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Recalls affecting Minnesota

Data last updated: September 8, 2026 at 1:13 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/virusAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: February 2023 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: February 2023 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: December 2022 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: February 2023 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: February 2023 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: February 2023 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: December 2022 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: February 2023 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: February 2023 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: December 2022 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 11, 2019

Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

ALL 50 STATES
Full report

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

Recall #:
82539
Lot/product code:
All Lots within EXPIRATION Date Range: December 2022 March 2024
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 18, 2019

Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1266-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lot 4DU3E016, exp 01/31/2021; [1000-count bottle] Lot 4DU3C012, exp 7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031, exp 9/30/2019; Lots 4DU3D007, 4DU3D008, exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021; Lot 4DU3E019, exp 2/28/2021
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 18, 2019

Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1265-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lots 4DU2D005, 4DU2D006, exp 12/31/2019; Lots 4DU2D026, 4DU2D027, 4DU2D029, exp 3/31/2020; Lot 4DU2E007, exp 12/31/2020; [1000-count bottle] Lot 4DU2D017, exp 2/29/2020, Lots 4DU2D025, 4DU2D028, exp 3/31/2020; Lots 4DU2D040, 4DU2D041, 4DU2D042, 4DU2D045, 4DU2D046, 4DU2D047, 4DU2D048, exp 8/31/2020; Lot BDK2E001, exp 12/31/2020; Lots 4DU2E042, 4DU2E044, exp 2/28/2021; Lots BDK2E012, BDK2E013, exp 8/31/2021
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 18, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1267-2019
Lot/product code:
Count, lots, expiry: [30-count bottle] Lot BP02C051, exp 10/31/2019; Lot BP02D005, exp 12/31/2019; Lot BEF7D047, exp 11/30/2020; [90-count bottle] Lot BP02C050, exp 10/31/2019; Lots BP02D006, BP02D007, exp 12/31/2019; Lot BP02D012, exp 1/31/2020; Lot BEF7D003, exp 3/31/2020; Lots BEF7D026, BEF7D027, BEF7D028, exp 8/31/2020; Lots BEF7D045, BEF7D046, exp 11/30/2020; Lot BEF7E005, exp 1/31/2021; [1000-count bottle] Lots BP02C051, BP02C052, exp 10/31/2019; Lot BEF7D005, exp 3/31/2020; Lots BEF7D029, BEF7D030, exp 8/31/2020; Lot BEF7D048, exp 11/30/2020; Lots BEF7E001, BEF7E002, BEF7E003, BEF7E004, exp 12/31/2020
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 18, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1268-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lot BX35D024, exp 1/31/2020; BEF8D060, BEF8D061, BEF8D062, BEF8D063, BEF8D064, exp 11/30/2020; [1000-count bottle] Lot BEF8D059, exp 11/30/2020; Lots BEF8E004, BEF8E005, exp 1/31/2021
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 18, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1269-2019
Lot/product code:
Count, lots, expiry: [30-count bottle] Lot BEF6D054, exp 8/31/2020; [90-count bottle] Lot BP04C092, exp 10/31/2019; Lots BP04D012, BP04D013, exp 12/31/2019; Lots BEF6D012, BEF6D013, exp 3/31/2020; Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020; Lots BEF6D076, BEF6D077, BEF6D078, BEF6D079, exp 10/31/2020; Lots BEF6D100, BEF6D101, BEF6D102, exp 11/30/2020; Lots BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, BEF6E012, exp 12/31/2020
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 18, 2019

Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1264-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lot BDK1C003, exp 07/31/2019; [1000-count bottle] Lot BDK1C002, exp 07/31/2019; Lots 4DU1D004, 4DU1D005, 4DU1D006, exp 12/31/2019
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All  Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2019

SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

ALL 50 STATES
Full report

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

Recall #:
82684
Lot/product code:
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)