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Recalls affecting Louisiana

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

16,895 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
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)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2020

Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.

The firm received reports of a number of broken latches on the floorsitter.

ALL 50 STATES
Full report

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

Recall #:
85086
Lot/product code:
LEC/178486 to LEC/206637; LEC/189092 to LEC/204087; Firefly Splashy-All codes beginning 176; Firefly GoTo Seat-All codes beginning 167 and including letter F in code.
Recalling firm:
James Leckey Design Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2020

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

ALL 50 STATES
Full report

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

Recall #:
85030
Lot/product code:
Lot 306UL
Recalling firm:
Randox Laboratories Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

ALL 50 STATES
Full report

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1121419 1124919
Recalling firm:
Gentell, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

ALL 50 STATES
Full report

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919
Recalling firm:
Gentell, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

ALL 50 STATES
Full report

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919
Recalling firm:
Gentell, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2020

Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

During an FDA audit, it was discovered that the product was not properly registered with FDA.

ALL 50 STATES
Full report

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

Recall #:
85034
Lot/product code:
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919
Recalling firm:
Gentell, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2020

Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

ALL 50 STATES
Full report

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

Recall #:
85309
Lot/product code:
Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001, AGB1712007, AGC1952014, AGB1482001, AGC1822011, BGB1992001, AGC18X2013, AGB16Z2006
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2020

Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

ALL 50 STATES
Full report

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

Recall #:
85309
Lot/product code:
Serial Numbers: B8B1972001, A9A1592001, A3A14Z2001, AEB1812002, A1B1552001, A9C18Y2007, A3E1922002, B5B1952001, A9C1822006, A9B1622002, A9B1722003, A5C1622001, B3B19Y2001, A1D1772003, B1B19X2001, A5C16Y2002, A9C1822005, A1E1862008, A1D1752002, A1E1832004, A1E1852005, A1E1852006, A5E1862003, AEA17X2001
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 3, 2020

Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

ALL 50 STATES
Full report

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

Recall #:
85309
Lot/product code:
Serial Numbers: A5B1642006, A1B17X2004, A5A1612005, A5B1772009, B5B1962002, A3A1522004, A7B16Y2001, A3A1712011, A5B1792010, A5A1532002, A1A1612003, A3A15Z2007, A5A1552003, A5B16Y2007, A3B1862016, A3B1812013, A3A1662009, A9A16X2004, BTA1922001, A3B1842015, AOB1882001, BMB1942001, AOB1892002, A5B1472001, A5B17Z2011, A3A14X2002, A5A1592004, A3A17Z2012, A5C1832012, A5B16Z2008, A1A1582002, A9A1582002, A1A14X2001, A3A1512003, A7C1812002, ABC18X2002, A3A1592005, UTC14Y2008, A3A15X2006, B5B1942001, A3A1682010, A1C18Z2005, A9A1662003, A3A1492001, A3B1822014, A3A1622008
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 4, 2020

RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.

ALL 50 STATES
Full report

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

Recall #:
85255
Lot/product code:
Systems with software versions: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 or 9.1.0.933
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2020

Philips V60 Ventilators with Power Management PCBA part number 1055906

Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia

Full report

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

Recall #:
85113
Lot/product code:
Serial Numbers: 100002908 to 100027093; 100027096 to 100085389; 100085399 to 100109746; 100109868 to 201003390; 201003392 to 201010952
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 6, 2020

AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.

The UDI on the device label indicates incorrect manufacturer.

ALL 50 STATES
Full report

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

Recall #:
85094
Lot/product code:
Model Number 4BCPPB-3XCZ0002 (Lot Numbers PPB1155 - PPB1174, PPB1194 - PPB1213, PPB1222 - PPB1241, PPB1265 - PPB1284, PPB1292 - PPB1311, PPB1346 - PPB1365, PPB1375 - PPB1394, PPB1451 - PPB1466, PPB1477 - PPB1496, PPB1508 - PPB1527);   Model Number 4BCPPB-CCZ0008, Lot Number PPB1446 - PPB1449;  Model Number 4BCPPB-BCZ0009, Lot Number PPB1541 - PPB1542
Recalling firm:
Linet Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24879999, 25021676
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24538844, 24647121
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Number: 24835477 (edited 1/13/2021)
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24501748, 24506585, 24507390, 24507747, 24517205, 24517209, 24517211, 24526341, 24576484, 24576569, 24577900, 24579133, 24580102, 24583255, 24585905, 24586401, 24616721, 24617337, 24618334, 24724936, 24732742, 24737184, 24739802, 24790717, 24805720, 24860825, 24868932
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24423656, 24423820, 24424087, 24427952, 24427959, 24428330, 24430010, 24437882, 24440182, 24440998, 24444952, 24446611, 24447516, 24447658, 24447722, 24447735, 24451828, 24452126, 24452132, 24452266, 24454238, 24455297, 24455381, 24455732, 24460452, 24460458, 24466032, 24487805, 24493956, 24494611, 24498583, 24498730, 24498732, 24499924, 24501439, 24506583, 24563429, 24563891, 24564727, 24564729, 24569684, 24570465, 24571203, 24579763, 24599358, 24609013, 24609991, 24614307, 24615296, 24620493, 24621357, 24621789, 24622541, 24623111, 24623117, 24623321, 24623461, 24623472, 24640257, 24661651, 24662199, 24663152, 24663562, 24663570, 24665001, 24665005, 24665100, 24665108, 24665990, 24666401, 24670677, 24672232, 24672553, 24678045, 24678047, 24681044, 24699798, 24700605, 24702016, 24708365, 24708371, 24709540, 24709550, 24710261, 24716280, 24716623, 24719303, 24723783, 24724284, 24732445, 24732731, 24738283, 24751717, 24756104, 24758578, 24763250, 24765356, 24766287, 24766401, 24772737, 24773528
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24484631, 24494135, 24494288, 24533782, 24584655, 24617736, 24625474, 24665994, 24723912
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24755842
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24749818, 24913418
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24724232
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24755840
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Number: 24958079 (edited 1/13/2021)
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2020

Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

ALL 50 STATES
Full report

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

Recall #:
85227
Lot/product code:
Lot Numbers: 24795838
Recalling firm:
Boston Scientific
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceBacteria/virusStaphylococcusRecalled March 11, 2020

The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .

ALL 50 STATES
Full report

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

Recall #:
85209
Lot/product code:
VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
Recalling firm:
Biomerieux Inc
View official FDA record (opens in a new tab)