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Recalls affecting Minnesota

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

16,909 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 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-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 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 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 5, 2020

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

Full report

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

Recall #:
85252
Lot/product code:
Serial Numbers: 1507T719-00-0-0087 1509T719-00-0-0142 1509T719-00-0-0144 1509T719-00-0-0139 1507T719-00-0-0085 1509T719-00-0-0135 1508T719-00-0-0115 1508T719-00-0-0116 1508T719-00-0-0119 1508T719-00-0-0120 1507T719-00-0-0074 1508T719-00-0-0129 1508T719-00-0-0121 1508T719-00-0-0123 1508T719-00-0-0124 1508T719-00-0-0125 1508T719-00-0-0126 1509T719-00-0-0132 1509T719-00-0-0146 1507T719-00-0-0103 1507T719-00-0-0104 1507T719-00-0-0053 1507T719-00-0-0054 1507T719-00-0-0055 1507T719-00-0-0056 1507T719-00-0-0058 1507T719-00-0-0059 1507T719-00-0-0061 1507T719-00-0-0062 1507T719-00-0-0063 1507T719-00-0-0064 1508T719-00-0-0127 1508T719-00-0-0128 1510T719-00-0-0153 1510T719-00-0-0154 1510T719-00-0-0157 1510T719-00-0-0160 1510T719-00-0-0166 1508T719-00-0-0118 1510T719-00-0-0159 1508T719-00-0-0114 1508T719-00-0-0117 1508T719-00-0-0122
Recalling firm:
Skytron, Div. The KMW Group, Inc
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

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 .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

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 /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 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 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

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 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)
UnclassifiedRisk not yet known
Medical deviceRecalled March 12, 2020

Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

ALL 50 STATES
Full report

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

Recall #:
85310
Lot/product code:
All serial numbers
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 12, 2020

Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

ALL 50 STATES
Full report

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

Recall #:
85310
Lot/product code:
All serial numbers
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 17, 2020

Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.

ALL 50 STATES
Full report

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

Recall #:
85296
Lot/product code:
Lot Numbers: 2012020 2012021 2012022 2013822 2013823 2013887 2013888 2013914 2013915 2013954 2016801 2017394 2017397 2017401 2017759 2017760 2017763 2017764 2017768 2017771 2017815 2017816 2017817 2017846 2017847 2017848 2017849 2018638 2018742 2018799 2018800 2018853 2019892 2019991 2020052 2021389 2021498 2021546 2023225 2023273 2023274 2023336 2023337 2024762 2024764 2024806 2024808 2025068 2025070 2025157 2025160 2025163 2025290 2025291 2025342 2026561 2027397 2027428 2027460 2028121 2028122 2028618 2028619 2028749 2028750 2028751 2029248 2029249 2029250 2029291 2029292 2029293 2029294 2029334 2029335 2029336 2029383 2029384 2029385 2030933 2030934 2030935 2030936 2031067 2031068 2031069 2031070 2031071 2031072 2031073 2031074 2031075 2031076 2031141 2031142 2031143 2031144 2032807 2032808 2032809 2032810 2032811 2033267 2033268 2033269 2033270 2033271 2033382 2033383 2033384 2033385 2033386 2033514 2033515 2033516 2033663 2034412 2034413 2034414 2034415 2034416 2034477 2034478 2034479 2034480 2034481 2035480 2035481 2035482 2035483 2035484 2036292 2036293 2036294 2036295 2036296 2036297 2036698 2036699 2036700 2037117 2037118 2037119 2037120 2037121 2037170 2038309 2038310 2038311 2038312 2038442 2038443 2038445 2038446 2038447 2038782 2038783 2038914 2038915 2039242 2039243 2039244 2039432 2039433 2039434 2039592 2039593 2039594 2040094 2040095 2040096 2040722 2040723 2040724 2040725 2040726 2041191 2041192 2041193 2041431 2041547 2041777 2041778 2042760 2042761 2042762 2044877 2044878 2044879 2044880 2044881 2044882 2044883 2045839 2045840 2045841 2045842 50721044 50721045 50721046 50721227 50721228 50721919 50721920 50721921 50721922 50722408 50723098 50723389 50723390 50723723 50724821 50725276 50725277 50725278 50725279 50725989 50726256 50726257 50726260 50726261 50726557 50727072 50727077 50727078 50727524 50727525 50730874 50730875 50734022 50734023 50734024 50734030 50734033 50734034 50734036 50734037 50734039 50734040 50734042 50734043 50735323 50736230 50736233 50736235 50736236 50736237 50737179 50738897 50739104 50740014 50740015 50740167 50740168 50740169 50741211 50741832 50741833 50741834 50741835 50742583 50742584 50743462 50743463 50743738 50743739 50744055 50744056 50744328 50744329 50744775 50744776 50745436 50745437 50745438 50746626 50746627 50746801 50746802 50746803 50746804 50746806 50748497 50751200 50751201 50752128 50752129 50753568 50753569 50753570 50753571 50754486 50754487 50754493 50754494 50754495 50755636 50755851 50755852 50755853 50755854 50755855 50755997 50756146 50756147 50756148 50756149 50757521 50757522 50757523 50757525 50757733 50757738 50757739 50757740 50757742 50758325 50758326 50758327 50759485 50759486 50761327 50761857 50761860 50761863 50762247 50762248 50763843 50763845 50763849 50763861 50763862 50763864 50764542 50764753 50764754 50765679 50765680 50765941 50765942 50766196 50766197 50766198 50766562 50766563 50767112 50767113 50767823 50767824 50769322 50769323 50769324 50769325 50770401 50770402 50770798 50770799 50771037 50771038 50771157 50771158 50773884 50773885 50773886 50773887 50774343 50781296 50781297 50781996 50781997 50783242 50783243 50783244 50783246 50783247 50783249 50783779 50783780 50784093 50784094 50784095 50784394 50784395 50785260 50785503 50786022 50787963 50787964 50787965 50787966 50787967 50787968 50787969 50788373 50788682 50793414 50793415 50793416 50793870 50795928 50795929 50795934 50795935 50800432 50800433 50801025 50802121 50803206 50803207 50806300 50806302 50806303 50807428 50807429 50811206 50811208 50812377 50815363 50815808 50821887 50821888 50821890 50821891 50829130 50829131 50829132 50829133 50829134 50829135 50831610 50831611 50831981 50831982 50831984 50831985 50837351 50837352
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 17, 2020

RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.

RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.

ALL 50 STATES
Full report

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

Recall #:
85270
Lot/product code:
LOT K030.
Recalling firm:
Rayner Intraocular Lenses Limited
View official FDA record (opens in a new tab)