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Recalls affecting South Dakota

Data last updated: September 10, 2026 at 1:16 PM UTC

16,341 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.

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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

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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

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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.

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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)
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

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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)
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 May 5, 2021

Omnera 400A Digital Radiographic System

There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

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Full report

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

Recall #:
90446
Lot/product code:
UDI/DI: 07350008750012; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.
Recalling firm:
Arcoma AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 5, 2021

Omnera 400T Digital Radiographic System

There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

ALL 50 STATES
Full report

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

Recall #:
90446
Lot/product code:
UDI/DI:07350008750050; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.
Recalling firm:
Arcoma AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 10, 2021

Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.

ALL 50 STATES
Full report

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

Recall #:
87838
Lot/product code:
Catalog Number: PRT-00490-001 GTIN (Primary ID): 00855573007792/00855573007006 Serial Numbers: 114303; 114304; 113728; 113729; 113697; 114296; 113587; 113684; 113706; 113003; 112957; 112961; 112962; 112965; 112972; 112974; 112994; 112995; 112999; 113006; 113008; 113010; 113520; 113522; 113525; 113533; 113534; 113536; 113547; 113550; 113555; 113556; 113557; 113561; 113563; 113689; 113724; 114021; 114101; 114105; 114106; 114107; 114109; 114110; 114111; 114116; 114117; 114310; 114333; 114108; 112792; 112798; 114497; 114324; 114325; 114330; 114336; 114493; 114537; 113046; 113662; 113667; 113682; 113591; 113594; 113654; 113655; 113740; 114020; 114030; 114044; 114046; 114048; 114096; 114114; 114019; 114025; 114027; 114033; 114039; 114040; 114045; 114051; 114028; 113704; 113746; 113748; 113753; 113760; 113061; 113725; 113586; 113691; 114307; 114309; 113028; 113066; 113539; 113515; 113709; 114047; 112814; 112824; 112829; 112830; 112844; 112848; 112865; 112866; 112807; 112822; 112823; 112834; 112835; 112847; 112854; 112876; 122848; 113758; 114508; 114951; 114342; 114343; 114346; 114351; 114360; 114500; 114345; 114499; 114505; 112976; 113037; 113040; 113524; 114322; 114498; 114510; 114636; 114640; 114641; 114676; 114685; 114695; 114701; 114820; 114827; 114841; 114900; 114901; 114674; 114725; 114800; 114810; 114812; 114822; 114825; 113057; 113063; 112821; 112839; 112842; 112867; 112826; 112837; 112825; 112982; 112987; 113510; 113511; 113546; 113584; 113592; 113652; 113686; 113710; 113723; 113756; 113671; 113675; 113715; 114009; 114013; 114489; 114494; 113549; 113744; 114637; 114947; 112765; 112766; 112767; 112768; 112770; 112774; 112775; 112776; 112778; 112779; 112780; 112787; 112815; 112841; 112862; 112968; 112977; 113013; 113014; 113016; 113017; 113018; 113027; 113032; 113039; 113050; 113535; 113562; 113588; 113658; 113755; 114032; 114488; 114842; AARC0001; AARC002; AARC003; AARC004; AARC005; AARC006; AARC007; AARC008; AARC009; 114095; 113590;  Catalog Number: PRT-00490-100 GTIN (Primary ID): 00855573007761/00855573007204 Serial Numbers: 112929; 113598; 113233; 113238; 113239; 113241; 113243; 113244; 113245; 113603; 114193; 114201; 114255; 114266;  Catalog Number: PRT-00900-001 GTIN (Primary ID): 00855573007778/00855573007433 Serial Numbers: 113365; 113405; 113906; 113962; 113407; 113414; 113430; 113390; 113437; 113262; 113380; 113458; 113384; 113398; 113442; 113858; 113441; 113443; 113445; 113915; 113817; 113898; 113899; 113378; 113395; 113923; 113972; 113937; 113945; 113957; 113961; 113968; 113368; 113373; 113379; 113264; 113351; 113389; 113370; 113377; 113454; 113468; 113804; 113823; 113830; 113837; 113838; 113881; 113882; 113888; 113892; 113902; 113927; 113967; 113399;  Catalog Number: PRT-00900-100 GTIN (Primary ID): 00855573007785 Serial Numbers: 113096; 113300; 112923; 113107; 112877; 110392; 113143; 113183; 113274; 113323;  Catalog Number: PRT-01098-000 GTIN (Primary ID): 00855573007730 Serial Numbers: 114444; 114451; 114615; 114226; 114442; 114450; 114452; 114441; 114453;  Catalog Number: PRT-01100-000 GTIN (Primary ID): 00855573007747 Serial Numbers: 114556; 114591; 114634; 114771; 114779; 114603; 114606; 114667; 114710; 114713; 114737; 114739; 114559; 114783; 114869; 114576; 114587; 114364; 114369; 114374; 114387; 114391; 114560; 114568; 114764; 114776; 114787; 114849; 114549; 114569; 114705; 114562; 114355; 114372; 114405; 114550; 114594; 114601; 114652; 114659; 114661; 114662; 114358; 114383; 114386; 114389; 114390; 114530; 114540; 114401; 114422; 114424; 114548; 114670; 114714; 114850; 114414; 114417; 114554; 114561; 114861; 114862; 114543; 114786; 114789; 114912; 114917; 114851; 114628; 114211; 114542; 114528; 114531; 114483; 114750; 114643; 114644; 114748; 114926; 114991; 114891; 114892; 114894; 114357; 114409; 114604; 114413; 114653; 114654; 114734; 114754;  Catalog Number: PRT-01100-001 GTIN (Primary ID): 00855573007747 Serial Numbers: 114965; 114966; 114967;
Recalling firm:
Ventec Life Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2021

Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

The HAT trial contains a retaining ring that has shown the potential to disengage during use.

ALL 50 STATES
Full report

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

Recall #:
87989
Lot/product code:
(1) HAT STD Left Tray Trial, Lot #279244001, UDI 10885862541239 ; (2) HAT STD Right Tray Trial, Lot #279244002, UDI 10885862541246 ; (3) HAT LAT Left Tray Trial, Lot #279244017, UDI 10885862541253; (4) HAT LAT Right Tray Trial, Lot #279244004, UDI 10885862541260; (5) HAT EXT LAT Left Trial, Lot #279244005, UDI 10885862541277; and (6) HAT EXT LAT Right Trial, Lot #279244006, UDI 10885862541284.
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 11, 2021

Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg

Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine

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Full report

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

Recall #:
D-0628-2021
Lot/product code:
All Lots
Recalling firm:
DASH XCLUSIVE
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 11, 2021

Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff

ALL 50 STATES
Full report

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

Recall #:
87939
Lot/product code:
Serial Numbers: 1504-314-00-1-0002 up to 2006-314-00-1-0185 ***UPDATED 12/10/21*** Recall expanded to include Rev 3. Complete list of recalled Serial Numbers: 1504-314-00-1-0002 1504-314-00-1-0003 1504-314-00-1-0004 1508-314-00-1-0005 1508-314-00-1-0006 1508-314-00-1-0007 1508-314-00-1-0008 1509-314-00-1-0009 1509-314-00-1-0010 1509-314-00-1-0011 1509-314-00-1-0012 1510-314-00-1-0013 1510-314-00-1-0014 1601-314-00-1-0016 1601-314-00-1-0017 1610-314-00-1-0018 1610-314-00-1-0019 1610-314-00-1-0020 1610-314-00-1-0021 1610-314-00-1-0022 1610-314-00-1-0023 1610-314-00-1-0024 1610-314-00-1-0025 1610-314-00-1-0026 1610-314-00-1-0027 1610-314-00-1-0028 1610-314-00-1-0029 1610-314-00-1-0030 1610-314-00-1-0031 1610-314-00-1-0032 1802-314-00-1-0033 1802-314-00-1-0034 1802-314-00-1-0035 1802-314-00-1-0036 1802-314-00-1-0037 1802-314-00-1-0038 1802-314-00-1-0039 1802-314-00-1-0040 1802-314-00-1-0041 1802-314-00-1-0042 1803-314-00-1-0043 1803-314-00-1-0044 1803-314-00-1-0045 1803-314-00-1-0046 1803-314-00-1-0047 1803-314-00-1-0048 1803-314-00-1-0049 1803-314-00-1-0050 1803-314-00-1-0051 1803-314-00-1-0052 1809-314-00-1-0053 1809-314-00-1-0054 1809-314-00-1-0055 1809-314-00-1-0056 1809-314-00-1-0057 1809-314-00-1-0058 1809-314-00-1-0059 1809-314-00-1-0060 1809-314-00-1-0061 1809-314-00-1-0062 1809-314-00-1-0063 1809-314-00-1-0064 1810-314-00-1-0065 1810-314-00-1-0066 1810-314-00-1-0067 1810-314-00-1-0068 1810-314-00-1-0069 1810-314-00-1-0070 1811-314-00-1-0071 1811-314-00-1-0072 1811-314-00-1-0073 1811-314-00-1-0074 1811-314-00-1-0075 1811-314-00-1-0076 1811-314-00-1-0077 1811-314-00-1-0078 1811-314-00-1-0079 1811-314-00-1-0080 1811-314-00-1-0083 1811-314-00-1-0084 1811-314-00-1-0085 1811-314-00-1-0087 1811-314-00-1-0088 1811-314-00-1-0089 1811-314-00-1-0090 1901-314-00-1-0091 1901-314-00-1-0092 1901-314-00-1-0093 1901-314-00-1-0094 1901-314-00-1-0095 1901-314-00-1-0096 1901-314-00-1-0097 1901-314-00-1-0098 1901-314-00-1-0099 1901-314-00-1-0100 1901-314-00-1-0101 1901-314-00-1-0102 1901-314-00-1-0103 1901-314-00-1-0104 1901-314-00-1-0105 1901-314-00-1-0106 1901-314-00-1-0107 1901-314-00-1-0108 1901-314-00-1-0109 1904-314-00-1-0121 1904-314-00-1-0127 2005-314-00-1-0131 2005-314-00-1-0132 2005-314-00-1-0133 2005-314-00-1-0134 2005-314-00-1-0135 2005-314-00-1-0136 2005-314-00-1-0137 2005-314-00-1-0138 2005-314-00-1-0139 2005-314-00-1-0140 2005-314-00-1-0141 2005-314-00-1-0142 2006-314-00-1-0143 2006-314-00-1-0144 2006-314-00-1-0145 2006-314-00-1-0146 2011-314-00-2-0002 2011-314-00-2-0003 2011-314-00-2-0004 2011-314-00-2-0005 2011-314-00-2-0006 2011-314-00-2-0007 2011-314-00-2-0008 2011-314-00-2-0009 2011-314-00-2-0010 2011-314-00-2-0011 2011-314-00-2-0012 2011-314-00-2-0013 2011-314-00-2-0014 2011-314-00-2-0015 2011-314-00-2-0016 2011-314-00-2-0017 2011-314-00-2-0018 2011-314-00-2-0019 2011-314-00-2-0020 2011-314-00-2-0021 2011-314-00-2-0022 2011-314-00-2-0023 2011-314-00-2-0024 2011-314-00-2-0025 2011-314-00-2-0026 2011-314-00-2-0027 2011-314-00-2-0028 2011-314-00-2-0029 2011-314-00-2-0030 2011-314-00-2-0031 2011-314-00-2-0032 2011-314-00-2-0033 2011-314-00-2-0034 2011-314-00-2-0035 2011-314-00-2-0036 2011-314-00-2-0037 2011-314-00-2-0038 2011-314-00-2-0039 2011-314-00-2-0040 2011-314-00-2-0041 2011-314-00-2-0042 2011-314-00-2-0043 2011-314-00-2-0044 2011-314-00-2-0045 2011-314-00-2-0046 2011-314-00-2-0047 2011-314-00-2-0048 2011-314-00-2-0049 2011-314-00-2-0050 2011-314-00-2-0051 2011-314-00-2-0052 2011-314-00-2-0053 2011-314-00-2-0054 2011-314-00-2-0055 2011-314-00-2-0056 2011-314-00-2-0057 2011-314-00-2-0058 2011-314-00-2-0059 2011-314-00-2-0060 2011-314-00-2-0061 2011-314-00-2-0062 2011-314-00-2-0063 2011-314-00-2-0064 2011-314-00-2-0065 2011-314-00-2-0066 2011-314-00-2-0067 2011-314-00-2-0068 2011-314-00-2-0069 2011-314-00-2-0070 2011-314-00-2-0071 2011-314-00-2-0072 2011-314-00-2-0073 2011-314-00-2-0074 2011-314-00-2-0075 2011-314-00-2-0076 2011-314-00-2-0077 2011-314-00-2-0078 2011-314-00-2-0079 2011-314-00-2-0080 2011-314-00-2-0081 2011-314-00-2-0082 2011-314-00-2-0083 2011-314-00-2-0084 2011-314-00-2-0085 2011-314-00-2-0086 2011-314-00-2-0087 2011-314-00-2-0088 2011-314-00-2-0089 2011-314-00-2-0090 2011-314-00-2-0091 2011-314-00-2-0092 2011-314-00-2-0093 2011-314-00-2-0094 2011-314-00-2-0095 2011-314-00-2-0096 2011-314-00-2-0097 2011-314-00-2-0098 2011-314-00-2-0099 2011-314-00-2-0100 2011-314-00-2-0101 2011-314-00-2-0102 2011-314-00-2-0103 2011-314-00-2-0104 2011-314-00-2-0105 2011-314-00-2-0106 2011-314-00-2-0107 2011-314-00-2-0108 2011-314-00-2-0109 2011-314-00-2-0110 2011-314-00-2-0111 2011-314-00-2-0112 2011-314-00-2-0113 2011-314-00-2-0114 2011-314-00-2-0115 2011-314-00-2-0116 2011-314-00-2-0117 2011-314-00-2-0118 2011-314-00-2-0119 2011-314-00-2-0120 2011-314-00-2-0121 2011-314-00-2-0122 2011-314-00-2-0123 2011-314-00-2-0124 2011-314-00-2-0125 2011-314-00-2-0126 2011-314-00-2-0127 2011-314-00-2-0128 2011-314-00-2-0129 2011-314-00-2-0130 2011-314-00-2-0131 2011-314-00-2-0132 2011-314-00-2-0133 2011-314-00-… (truncated, 5576 characters total — see the official FDA record for the full value)
Recalling firm:
Skytron, Div. The KMW Group, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers: 1202033898 1206032470 1406034563 1607037109   UDI (DI#): 07613327282566
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #3333000000

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  2017000300284  UDI: 07613327322569
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  R52495 R53376 R55047 R56034 M14805 M14885 M14886 M14931 M14936 M14938 M14939 M50074 M50425 M50951 M50956 M54387 R63407 R54523 R54610 R54696 R54698 R60775 R32649 R25384 R35631 R35734 R58735 M15330 R58474  UDI:   07613327169355 07613327169386
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

ALL 50 STATES
Full report

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

Recall #:
88622
Lot/product code:
All Serial numbers
Recalling firm:
CardioQuip, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980

Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.

ALL 50 STATES
Full report

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

Recall #:
87942
Lot/product code:
Lot # 115T1035
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  G201170298 G201181816 G201318385  UDI: 07613327282436
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  FL23J50576 FL23J50577 FL23J60424 FL23J60627 J32346 J32347 J32348 J32350 J29770  UDI: N/A
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  219009000417  UDI: 07613327278453
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  G201179538 UDI: 07613327506129
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  120916611 121016000 130115957 130815166 UDI: 07613327278309
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  U54274 U71491 UDI:07613327169294
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #2710000027

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  111427102713678 UDI:N/A
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  031528600216109 051428600212599 081328600206460 UDI: 07613327298512
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 12, 2021

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC 6 76753 00414 7

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

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-0779-2021
Lot/product code:
Lot No: E372020, "Best Buy": 5/21/2022;
Recalling firm:
Global Sanitizers LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  1911040132 1911040133   UDI: 07613327282665
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  110715076 110915596 110915597 111015378 111015411 110515348 110515556 110517101 110915707 110915708 110915743 111118747 111215214 111216659 111216660 111216671 110717082 110717084 140915228 150615371 100215401  UDI: 07613327278408
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
Serial Numbers:  20170928500311838 UDI: 07613327277852 07613327277937
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

ALL 50 STATES
Full report

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

Recall #:
88199
Lot/product code:
UDI (DI#): 07613327278330
Recalling firm:
Stryker Medical Division of Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 12, 2021

DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.

ALL 50 STATES
Full report

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

Recall #:
87942
Lot/product code:
Lot # 155T1035
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)