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Recalls affecting Utah

Data last updated: September 9, 2026 at 1:18 PM UTC

16,598 recalls found
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Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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 Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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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 Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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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 Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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 Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

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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

Martina — Mangoes

Potential contamination with Salmonella

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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 December 8, 2020

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

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

Recall #:
86988
Lot/product code:
Lot numbers: 0010258435, 0010281390, 0010312360, 0010353505, 0010384900, 0010273889, 0010281391, 0010312361, 0010353507, 0010384901, 0010273890, 0010281392, 0010312362, 0010369366, 0010384903, 0010273891, 0010289835, 0010316959, 0010369367, 0010393220, 0010273893, 0010289836, 0010316960, 0010376784, 0010393221, 0010278418, 0010297678, 0010316961, 0010376785, 0010278427, 0010305929, 0010316963, 0010376786, 0010281384, 0010305937, 0010336620, 0010384897
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

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

Recall #:
87322
Lot/product code:
Table CAT-880B Models: INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BHUP INFX-8000F/AH INFX-8000F/AH INFX-8000F/UU INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/AH INFX-8000F/BH  Table Serial Numbers: 99E1582258 99F18Y2428 99C1482200 99E15Y2271 99F1862406 99G19Z2438 99E1662308 99E1762365 99A1337005 99F1852401 99E1612286 99E1712347 99E1712345 99C14Z2224 99E1592262 99G1972436  System Serial Numbers: AHA1582003 AHC18Y2013 AHA1482001 AHA15Y2005 AHC1862012 BHB19Z2002 AHB1662007 AHB1762010 UUB12X2034 AHC1852011 AHA1612006 AHB1712009 AHB1712008 AHA14Z2002 AHA1592004 BHB1972001
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2020

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

ALL 50 STATES
▸Full report

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

Recall #:
87322
Lot/product code:
Table CAT-880B Models: INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/A8 INFX-8000V/U7 INFX-8000V/AA INFX-8000V/U7 INFX-8000V/UF INFX-8000V/BN INFX-8000V/BU INFX-8000V/UD INFX-8000V/UL INFX-8000V/A6 INFX-8000V/AC INFX-8000V/AA INFX-8000V/UU INFX-8000V/A6 INFX-8000V/U5 INFX-8000V/BAUP INFX-8000V/A2 INFX-8000V/A2 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/UL INFX-8000V/UL INFX-8000V/A4 INFX-8000V/BG INFX-8000V/BG INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/AA INFX-8000V/BQ INFX-8000V/UU INFX-8000V/BL INFX-8000V/BL INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/AC INFX-8000V/BL INFX-8000V/UF INFX-8000V/UF INFX-8000V/BY INFX-8000V/BS INFX-8000V/A6 INFX-8000V/AA INFX-8000V/AC INFX-8000V/UF INFX-8000V/UF INFX-8000V/B6 INFX-8000V/UF INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/U7 INFX-8000V/UU INFX-8000V/UD INFX-8000V/BC INFX-8000V/UU INFX-8000V/BG INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A4 INFX-8000V/UL INFX-8000V/A8/VL63-2015B/A INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/BY INFX-8000V/BY INFX-8000V/UF INFX-8000V/AA INFX-8000V/A8 INFX-8000V/A4 INFX-8000V/AA INFX-8000V/A6 INFX-8000V/B2 INFX-8000V/BU INFX-8000V/UU INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/A6 INFX-8000V/UU INFX-8000V/BQ  Table Serial Numbers: 99E15X2267 99E1692317 99C1472192 99E16Y2329 99A12X2107 99E1542248 99C1462190 99C1442183 B1B19Y2043 B1A1942008 99A1292104 99A1322127 99E15Y2275 99C1492204 99C1492205 99A12Z2117 99E1742358 99A1272094 B1C2012053 99F18X2427 99F1952435 99D1522239 99A12Z2118 99C1392151 99C1452189 99F1862408 B1B1962022 B1B1962021 99E1652304 99F1862407 99E17X2373 99E17X2374 99E17X2375 B1B1962023 99A12X2108 B1C2022054 B1B1992039 99E16X2328 99E1622292 99E16Y2338 B1A1952015 99A12X2109 99C1452184 B1B1992038 B1C2052064 99C14Z2230 99F1882417 99E1622293 99C13X2156 99C13X2155 B1C2072071 99B1362141 99F1862403 99H2032441 99E17Z2380 99A1322125 99C13Z2167 99A1322123 B1B19X2041 99A12X2106 B1C2072073 99E16Y2336 99E1612287 99C14X2207 99C1452185 99E17Z2382 99F1842398 99E1532243 99C14Z2232 B1A1932006 B1A1932004 99A12Z2116 99E1712346 99E17X2372 99C1512236 99C14X2206 99E1582261 B1B1962020 B1B1982033 99C1452186 99F1862402 99F1862405 99E16Z2340 99A1312120 B1C2082075  System Serial Numbers: A6A15X2003 AAA1692006 ACA1472001 A8B16Y2002 U7D12X2007 A9A1542001 U7E1462009 UFD1442017 BNB19Y2001 BUB1942001 UDA0952001 ULC1322012 A6A15Y2004 ACA1492002 AAA1492001 UUB12Z2009 A6B1742011 U5E1272003 BAD2012001 A2C18X2001 A2C1952002 A4A1522004 ULC1282010 ULD1392013 ULD1452016 A4B1862007 BGB1962002 BGB1962001 A6B1652007 AAB1862012 AAA17X2008 AAA17X2009 AAA17X2010 BQB1962001 UUB12X2008 BLD2022003 BLB1992002 A6B16X2008 A6B1622006 ACB16Y2004 BLB1952001 UFC12X2011 UFD1452018 BYB1992003 BSD2052001 A6A14Z2001 AAB1882013 ACB1622003 UFD13X2016 UFD13X2015 B6D2072001 UFD1362014 A6C1862014 A6C2032016 A6B17Z2012 U7D1322008 UUC13Z2011 UDD1322016 BCB19X2001 UUB12X2007 BGD2072003 A6B16Y2009 A6A1612005 A4A14X2001 ULD1452015 A8B17Z2004 AAB1842011 A8A1532001 A4A14Z2002 BYA1932002 BYA1932001 UFC12Z2013 AAA1712007 A8B17X2003 A4A1512003 AAA14X2002 A6A1582002 B2B1962001 BUB1982002 UUC1452012 A6C1862013 A6C1862015 A6B16Z2010 UUB1312010 BQD2082002
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

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

Recall #:
87023
Lot/product code:
Discovery NM 630 (Model Number H3101RH), Serial numbers: 63GY50110,  63GY50119, 63GY50116, 63GZ50141, 63GY50120, 63GY50108, 63GY50121, 63GZ50142, 63GY50112, 63GZ50139, 63GY50107, 63GZ50138   NM 830 (Model Number H3910AC), Serial Numbers: 830Z60199, 830Z60182, 830Z60183, 830Z60192, 830Y60089, 830Y60105, 830Y60079, 830Z60207, 830Y60092, 830Y60102, 830Y60081, 830Z60200, 830Y60106, 830Z60201, 83EZ88001, 830Y60111, 830Y60094, 830Z60211, 830Y60101, 830Z60210, 830Y60118, 830Z60195, 830Z60194, 830Z60198, 830Z60181, 830Z60202, 830Y60097, 830Z60196, 830Z60180, 830Y60078, 830Y60115, 830Y60114, 830Y60108, 830Y60100, 830Y60087, 830Y60084, 830Z60188, 830Z60206, 830Y60112, 830Y60082, 830Y60093, 830Z60191, 830Y60107, 830Y60080, 830Z60190, 830Y60103, 830Z60193, 830Y60095, 830Y60119, 830Z60209, 830Z60205, 830Y60073, 830Y60120, 830Y60083, 830Y60116, 830Z60203, 830Y60085, 830Y60077, 830Z60184, 830Y60086, 830Z60187, 830Y60113, 830Z60208, 830Y60110, 830Z60204, 830Y60072, 830Z60179, 830Z60186   830 NM Cyber Defense (Model Number H3910AG), Serial Numbers: 830Z60185
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

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

Recall #:
87023
Lot/product code:
Discovery 670 DR (Model H3100BT), Serial Numbers: DRGY56033, DRGY56037, DRGY56035, DRGY56030, DRGZ56043, DRGZ56042, DRGY56032, DRGY56031, DRGY56034, DRGY56036    NM/CT 870 DR (Model 3100Q), Serial Numbers: 870Y64066, and (Model H3100AS), Serial Numbers: 870Y64077, 870Y64064, 870Y64081, 870Y64079, 870Y64067, 870Y64074, 870Z64117, 870Y64078, 870Y64080, 870Y64069, 870Y64085, 870Z64121, 870Z64119, 870Z64122, 870Y64056, 870Y64063, 870Z64114, 870Z64115, 870Y64068, 870Y64082, 870Z64116, 870Z64120, 870Y64065, 870Y64084, 870Y64061, 870Y64083, 870Z64113, 870Y64070, 870Z64123, 870Y64058, 870Z64118, 870Y64057   Discovery NM670 Pro (Model 3100XB), Serial Numbers: PRGY52027,  PRGY52031, PRGZ52047, PRGZ52046, PRGY52028, PRGZ52048, PRGY52029, PRGY52030    Discovery 670 ES (Model H3100XF), Serial Numbers: ESGZ53005
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

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

Recall #:
87023
Lot/product code:
Serial numbers: 85EY67048, 850Y61018, 85EY67045, 85EY67046, 85EY67047, 850Z61038, 85EY67043, 850Z61042, 85EZ67056, 850Z61043,  850Z61044, 850Z61045, 850Z61041, 850Z61039, 850Z61040, 85EZ67055, 85EZ67053, 85EZ67054, 850Y61019, 85EY67044, 85EY67049, 85EZ67052, 85EY67050, 85EZ67051
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

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

Recall #:
87023
Lot/product code:
Serial numbers: 87CY63028, 87CZ63044, 87CZ63045, 87CZ63042, 87CY63025, 87CY63029, 87CY63027, 87CY63030, 87CZ63046, 87CY63034, 87CY63032, 87CY63033
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

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

Recall #:
87023
Lot/product code:
Serial Numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 10, 2020

GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

ALL 50 STATES
▸Full report

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

Recall #:
87023
Lot/product code:
Serial numbers: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013,  860Z62033, 860Z62031
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 11, 2020

VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

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

Recall #:
87028
Lot/product code:
INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302) Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) Extended Recalls: Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021 Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication Reference, CL2021-214) 18 August 2021 Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication Reference, CL2021-274) , 1 November 2021 Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication Reference, CL2023-244) , 27 October 2023 UDI: (1) (10758750004294) (2) (10758750004201
Recalling firm:
Ortho Clinical Diagnostics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2020

VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VENEL10140 /Venovo 8F 10/140/1200mm OUS; VENEL10160 /Venovo 8F10/160/1200mm OUS; VENEL12040 /Venovo 8F 12/40/1200mm OUS; VENEL12060 /Venovo 8F 12/60/1200mm OUS; VENEL12080 /Venovo 8F 12/80/1200mm OUS; VENEL12100 /Venovo 8F 12/100/1200mm OUS; VENEL12120 /Venovo 8F 12/120/1200mm OUS; VENEL12140 /Venovo 8F 12/140/1200mm OUS; VENEL12160 /Venovo 8F 12/160/1200mm OUS; VENEM10040 /Venovo 8F 10/40/800mm OUS; VENEM10060 /Venovo 8F 10/60/800mm OUS; VENEM10080 /Venovo 8F 10/80/800mm OUS; VENEM10100 /Venovo 8F 10/100/800mm OUS; VENEM10120 /Venovo 8F 10/120/800mm OUS; VENEM10140 /Venovo 8F 10/140/800mm OUS; VENEM10160 /Venovo 8F 10/160/800mm OUS; VENEM12040 /Venovo 8F 12/40/800mm OUS; VENEM12060 /Venovo 8F 12/60/800mm OUS; VENEM12080 /Venovo 8F 12/80/800mm OUS; VENEM12100 /Venovo 8F 12/100/800mm OUS; VENEM12120 /Venovo 8F 12/120/800mm OUS; VENEM12140 /Venovo 8F 12/140/800mm OUS; VENEM12160 /Venovo 8F 12/160/800mm OUS; VENUL10040 /Venovo 8F 10/40/1200mm US; VENUL10060 /Venovo 8F 10/60/1200mm US; VENUL10080 /Venovo 8F 10/80/1200mm US; VENUL10100 /Venovo 8F 10/100/1200mm US; VENUL10120 /Venovo 8F 10/120/1200mm US; VENUL10140 /Venovo 8F 10/140/1200mm US; VENUL10160 /Venovo 8F 10/160/1200mm US; VENUL12040 /Venovo 8F 12/40/1200mm US; VENUL12060 /Venovo 8F 12/60/1200mm US; VENUL12080 /Venovo 8F 12/80/1200mm US; VENUL12100 /Venovo 8F 12/100/1200mm US; VENUL12120 /Venovo 8F 12/120/1200mm US; VENUL12140 /Venovo 8F 12/140/1200mm US; VENUL12160 /Venovo 8F 12/160/1200mm US; VENUM10040 /Venovo 8F 10/40/800mm US; VENUM10060 /Venovo 8F 10/60/800mm US; VENUM10080 /Venovo 8F 10/80/800mm US; VENUM10100 /Venovo 8F 10/100/800mm US; VENUM10120 /Venovo 8F 10/120/800mm US; VENUM10140 /Venovo 8F 10/140/800mm US; VENUM10160 /Venovo 8F 10/160/800mm US; VENUM12040 /Venovo 8F 12/40/800mm US; VENUM12060 /Venovo 8F 12/60/800mm US; VENUM12080 /Venovo 8F 12/80/800mm US; VENUM12100 /Venovo 8F 12/100/800mm US; VENUM12120 /Venovo 8F 12/120/800mm US; VENUM12140 /Venovo 8F 12/140/800mm US; VENUM12160 /Venovo 8F 12/160/800mm US;

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

ALL 50 STATES
▸Full report

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

Recall #:
87208
Lot/product code:
Product Code/GTIN: VENEL10040 /00801741102004; VENEL10060 /00801741104664; VENEL10080 /00801741104671; VENEL10100 /00801741102035; VENEL10120 /00801741102042; VENEL10140 /00801741102059; VENEL10160 /00801741102066; VENEL12040 /00801741102141; VENEL12060 /00801741102158; VENEL12080 /00801741102172; VENEL12100 /00801741102189; VENEL12120 /00801741102196; VENEL12140 /00801741102202; VENEL12160 /00801741102219; VENEM10040 /00801741101939; VENEM10060 /00801741101946; VENEM10080 /00801741101953; VENEM10100 /00801741101960; VENEM10120 /00801741101977; VENEM10140 /00801741101984; VENEM10160 /00801741101991; VENEM12040 /00801741102073; VENEM12060 /00801741102080; VENEM12080 /00801741102097; VENEM12100 /00801741102103; VENEM12120 /00801741102110; VENEM12140 /00801741102127; VENEM12160 /00801741102134; VENUL10040 /00801741103209; VENUL10060 /00801741103216; VENUL10080 /00801741103223; VENUL10100 /00801741103230; VENUL10120 /00801741103247; VENUL10140 /00801741103254; VENUL10160 /00801741103261; VENUL12040 /00801741103346; VENUL12060 /00801741103353; VENUL12080 /00801741103360; VENUL12100 /00801741103377; VENUL12120 /00801741103384; VENUL12140 /00801741103391; VENUL12160 /00801741103407; VENUM10040 /00801741103131; VENUM10060 /00801741103148; VENUM10080 /00801741103155; VENUM10100 /00801741103162; VENUM10120 /00801741103179; VENUM10140 /00801741103186; VENUM10160 /00801741103193; VENUM12040 /00801741103278; VENUM12060 /00801741103285; VENUM12080 /00801741103292; VENUM12100 /00801741103308; VENUM12120 /00801741103315; VENUM12140 /00801741103322; VENUM12160 /00801741103339;  U.S. Device; Serial Numbers: ANEQ4079; ANEQ4090; ANEQ4091; ANEQ4101; ANEQ4104; ANEQ4105; ANEQ4109; ANEQ4978; ANEQ4979; ANEQ4980; ANEQ4996; ANEQ4997; ANEQ5023; ANER0477; ANER0478; ANER0490; ANER0491; ANER0510; ANER0515; ANER0532; ANER1502; ANER1528; ANER1529; ANER1530; ANER1533; ANER2795; ANER2796; ANER2797; ANER2812; ANER2813; ANER2814; ANER2815; ANER2816; ANER2838; ANER2841; ANER2855; ANER4217; ANER4228; ANER4236; ANER4238; ANER4239; ANER5126; ANER5127; ANER5136; ANER5141; ANER5142; ANER5153; ANER5159; ANER5160; ANER5169; ANER5175; ANES2223; ANES2224; ANES2233; ANES2234; ANES2235; ANES2236; ANES3045; ANES3050; ANES3067; ANES4102; ANES4103; ANES4111; ANES4112; ANES4113; ANES4114; ANES4115; ANES4116; ANES4117; ANES4118; ANET0561; ANET0566; ANET0567; ANET0568; ANET1490; ANET1508; ANET1509; ANET2533; ANET2534; ANET2535; ANET2536; ANET2537; ANET2540; ANET2541; ANET3797; ANET3798; ANET3799; ANET3800; ANET3814; ANET3815; ANET3816; ANET3817; ANET3818; ANET3877; ANET3878; ANEU0748; ANEU1594; ANEU1601; ANEU1602; ANEU1603; ANEU1604; ANEU1605; ANEU1606; ANEU2442; ANEU3275; ANEU3276; ANEU3277; ANEU3278; ANEU3284; ANEU3285; ANEU3286; ANEU3287; ANEU3288; ANEU3289; ANEU3290; ANEU3306; ANEU4231; ANEU4232; ANEU4238; ANEU4239; ANEU4240; ANEU4246; ANEU4253; ANEU4256; ANEU4260; ANEU4261; ANEU4264; ANEU4265; ANEV0586; ANEV0587; ANEV0591; ANEV0594; ANEV0598; ANEV0599; ANEV0603; ANEV0606; ANEV0611; ANEV0614; ANEV1714; ANEV1715; ANEV1716; ANEV1717; ANEV1718; ANEV1737; ANEV1738; ANEV1739; ANEV1740; ANEV3078; ANEV3079; ANEV3080; ANEV3081; ANEV3082; ANEV3494; ANEV4019; ANEV4020; ANEV4021; ANEV4022; ANEV4023; ANEV4024; ANEV4025; ANEV4043; ANEV4044; ANEV4045; ANEV4046; ANEV4071; ANEV4076; ANEW0553; ANEW0554; ANEW0560; ANEW0561; ANEW0562; ANEW0563; ANEW0564; ANEW0565; ANEW0566; ANEW0599; ANEW0600; ANEW2005; ANEW2006; ANEW2007; ANEW2028; ANEW2029; ANEW2030; ANEW2031; ANEW2032; ANEW2033; ANEW2034; ANEW2239; ANEW2772; ANEW2773; ANEW3378; ANEW3379; ANEW3380; ANEW3381; ANEW3394; ANEW3395; ANEW3396; ANEW3397; ANEW3422; ANEW4229; ANEW4230; ANEW4231; ANEW4232; ANEW4233; ANEW4242; ANEW4243; ANEW4244; ANEW4245; ANEW4246; ANEW4247; ANEW4276; ANEW4280; ANEW4282; ANEW4291; ANEW4297; ANEW4298; ANEW4300; ANEX0704; ANEX0711; ANEX0713; ANEX0720; ANEX0729; ANEX0732; ANEX0735; ANEX0736; ANEX0739; ANEX0740; ANEX0741; ANEX0742; ANEX0743; ANEX0744; ANEX0745; ANEX1737; ANEX1743; ANEX1744; ANEX1746; ANEX1747; ANEX1750; ANEX1752; ANEX1753; ANEX1754; ANEX1755; ANEX3120; ANEX3121; ANEX3123; ANEX3131; ANEX3135; ANEX3136; ANEX3137; ANEX3144; ANEX3145; ANEX3147; ANEX3148; ANEX3149; ANEX3151; ANEX3153; ANEX3154; ANEX3156; ANEX4737; ANEX4740; ANEX4744; ANEX4745; ANEX4751; ANEX4753; ANEX4761; ANEX4762; ANEX4764; ANEX4773; ANEX4779; ANEX4780; ANEX4782; ANEX4783; ANEX4784; ANEX4785; ANEX4786; ANEX4787; ANEX4788; ANEX4789; ANEX6042; ANEX6046; ANEX6049; ANEX6056; ANEX6057; ANEX6065; ANEX6066; ANEX6068; ANEY1246; ANEY1247; ANEY1251; ANEY1257; ANEY1258; ANEY1259; ANEY1262; ANEY1263; ANEY1264; ANEY1265; ANEY1266; ANEY1267; ANEY1268; ANEY1269; ANEY1278; ANEY1279; ANEY1280; ANEY2049; ANEY2050; ANEY2051; ANEY2052; ANEY2053; ANEY2054; ANEY2055; ANEY2056; ANEY3241; ANEY3243; ANEY3245; ANEY3255; ANEY3256; ANEY3257; ANEY3258; ANEY3261; ANEY3537; ANEY3538; ANEY4346; ANEY4354; ANEY4355; ANEY4356; ANEY4357; ANEY4358; ANEY4562; ANEZ0957; ANEZ0958; ANEZ0959; ANEZ0967; ANEZ0972; ANEZ0973; ANEZ0974; ANEZ0980; ANEZ0996; ANEZ0997; ANE… (truncated, 36595 characters total — see the official FDA record for the full value)
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2020

VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16140 Venovo 10F 16/140/1200mm OUS VENEL16160 Venovo 10F 16/160/1200mm OUS VENEL18040 Venovo 10F 18/40/1200mm OUS VENEL18060 Venovo 10F 18/60/1200mm OUS VENEL18080 Venovo 10F 18/80/1200mm OUS VENEL18100 Venovo 10F 18/100/1200mm OUS VENEL18120 Venovo 10F 18/120/1200mm OUS VENEL18140 Venovo 10F 18/140/1200mm OUS VENEL18160 Venovo 10F 18/160/1200mm OUS VENEL20040 Venovo 10F 20/40/1200mm OUS VENEL20060 Venovo 10F 20/60/1200mm OUS VENEL20080 Venovo 10F 20/80/1200mm OUS VENEL20100 Venovo 10F 20/100/1200mm OUS VENEL20120 Venovo 10F 20/120/1200mm OUS VENEL20140 Venovo 10F 20/140/1200mm OUS VENEL20160 Venovo 10F 20/160/1200mm OUS VENEM16040 Venovo 10F 16/40/800mm OUS VENEM16060 Venovo 10F 16/60/800mm OUS VENEM16080 Venovo 10F 16/80/800mm OUS VENEM16100 Venovo 10F 16/100/800mm OUS VENEM16120 Venovo 10F 16/120/800mm OUS VENEM16140 Venovo 10F 16/140/800mm OUS VENEM16160 Venovo 10F 16/160/800mm OUS VENEM18040 Venovo 10F 18/40/800mm OUS VENEM18060 Venovo 10F 18/60/800mm OUS VENEM18080 Venovo 10F 18/80/800mm OUS VENEM18100 Venovo 10F 18/100/800mm OUS VENEM18120 Venovo 10F 18/120/800mm OUS VENEM18140 Venovo 10F 18/140/800mm OUS VENEM18160 Venovo 10F 18/160/800mm OUS VENEM20040 Venovo 10F 20/40/800mm OUS VENEM20060 Venovo 10F 20/60/800mm OUS VENEM20080 Venovo 10F 20/80/800mm OUS VENEM20100 Venovo 10F 20/100/800mm OUS VENEM20120 Venovo 10F 20/120/800mm OUS VENEM20140 Venovo 10F 20/140/800mm OUS VENEM20160 Venovo 10F 20/160/800mm OUS VENUL16040 Venovo 10F 16/40/1200mm US VENUL16060 Venovo 10F 16/60/1200mm US VENUL16080 Venovo 10F 16/80/1200mm US VENUL16100 Venovo 10F 16/100/1200mm US VENUL16120 Venovo 10F 16/120/1200mm US VENUL16140 Venovo 10F 16/140/1200mm US VENUL16160 Venovo 10F 16/160/1200mm US VENUL18040 Venovo 10F 18/40/1200mm US VENUL18060 Venovo 10F 18/60/1200mm US VENUL18080 Venovo 10F 18/80/1200mm US VENUL18100 Venovo 10F 18/100/1200mm US VENUL18120 Venovo 10F 18/120/1200mm US VENUL18140 Venovo 10F 18/140/1200mm US VENUL18160 Venovo 10F 18/160/1200mm US VENUL20040 Venovo 10F 20/40/1200mm US VENUL20060 Venovo 10F 20/60/1200mm US VENUL20080 Venovo 10F 20/80/1200mm US VENUL20100 Venovo 10F 20/100/1200mm US VENUL20120 Venovo 10F 20/120/1200mm US VENUL20140 Venovo 10F 20/140/1200mm US VENUL20160 Venovo 10F 20/160/1200mm US VENUM16040 Venovo 10F 16/40/800mm US VENUM16060 Venovo 10F 16/60/800mm US VENUM16080 Venovo 10F 16/80/800mm US VENUM16100 Venovo 10F 16/100/800mm US VENUM16120 Venovo 10F 16/120/800mm US VENUM16140 Venovo 10F 16/140/800mm US VENUM16160 Venovo 10F 16/160/800mm US VENUM18040 Venovo 10F 18/40/800mm US VENUM18060 Venovo 10F 18/60/800mm US VENUM18080 Venovo 10F 18/80/800mm US VENUM18100 Venovo 10F 18/100/800mm US VENUM18120 Venovo 10F 18/120/800mm US VENUM18140 Venovo 10F 18/140/800mm US VENUM18160 Venovo 10F 18/160/800mm US VENUM20040 Venovo 10F 20/40/800mm US VENUM20060 Venovo 10F 20/60/800mm US VENUM20080 Venovo 10F 20/80/800mm US VENUM20100 Venovo 10F 20/100/800mm US VENUM20120 Venovo 10F 20/120/800mm US VENUM20140 Venovo 10F 20/140/800mm US VENUM20160 Venovo 10F 20/160/800mm US

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

ALL 50 STATES
▸Full report

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

Recall #:
87208
Lot/product code:
Product Code/GTIN: VENEL16040 /00801741102431; VENEL16060 /00801741102448; VENEL16080 /00801741102455; VENEL16100 /00801741102462; VENEL16120 /00801741102479; VENEL16140 /00801741102486; VENEL16160 /00801741102493; VENEL18040 /00801741102578; VENEL18060 /00801741102585; VENEL18080 /00801741102592; VENEL18100 /00801741102608; VENEL18120 /00801741102967; VENEL18140 /00801741102974; VENEL18160 /00801741102981; VENEL20040 /00801741103063; VENEL20060 /00801741103070; VENEL20080 /00801741103087; VENEL20100 /00801741103094; VENEL20120 /00801741103100; VENEL20140 /00801741103117; VENEL20160 /00801741103124; VENEM16040 /00801741102363; VENEM16060 /00801741102370; VENEM16080 /00801741102387; VENEM16100 /00801741102394; VENEM16120 /00801741102400; VENEM16140 /00801741102417; VENEM16160 /00801741102424; VENEM18040 /00801741102509; VENEM18060 /00801741102516; VENEM18080 /00801741102523; VENEM18100 /00801741102530; VENEM18120 /00801741102547; VENEM18140 /00801741102554; VENEM18160 /00801741102561; VENEM20040 /00801741102998; VENEM20060 /00801741103001; VENEM20080 /00801741103018; VENEM20100 /00801741103025; VENEM20120 /00801741103032; VENEM20140 /00801741103049; VENEM20160 /00801741103056; VENUL16040 /00801741103629; VENUL16060 /00801741103636; VENUL16080 /00801741103643; VENUL16100 /00801741103650; VENUL16120 /00801741103667; VENUL16140 /00801741103674; VENUL16160 /00801741103681; VENUL18040 /00801741103766; VENUL18060 /00801741103773; VENUL18080 /00801741103780; VENUL18100 /00801741103797; VENUL18120 /00801741103803; VENUL18140 /00801741103810; VENUL18160 /00801741103827; VENUL20040 /00801741103902; VENUL20060 /00801741103919; VENUL20080 /00801741103926; VENUL20100 /00801741103933; VENUL20120 /00801741103940; VENUL20140 /00801741103957; VENUL20160 /00801741103964; VENUM16040 /00801741103551; VENUM16060 /00801741103568; VENUM16080 /00801741103575; VENUM16100 /00801741103582; VENUM16120 /00801741103599; VENUM16140 /00801741103605; VENUM16160 /00801741103612; VENUM18040 /00801741103698; VENUM18060 /00801741103704; VENUM18080 /00801741103711; VENUM18100 /00801741103728; VENUM18120 /00801741103735; VENUM18140 /00801741103742; VENUM18160 /00801741103759; VENUM20040 /00801741103834; VENUM20060 /00801741103841; VENUM20080 /00801741103858; VENUM20100 /00801741103865; VENUM20120 /00801741103872; VENUM20140 /00801741103889; VENUM20160 /00801741103896;  U.S. Devices Serial Numbers: ANEQ5007; ANEQ5008; ANEQ5009; ANEQ5010; ANEQ5011; ANEQ5012; ANEQ5013; ANEQ5014; ANEQ5015; ANEQ5016; ANEQ5017; ANEQ5018; ANEQ5019; ANEQ5020; ANEQ5021; ANEQ5022; ANER0482; ANER0483; ANER0484; ANER0485; ANER0486; ANER0487; ANER0488; ANER0489; ANER0494; ANER0495; ANER0496; ANER0497; ANER0498; ANER0499; ANER0500; ANER0501; ANER0502; ANER0503; ANER0504; ANER0511; ANER0512; ANER0513; ANER0514; ANER0530; ANER0531; ANER1498; ANER1499; ANER1500; ANER1501; ANER1504; ANER1505; ANER1506; ANER1531; ANER1532; ANER2801; ANER2802; ANER2803; ANER2804; ANER2805; ANER2806; ANER2807; ANER2808; ANER2809; ANER2810; ANER2811; ANER2820; ANER2821; ANER2822; ANER2823; ANER2824; ANER2825; ANER2826; ANER2827; ANER2828; ANER2829; ANER2830; ANER2831; ANER2832; ANER2833; ANER2834; ANER2835; ANER2836; ANER2839; ANER2840; ANER2842; ANER2843; ANER2844; ANER2846; ANER2847; ANER2848; ANER2849; ANER2850; ANER2856; ANER2857; ANER4199; ANER4200; ANER4201; ANER4203;; ANER4204; ANER4206; ANER4207; ANER4208; ANER4209; ANER4212; ANER4214; ANER4215; ANER4218; ANER4220; ANER4222; ANER4223; ANER4224; ANER4226; ANER4227; ANER4229; ANER4230; ANER4231; ANER4233; ANER4234; ANER4235; ANER4237; ANER4240; ANER4241; ANER4242; ANER4243; ANER5123; ANER5124; ANER5125; ANER5129; ANER5130; ANER5131; ANER5132; ANER5133; ANER5139; ANER5140; ANER5144; ANER5145; ANER5146; ANER5147; ANER5148; ANER5155; ANER5156; ANER5157; ANER5158; ANER5162; ANER5163; ANER5164; ANER5171; ANER5172; ANER5173; ANER5174; ANER5179; ANER5180; ANER5181; ANES1051; ANES1052; ANES1053; ANES1054; ANES1055; ANES1056; ANES1057; ANES1058; ANES1059; ANES2227; ANES2228; ANES2229; ANES2230; ANES2231; ANES2232; ANES2238; ANES3025; ANES3026; ANES3027; ANES3028; ANES3029; ANES3030; ANES3031; ANES3032; ANES3033; ANES3034; ANES3035; ANES3036; ANES3037; ANES3038; ANES3041; ANES3042; ANES3043; ANES3044; ANES3046; ANES3047; ANES3048; ANES3049; ANES3053; ANES3054; ANES3055; ANES3056; ANES3059; ANES3060; ANES3065; ANES3066; ANES3068; ANES4105; ANES4106; ANES4107; ANES4108; ANES4109; ANES4110; ANES4120; ANES4121; ANES4122; ANES4123; ANES4124; ANES4125; ANES4126; ANES4127; ANES4128; ANET0562; ANET0563; ANET0564; ANET0565; ANET0575; ANET0576; ANET0577; ANET0578; ANET0579; ANET0580; ANET0581; ANET0582; ANET0583; ANET1080; ANET1081; ANET1082; ANET1083; ANET1084; ANET1471; ANET1472; ANET1473; ANET1474; ANET1475; ANET1476; ANET1477; ANET1478; ANET1479; ANET1480; ANET1481; ANET1482; ANET1483; ANET1484; ANET1489; ANET1491; ANET1492; ANET1493; ANET1494; ANET1495; ANET1496; ANET1497; ANET1499; ANET1500; ANET1501; ANET1506; ANET1507; ANET2539; ANET2545; ANET2546; ANET2547… (truncated, 87873 characters total — see the official FDA record for the full value)
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2020

VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VENEL14140 /Venovo 9F 14/140/1200mm OUS; VENEL14160 /Venovo 9F 14/160/1200mm OUS; VENEM14040 /Venovo 9F 14/40/800mm OUS; VENEM14060 /Venovo 9F 14/60/800mm OUS; VENEM14080 /Venovo 9F 14/80/800mm OUS; VENEM14100 /Venovo 9F 14/100/800mm OUS; VENEM14120 /Venovo 9F 14/120/800mm OUS; VENEM14140 /Venovo 9F14/140/800mm OUS; VENEM14160 /Venovo 9F 14/160/800mm OUS; VENUL14040 /Venovo 9F 14/40/1200mm US; VENUL14060 /Venovo 9F 14/60/1200mm US; VENUL14080 /Venovo 9F 14/80/1200mm US; VENUL14100 /Venovo 9F 14/100/1200mm US; VENUL14120 /Venovo 9F 14/120/1200mm US; VENUL14140 /Venovo 9F 14/140/1200mm US; VENUL14160 /Venovo 9F 14/160/1200mm US; VENUM14040 /Venovo 9F 14/40/800mm US; VENUM14060 /Venovo 9F 14/60/800mm US; VENUM14080 /Venovo 9F 14/80/800mm US; VENUM14100 /Venovo 9F 14/100/800mm US; VENUM14120 /Venovo 9F 14/120/800mm US; VENUM14140 /Venovo 9F 14/140/800mm US; VENUM14160 /Venovo 9F 14/160/800mm US;

Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

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

Recall #:
87208
Lot/product code:
Product Code/GTIN: VENEL14040 /00801741102295; VENEL14060 /00801741102301; VENEL14080 /00801741102318; VENEL14100 /00801741102325; VENEL14120 /00801741102332; VENEL14140 /00801741102349; VENEL14160 /00801741102356; VENEM14040 /00801741102226; VENEM14060 /00801741102233; VENEM14080 /00801741102240; VENEM14100 /00801741102257; VENEM14120 /00801741102264; VENEM14140 /00801741102271; VENEM14160 /00801741102288; VENUL14040 /00801741103483; VENUL14060 /00801741103490; VENUL14080 /00801741103506; VENUL14100 /00801741103513; VENUL14120 /00801741103520; VENUL14140 /00801741103537; VENUL14160 /00801741103544; VENUM14040 /00801741103414; VENUM14060 /00801741103421; VENUM14080 /00801741103438; VENUM14100 /00801741103445; VENUM14120 /00801741103452; VENUM14140 /00801741103469; VENUM14160 /00801741103476;  U.S. Device Serial Numbers: ANEP2484; ANEP2485; ANEP2487; ANEP3962; ANEP3964; ANEP3966; ANEP3968; ANEP3972; ANEP3973; ANEP3979; ANEP3982; ANEP3986; ANEP5357; ANEP5362; ANEP5363; ANEP5364; ANEP5367; ANEP5368; ANEP5370; ANEP5373; ANEP5375; ANEP5378; ANEQ0213; ANEQ0216; ANEQ0217; ANEQ0219; ANEQ0220; ANEQ0221; ANEQ1381; ANEQ1382; ANEQ1383; ANEQ1384; ANEQ1402; ANEQ1403; ANEQ1404; ANEQ1405; ANEQ1406; ANEQ1407; ANEQ1408; ANEQ1409; ANEQ1410; ANEQ1411; ANEQ2758; ANEQ2759; ANEQ2777; ANEQ2778; ANEQ3075; ANEQ3076; ANEQ4080; ANEQ4081; ANEQ4082; ANEQ4083; ANEQ4092; ANEQ4093; ANEQ4094; ANEQ4106; ANEQ4387; ANEQ4747; ANEQ4748; ANEQ4749; ANEQ4752; ANEQ4981; ANEQ4982; ANEQ4983; ANEQ4984; ANEQ4985; ANEQ4998; ANEQ4999; ANEQ5000; ANEQ5001; ANEQ5002; ANER0479; ANER0480; ANER0481; ANER0492; ANER0493; ANER0533; ANER0534; ANER1497; ANER1503; ANER2390; ANER2391; ANER2392; ANER2393; ANER2394; ANER2395; ANER2798; ANER2799; ANER2800; ANER2817; ANER2818; ANER2819; ANER2837; ANER2845; ANER2851; ANER2852; ANER2853; ANER2854; ANER4202; ANER4205; ANER4210; ANER4211; ANER4213; ANER4216; ANER4219; ANER4221; ANER4225; ANER4232; ANER5121; ANER5122; ANER5128; ANER5137; ANER5138; ANER5143; ANER5154; ANER5161; ANER5170; ANER5176; ANER5177; ANER5178; ANES1034; ANES1050; ANES2225; ANES2226; ANES2237; ANES3023; ANES3039; ANES3040; ANES3051; ANES3052; ANES3057; ANES3058; ANES3061; ANES3062; ANES3063; ANES3064; ANES3130; ANES4104; ANES4119; ANET0569; ANET0570; ANET0571; ANET0572; ANET0573; ANET0574; ANET1485; ANET1486; ANET1487; ANET1488; ANET1498; ANET1502; ANET1503; ANET1504; ANET1505; ANET2538; ANET2542; ANET2543; ANET2544; ANET2560; ANET2568; ANET2569; ANET2570; ANET2571; ANET2572; ANET3801; ANET3802; ANET3803; ANET3819; ANET3820; ANET3821; ANET3822; ANET3823; ANET3842; ANET3879; ANET3880; ANEU0744; ANEU0749; ANEU0750; ANEU0751; ANEU0752; ANEU0753; ANEU0754; ANEU0772; ANEU1595; ANEU1607; ANEU1608; ANEU1609; ANEU1610; ANEU1627; ANEU2434; ANEU2435; ANEU2436; ANEU2443; ANEU2444; ANEU2445; ANEU2446; ANEU2447; ANEU2448; ANEU3279; ANEU3291; ANEU3292; ANEU3293; ANEU3294; ANEU4228; ANEU4233; ANEU4234; ANEU4241; ANEU4242; ANEU4247; ANEU4248; ANEU4249; ANEU4257; ANEV0589; ANEV0597; ANEV0600; ANEV0604; ANEV0615; ANEV1719; ANEV1720; ANEV1721; ANEV1722; ANEV1741; ANEV1742; ANEV1743; ANEV1744; ANEV1745; ANEV2618; ANEV3071; ANEV3072; ANEV3083; ANEV3084; ANEV3085; ANEV3497; ANEV4026; ANEV4027; ANEV4028; ANEV4029; ANEV4030; ANEV4047; ANEV4048; ANEV4049; ANEV4050; ANEV4051; ANEV4074; ANEW0555; ANEW0567; ANEW0568; ANEW0569; ANEW0570; ANEW0571; ANEW0572; ANEW0573; ANEW0574; ANEW0596; ANEW0597; ANEW1518; ANEW1586; ANEW2008; ANEW2009; ANEW2010; ANEW2011; ANEW2035; ANEW2036; ANEW2236; ANEW2237; ANEW2530; ANEW2774; ANEW3382; ANEW3383; ANEW3384; ANEW3385; ANEW3398; ANEW3399; ANEW3400; ANEW3423; ANEW3425; ANEW3426; ANEX0698; ANEX0714; ANEX0718; ANEX0725; ANEX0756; ANEX1728; ANEX1729; ANEX1731; ANEX1732; ANEX1733; ANEX1735; ANEX1738; ANEX1741; ANEX1745; ANEX1749; ANEX3102; ANEX3103; ANEX3106; ANEX3107; ANEX3108; ANEX3109; ANEX3110; ANEX3111; ANEX3114; ANEX3128; ANEX3133; ANEX3134; ANEX3140; ANEX4723; ANEX4724; ANEX4727; ANEX4728; ANEX4729; ANEX4739; ANEX4741; ANEX4749; ANEX4754; ANEX4757; ANEX4771; ANEX4774; ANEX4776; ANEX6029; ANEX6030; ANEX6031; ANEX6040; ANEX6041; ANEX6043; ANEX6044; ANEX6047; ANEX6050; ANEX6051; ANEX6058; ANEX6069; ANEY1238; ANEY1239; ANEY1245; ANEY1252; ANEY1253; ANEY1260; ANEY1261; ANEY1270; ANEY1271; ANEY1281; ANEY2057; ANEY2058; ANEY2059; ANEY2060; ANEY2061; ANEY2062; ANEY2063; ANEY3215; ANEY3216; ANEY3219; ANEY3220; ANEY3221; ANEY3222; ANEY3223; ANEY3224; ANEY3227; ANEY3228; ANEY3229; ANEY3230; ANEY3233; ANEY3234; ANEY3259; ANEY4238; ANEY4330; ANEY4331; ANEY4332; ANEY4333; ANEY4334; ANEY4335; ANEY4336; ANEY4337; ANEY4338; ANEY4339; ANEY4340; ANEY4341; ANEY4342; ANEY4343; ANEY4348; ANEY4559; ANEY4561; ANEZ0934; ANEZ0935; ANEZ0936; ANEZ0938; ANEZ0939; ANEZ0940; ANEZ0941; ANEZ0942; ANEZ0943; ANEZ0946; ANEZ0947; ANEZ0948; ANEZ0949; ANEZ0950; ANEZ0951; ANEZ0952; ANEZ0953; ANEZ1475; ANEZ2108; ANEZ2114; ANEZ2115; ANEZ2116; ANEZ2117; ANEZ2125; ANEZ2126; ANEZ2127; ANEZ2128; ANEZ2129; ANEZ2130; ANEZ2141; ANEZ2142; ANEZ2143; ANEZ2144; ANEZ2145; ANEZ2146; ANEZ3440; ANEZ3441… (truncated, 45631 characters total — see the official FDA record for the full value)
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2020

REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

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

Recall #:
87069
Lot/product code:
Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2020

REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

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▸Full report

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

Recall #:
87069
Lot/product code:
Lot # 0219281777
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2020

REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

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▸Full report

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

Recall #:
87069
Lot/product code:
Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505
Recalling firm:
Medtronic Neurosurgery
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled December 17, 2020

ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label)

Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

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

Recall #:
D-0269-2021
Lot/product code:
LOT # 2010045; Best Before 10 2023
Recalling firm:
NDAL Mfg Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 21, 2020

PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.

Medical device non-conformance to electrical safety standard (IEC 60601-1).

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

Recall #:
87011
Lot/product code:
Serial numbers 3. Serial numbers 320, 470, 507, 534, 621, 757, 770, 795, 892, 1165-1183, 1186- 1205, 1214-1293, 1295-1297, 1304-1330, 1333-1342, 1358 -1384, 1387-1389, 1391-1413, 1421-1430, 1434-1505, 1507- 1516.
Recalling firm:
Nihon Kohden America Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

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

Recall #:
88225
Lot/product code:
All lots sold prior to December 9, 2019.
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

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

Recall #:
88225
Lot/product code:
All lots sold prior to December 9, 2019.
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

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

Recall #:
88225
Lot/product code:
All lots sold prior to December 9, 2019.
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)

Device was distributed without a proper marketing authorization.

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)

Device was distributed without a proper marketing authorization.

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Premium At Home Pro Series Insemination Kit (SKU 644042787927)

Device was distributed without a proper marketing authorization.

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2020

Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)

Device was distributed without a proper marketing authorization.

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

Recall #:
87581
Lot/product code:
All lots
Recalling firm:
Tenderneeds Fertility LLC
View official FDA record (opens in a new tab)