002 345231 MEXL-1504/U4.004 U4A1282002 30027784 MEXL-1504/U4.004 U4A1382047 30036224 MEXL-1504/S3 S3A0972030 312421 MEXL-1504/U4 U4A12X2011 345074 MEXL-1504/S4 S4C1112061 337212 MEXL-1504/U4 U4A13X2054 30011038 MEXL-1504/A4 A4A1222015 351023 MEXL-1504/U4 U4A1322026 337071 MEXL-1504/U4 U4B1642106 30008395 MEXL-1504/A4 A4A1222017 347963 MEXL-1504/S4 S4A10X2047 315713 MEXL-1504/S3 S3A08Z2019 303586 MEXL-1504/U4 U4B1522092 358163 MEXL-1504/A4 A4A11X2004 30018147 MEXL-1504/T4 S4D1132074 347260 MEXL-1504/U4 U4B1422064 30021502 MEXL-1504/U4 U4A1312022 30004266 MEXL-1504/U4 U4A1352036 30001882 MEXL-1504/U4 U4A1372046 337083 MEXL-1504/T4 S4D1142076 341529 MEXL-1504/U4 U4A13Z2057 30005810 MEXL-1504/A4 A4A11Z2010 349167 MEXL-1504/U4 U4A1292007 349175 MEXL-1504/U4 U4B1632105 366015 MEXL-1504/U4 U4B1492081 376523 MEXL-1504/U4 U4A1352037 389696 MEXL-1504/U4 U4A1312021 353532 MEXL-1504/U4 U4B1482077 392326 MEXL-1504/A4 A4A11X2002 333633 MEXL-1504/U4 U4B14Y2082 30018555 MEXL-1504/U4 U4A13X2051 325434 MEXL-1504/A4 A4A11Y2006 350868 MEXL-1504/A4 A4A1252024 356295 MEXL-1504/U4 U4B1532094 30027785 MEXL-1504/U4 U4B1652107 30009792 MEXL-1504/S3 S3A0922023 299545 MEXL-1504/U4 U4A1382049 30007016 MEXL-1504/U4 U4A12Z2014 356808 MEXL-1504/S3 S3A0892009 301747 MEXL-1504/A4 A4A11X2003 324905 MEXL-1504/S3.004 S3A0882007 30024991 MEXL-1504/T4 S4D1132073 339838 MEXL-1504/U4 U4A1362039 393723 MEXL-1504/U4 U4B1462074 356287 MEXL-1504/U4 U4B1522091 30006245 MEXL-1504/U4 U4A1342033 30004737 MEXL-1504/U4 U4A1342034 30001465 MEXL-1504/U4 U4A12X2009 354860 MEXL-1504/U4 U4A1412059 383292 MEXL-1504/U4 U4A1412063 30003291 MEXL-1504/U4 U4A1282004 356881 MEXL-1504/U4 U4A1352038 30004544 MEXL-1504/U4 U4A12Y2013 359834 MEXL-1504/U4 U4B14Z2086 30023668 MEXL-1504/U4 U1A13Z2001 30007654 MEXL-1504/S3 S3A0942027 314575 MEXL-1504/U4 U4A1272001 357343 MEXL-1504/U4 U4A1292006 384206 MEXL-1504/S4 S4A1042023 308445 MEXL-1504/S3 S3A08Z2016 308437 MEXL-1504/A4 A4A11X2001 342766 MEXL-1504/U4 U4B1512089 30006322 MEXL-1504/A4 A4A1212012 352641 MEXL-1504/U4 U4A1342029 314591 MEXL-1504/T4 S4E1192095 340919 MEXL-1504/U4 U4A1362041 30004910 MEXL-1504/U4 U4A12Y2012 356816 MEXL-1504/U4 U4A1382050 30006997 MEXL-1504/A4 A4A1242021 345363 MEXL-1504/S4 S4A1092046 333104 MEXL-1504/A4 A4A1252023 348078 MEXL-1504/U4 U4B15Y2102 30002102 MEXL-1504/U5 U5B15Z2001 30002103 MEXL-1504/T4 S4D1132071 328690 MEXL-1504/U4 U4A13Y2056 30004937 MEXL-1504/S4 S4A1092043 310631 MEXL-1504/U4 U4A1322027 394526 MEXL-1504/U4 U4B1522093 30007522 MEXL-1504/U4 U4A1412061 389344 MEXL-1504/S3 S3A0872005 298422 MEXL-1504/U4 U4A12Z2017 357400 MEXL-1504/A4 A4A1212013 349118 MEXL-1504/U4 U4B1482076 30020797 MEXL-1504/U4 U4B1552098 30012104 MEXL-1504/A4 A4A1222019 352146 MEXL-1504/S4 S4A1052025 324327 MEXL-1504/U4 U4A1292008 356568 MEXL-1504/A4 A4A1222016 340950 MEXL-1504/U4 U4B1432067 30007279 MEXL-1504/U4 U4A1362042 357418 MEXL-1504/S4 S4A1092045 333047 MEXL-1504/U4 U4B1452071 30009112 MEXL-1504/A4 A4A1242022 351429 MEXL-1504/A4 A4A1262025 394677 MEXL-1504/S4 S4A1082036 331306 MEXL-1504/S4 S4C1112060 340539 MEXL-1504/T4 S4D1152081 342436 MEXL-1504/S4 S4A09X2001 317842 MEXL-1504/U4 U4A12Z2019 356063 MEXL-1504/T4.004 S4D1142079 372281 MEXL-1504/U4 U4B1512090 30011831 MEXL-1504/U4 U4A13X2055 372615 MEXL-1504/U4 U4A1362044 30008519 MEXL-1504/A4 A4A11X2005 343723 MEXL-1504/U4 U4B15X2101 30008684 MEXL-1504/S4 S4A1072032 316471 MEXL-1504/U4 U4B1482079 377483 MEXL-1504/U4 U4B1582100 30004842 MEXL-1504/S4 S4A1022013 313254 MEXL-1504/S4 S4A1022014 313262 MEXL-1504/U4 U4B1612103 30029397 MEXL-1504/T4 S4D1132070 337303 MEXL-1504/U4 U4A1382048 30003156 MEXL-1504/U4 U4B1612104 385256 MEXL-1504/T4 S4E1182093 342311 MEXL-1504/U4 U4A13X2052 380285 MEXL-1504/U4 U4A12Z2015 356840 MEXL-1504/U4 U4B1452072 369092 MEXL-1504/U4 U4B1452073 30007850 MEXL-1504/U4 U4B1582099 30006070 MEXL-1504/S4 S4A1022015 326512 MEXL-1504/U4 U4B14Y2084 365309 MEXL-1504/S3 S3A08Y2013 292490 MEXL-1504/S4 S4B10Z2058 336701 MEXL-1504/S3 S3A09X2039 351542 MEXL-1504/S4 S4A1092044 308189 MEXL-1504/A4 A4A1222018 345587 MEXL-1504/A4.007 A4A1222014 392554 MEXL-1504/T4 S4D1172089 345140 MEXL-1504/U4 U4B1432066 30008575 MEXL-1504/U4 U4B1442069 30007942 MEXL-1504/S4 S4A1082041 329656 MEXL-1504/S3 S3A09X2041 311514 MEXL-1504/A4 A4A11Y2008 348169 MEXL-1504/S3 S3A08Y2012 311506 MEXL-1504/S4 S4A1062030 311522 … (truncated, 8057 characters total — see the official FDA record for the full value)
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2018

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

ALL 50 STATES
Full report

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

Recall #:
81073
Lot/product code:
Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
FoodRecalled June 11, 2018

Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bottle Supplement Facts Serving Size:***Vitamin B-12 (as Methylcobalamyn) ABSONUTRIX 5500 Adams Farm Lane, Suite 206 Greensboro NC 27407 UPC 7 00443 88822 6

The firm was informed that the product did not contain vitamin B12 (Methylcobalamyn) as listed on the label.

Full report

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

Recall #:
F-1592-2018
Lot/product code:
Lot #:160318-2 Exp: 03/2019, Lot# ASM4192017 Exp: 04-2020
Recalling firm:
Absonutrix
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 11, 2018

Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

Device could not meet the requirements for systolic pressure

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Full report

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

Recall #:
80533
Lot/product code:
7024260310
Recalling firm:
Withings Sas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2018

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

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Full report

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

Recall #:
89584
Lot/product code:
All device serial numbers. Material Numbers 1040001 1054096 1054097 1054260 1054655 1058180 1119867 1040001B 1054096B 1054096NB 1054097B 1054260B 1054655B 1054655TP 1054655TPV 1058180B AU1054096 AU1054096B BR1054096 BT1054096 BT1054260 CA1054096 CA1054096B CN1054096 IT1054096B KO1054096 KR1054096 LA1054096 LG1054096 R1054096 R1054096B R1054097 R1054097B R1054260 R1054260B R1054655 R1054655B R1054655TP R1054655TPV R1119867 RSL1054260 RSL1054260B RTO1054260 RTO1054260B U1054096 U1054096B U1054097 U1054097B U1054260 U1054260B U1054655 RBR1054096 RTO1119867 1032800 1032802 1032804 1040002 1040005 1032800B 1032802B 1032804B 1032804TP 1032804TPV 1040002B 1040005B 1125564B AU1032800 AU1032800B BR1032800 CA1032800 CA1032800B IT1032800B KO1032800 KR1032800 LA1032800 LG1032800 R1032800 R1032802 R1032804 R1032804B R1032804TP R1032804TPV R1040005 R1040005B RTO1040005B SP1032800B U1032800 U1032802 U1032804 U1040005 U1040005B
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 13, 2018

JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

ALL 50 STATES
Full report

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

Recall #:
80313
Lot/product code:
All lots
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 13, 2018

JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

ALL 50 STATES
Full report

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

Recall #:
80313
Lot/product code:
All lots
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 13, 2018

Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229

The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

ALL 50 STATES
Full report

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

Recall #:
80313
Lot/product code:
All lots
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 20, 2018

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

Full report

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

Recall #:
80501
Lot/product code:
All Maestro 4000 Generators used with the optional foot switch.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2018

POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.

Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.

ALL 50 STATES
Full report

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

Recall #:
82513
Lot/product code:
REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2018

Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

ALL 50 STATES
Full report

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

Recall #:
82662
Lot/product code:
Software Version 11.1
Recalling firm:
Elekta Instrument AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2018

Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.

Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

ALL 50 STATES
Full report

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

Recall #:
85403
Lot/product code:
Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
Recalling firm:
Genicon, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2018

PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

Incorrect expiration being entered for one lot.

ALL 50 STATES
Full report

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

Recall #:
82015
Lot/product code:
Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
Recalling firm:
Abbott Vascular
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 5, 2018

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

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-0925-2018
Lot/product code:
Lot #: 7F021B, Exp 6/30/20
Recalling firm:
Sanofi-Aventis U.S. LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 12, 2018

VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

ALL 50 STATES
Full report

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

Recall #:
80717
Lot/product code:
2470 2480 2490 2501 2510 2521
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 12, 2018

Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

ALL 50 STATES
Full report

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

Recall #:
81922
Lot/product code:
SmartStep Option
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 12, 2018

VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

ALL 50 STATES
Full report

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

Recall #:
80717
Lot/product code:
5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 12, 2018

VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

ALL 50 STATES
Full report

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

Recall #:
80717
Lot/product code:
2470 2480 2490 2500 2510 2520 2530
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 12, 2018

VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

ALL 50 STATES
Full report

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

Recall #:
80717
Lot/product code:
2330 2340 2350 2360 2370 2380
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-0975-2018
Lot/product code:
All lots within expiry.
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-0973-2018
Lot/product code:
All lots within expiry.
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2018

Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple physiological parameters in healthcare environments for the patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

ALL 50 STATES
Full report

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

Recall #:
80645
Lot/product code:
UDI# VS4 (863283): 00884838087095
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)