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Recalls affecting South Dakota

Data last updated: September 9, 2026 at 1:18 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.

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 July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT75X Lot #: TS19060031, TS19060065, TS19060168, TS19060302, TS19080080, TS19080176, TS19080203, TS19080262, TS19090027, TS19090064, TS19090167, TS19090272, TS19100111, TS19100197, TS19100244, TS19100262, TS19110041, TS19110102, TS19110176, TS19110238, TS19120002, TS19120044, TS19120274, TS20020286, TS20030288, TS20040030, TS20040086, TS20050114  Additional Affected Lots as of 10/20/20: TS20040051, TS20040075, TS20040058, TS20040176, TS20040280, TS20040281, TS20040291, TS20050010, TS20050174, TS20050306, TS20050353, TS20060032, TS20060038, TS20060120, TS20060174, TS20060175, TS20060260, TS20050250
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT70X Lot #: TS19060339, TS19070029, TS19070108, TS19070180, TS19070285, TS19080035, TS19080064, TS19080140, TS19080186, TS19080271, TS19090054, TS19090149, TS19090266, TS19100058, TS19100107, TS19100186, TS19100308, TS19110038, TS19110090, TS19110157, TS19110225, TS19120005, TS20030299, TS20040046  Additional Affected Lots as of 10/20/20: TS20040204, TS20040260, TS20040312, TS20050113, TS20050157, TS20050289, TS20050290, TS20050391, TS20060093, TS20060152, TS20060153, TS20060204, TS20060237, TS20060238, TS20060296, TS20060304, TS20060305, TS20070020, TS20070107
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT65X Lot #: TS19060064, TS19060158, TS19060303, TS19060393, TS19070019, TS19070068, TS19070138, TS19070185, TS19070297, TS19080022, TS19080051, TS19080128, TS19080134, TS19080239, TS19080326, TS19090058, TS19090104, TS19090212, TS19090295, TS19100043, TS19100138, TS19100173, TS19100310, TS19110023, TS19110083, TS19110150, TS19110211, TS19110349, TS20020024, TS20020262, TS20030066, TS20030179, TS20030219, TS20030318, TS20040116  Additional Affected Lots as of 10/20/20: TS20040111, TS20040069, TS20040104, TS20040174, TS20040293, TS20050140, TS20050181, TS20050182, TS20050268, TS20050269, TS20050336, TS20050344, TS20050378, TS20060010,TS20060064, TS20060065, TS20060138, TS20060140, TS20060224, TS20060225, TS20060285, TS20060286, TS20070003, TS20070081  Additional Affected Lots as of 2/23/21: TS20070179
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.

ALL 50 STATES
Full report

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

Recall #:
86249
Lot/product code:
Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621"
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092  Additional Affected lots as of 10/20/20: TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT85X Lot #: TS19060044, TS19060122, TS19060189, TS19080111, TS19080184, TS19080227, TS19090008, TS19090127, TS19100079, TS19100220, TS19110109, TS19110285, TS19110331, TS19120316, TS20050031, TS20050139  Additional Affected Lots as of 10/20/20: TS20050169, TS20050262, TS20060005
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT60X Lot #: TS19060043, TS19060123, TS19060199, TS19070005, TS19070027, TS19070067, TS19070130, TS19070179, TS19070273, TS19080030, TS19090067, TS19090158, TS19090226, TS19090289, TS19110333, TS19120019, TS19120322, TS20020121, TS20030015, TS20030324  Additional Affected Lots as of 10/20/20: TS20040173, TS20040249, TS20040257, TS20040333, TS20050052, TS20050069, TS20050152, TS20050153, TS20050196, TS20050197, TS20050334, TS20050335, TS20060011, TS20060053, TS20060054, TS20060115, TS20060116, TS20060199, TS20060200, TS20060250, TS20070023, TS20070108, TS20070183
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2020

PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

ALL 50 STATES
Full report

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

Recall #:
86131
Lot/product code:
Item Code: 2D72NT80X Lot #: TS19060095, TS19060169, TS19060328, TS19060357, TS19070100, TS19080183, TS19080225, TS19080308, TS19090043, TS19090188, TS19090292, TS19100150, TS19100214, TS19100282, TS19110050, TS19110115, TS19110295, TS19110334, TS19120049, TS20050165  Additional Affected Lots as of 10/20/20: TS20040334, TS20040358, TS20040359, TS20050106, TS20050322, TS20060026, TS20060084
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product 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-0081-2021
Lot/product code:
1931101AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product 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-0079-2021
Lot/product code:
1931104AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product 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-0080-2021
Lot/product code:
1931102AL
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product 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-0078-2021
Lot/product code:
all lots
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 30, 2020

NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product 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-0082-2021
Lot/product code:
Lots ending in 1001,1002, 1003, 1004, 1005.
Recalling firm:
Albek De Mexico S.A. De C.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 31, 2020

PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8).

ALL 50 STATES
Full report

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

Recall #:
86211
Lot/product code:
All 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(truncated, 138716 characters total — see the official FDA record for the full value)
Recalling firm:
MicroPort Orthopedics Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 3, 2020

DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.

There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.

ALL 50 STATES
Full report

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

Recall #:
86257
Lot/product code:
Model/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01
Recalling firm:
Encore Medical, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 3, 2020

Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.

The products were improperly heat treated.

Full report

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

Recall #:
86187
Lot/product code:
Lot Numbers: 18DM14901, 18FM21215, 18DM07309, 18GM20885, 19EM21519, 18JM05681, 19EM21520
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.

Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.

ALL 50 STATES
Full report

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

Recall #:
85962
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.

Infusion pump component defect may result in interruption of patient monitoring

ALL 50 STATES
Full report

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

Recall #:
85997
Lot/product code:
Model: EtCO2 8300; Lot/Serial numbers: 10002682711,  10002720508, 1000287042, 10002882569
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Full report

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

Recall #:
85900
Lot/product code:
All kits manufactured from April 07, 2017 to Present.
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

Alaris System PC Unit Model 8015

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Full report

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

Recall #:
85900
Lot/product code:
All serial numbers manufactured from April 07, 2017 to Present.
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 4, 2020

BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

Full report

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

Recall #:
86005
Lot/product code:
Device Model/Serial Number: Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652: All Kits; PCA Module Model 8120: PCA (8120) 14217746 PCA (8120) 14259835 PCA (8120) 13063333 PCA (8120) 14231894 PCA (8120) 14231522 PCA (8120) 14232093 PCA (8120) 14373709 PCA (8120) 12334465 PCA (8120) 13638955 PCA (8120) 13638959 PCA (8120) 14231764 PCA (8120) 14232010 PCA (8120) 14567433 PCA (8120) 14231895 PCA (8120) 14217150 PCA (8120) 14217736 PCA (8120) 14217764 PCA (8120) 14218525 PCA (8120) 14218830 PCA (8120) 14217763 PCA (8120) 13406723 PCA (8120) 13078712 PCA (8120) 13081384 PCA (8120) 13096518 PCA (8120) 13096520 PCA (8120) 13096532 PCA (8120) 13096538 PCA (8120) 13096800 PCA (8120) 13096812 PCA (8120) 13096814 PCA (8120) 13096944 PCA (8120) 13097130 PCA (8120) 13097157 PCA (8120) 13113383 PCA (8120) 13113468 PCA (8120) 13134042 PCA (8120) 13134073 PCA (8120) 13134172 PCA (8120) 13134186 PCA (8120) 13134230 PCA (8120) 13134323 PCA (8120) 14015426 PCA (8120) 14015566 PCA (8120) 14219103 PCA (8120) 14216794 PCA (8120) 14217593 PCA (8120) 14218526 PCA (8120) 14219469 PCA (8120) 13919809 PCA (8120) 13919202 PCA (8120) 13919567 PCA (8120) 13919591 PCA (8120) 13919328 PCA (8120) 13919810 PCA (8120) 13875008 PCA (8120) 13875021 PCA (8120) 13875207 PCA (8120) 13875293 PCA (8120) 13875611 PCA (8120) 13875635 PCA (8120) 13919066 PCA (8120) 13919219 PCA (8120) 13919239 PCA (8120) 13919278 PCA (8120) 13919281 PCA (8120) 13919365 PCA (8120) 13919431 PCA (8120) 13919444 PCA (8120) 13919462 PCA (8120) 13919467 PCA (8120) 13919556 PCA (8120) 13919574 PCA (8120) 13919589 PCA (8120) 13919613 PCA (8120) 13919614 PCA (8120) 13919615 PCA (8120) 13919626 PCA (8120) 13919641 PCA (8120) 13919721 PCA (8120) 13919723 PCA (8120) 13919769 PCA (8120) 13919776 PCA (8120) 13919777 PCA (8120) 13919778 PCA (8120) 13919811 PCA (8120) 13919833 PCA (8120) 13919834 PCA (8120) 13919927 PCA (8120) 13919928 PCA (8120) 13919780 PCA (8120) 13919448 PCA (8120) 13919378 PCA (8120) 13919445 PCA (8120) 13875499 PCA (8120) 13875181 PCA (8120) 13919463 PCA (8120) 13875484 PCA (8120) 13919283 PCA (8120) 13919768 PCA (8120) 13919742 PCA (8120) 13918879 PCA (8120) 13918765 PCA (8120) 13919419 PCA (8120) 13875454 PCA (8120) 13919363 PCA (8120) 13919069 PCA (8120) 13919779 PCA (8120) 13919726 PCA (8120) 13595964 PCA (8120) 15939612 PCA (8120) 15939491 PCA (8120) 15939540 PCA (8120) 15943034 PCA (8120) 15943030 PCA (8120) 15939588 PCA (8120) 15939561 PCA (8120) 15939562 PCA (8120) 15939521 PCA (8120) 15960206 PCA (8120) 15960188 PCA (8120) 15960093 PCA (8120) 15960051 PCA (8120) 15939610 PCA (8120) 15939523 PCA (8120) 15960253 PCA (8120) 15939522 PCA (8120) 15943690 PCA (8120) 15943693 PCA (8120) 15943503 PCA (8120) 15944032 PCA (8120) 15944036 PCA (8120) 15943694 PCA (8120) 15944039 PCA (8120) 15943559 PCA (8120) 15943691 PCA (8120) 16097240 PCA (8120) 16097238 PCA (8120) 16097249 PCA (8120) 16097449 PCA (8120) 15952783 PCA (8120) 15952707 PCA (8120) 15952694 PCA (8120) 15952730 PCA (8120) 15952697 PCA (8120) 15952807 PCA (8120) 15952699 PCA (8120) 15952705 PCA (8120) 14985338 PCA (8120) 16087046 PCA (8120) 16087051 PCA (8120) 16087058 PCA (8120) 16087077 PCA (8120) 16087107 PCA (8120) 15943699 PCA (8120) 15943707 PCA (8120) 15952689 PCA (8120) 15952704 PCA (8120) 15952706 PCA (8120) 15952708 PCA (8120) 15952757 PCA (8120) 16094953 PCA (8120) 16094959 PCA (8120) 16094961 PCA (8120) 16094976 PCA (8120) 16094978 PCA (8120) 15939514 PCA (8120) 15939515 PCA (8120) 15939539 PCA (8120) 15939609 PCA (8120) 15939611 PCA (8120) 15959499 PCA (8120) 15959516 PCA (8120) 15960126 PCA (8120) 14961137 PCA (8120) 15960078 PCA (8120) 15960139 PCA (8120) 15959572 PCA (8120) 15960137 PCA (8120) 15960062 PCA (8120) 15959729 PCA (8120) 15960103 PCA (8120) 15960118 PCA (8120) 15960119 PCA (8120) 15973938 PCA (8120) 15973865 PCA (8120) 15973940 PCA (8120) 15973910 PCA (8120) 15973866 PCA (8120) 15974058 PCA (8120) 15973453 PCA (8120) 16051471 PCA (8120) 16051408 PCA (8120) 16051466 PCA (8120) 16051404 PCA (8120) 16073302 PCA (8120) 16051372 PCA (8120) 16051474 PCA (8120) 16073289 PCA (8120) 16073290 PCA (8120) 16051452 PCA (8120) 16051478 PCA (8120) 16073292 PCA (8120) 16051379 PCA (8120) 16073286 PCA (8120) 16073288 PCA (8120) 16051443 PCA (8120) 16051468 PCA (8120) 16051469 PCA (8120) 16051403 PCA (8120) 16051465 PCA (8120) 16073305 PCA (8120) 16073287 PCA (8120) 16051401 PCA (8120) 15111989 PCA (8120) 16057070 PCA (8120) 16057106 PCA (8120) 16055273 PCA (8120) 16055274 PCA (8120) 16057075 PCA (8120) 16057083 PCA (8120) 16097243 PCA (8120) 16097446 PCA (8120) 16097447 PCA (8120) 16097448 PCA (8120) 16097450 PCA (8120) 16097451 PCA (8120) 16097452 PCA (8120) 16097466 PCA (8120) 16097480 PCA (8120) 16097487 PCA (8120) 15959561 PCA (8120) 15959649 PCA (8120) 15959663 PCA (8120) 15959671 PCA (8120) 15959739 PCA (8120) 15960070 PCA (8120) 15960125 PCA (8120) 15960148 PCA (8120) 15960175 PCA (8120) 15960210 PCA (8120) 15973432 PCA (8120) 15973450 PCA (8120) 15973854 PCA (8120) 15973… (truncated, 3670361 characters total — see the official FDA record for the full value)
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 3000162, 300163, 300174, 300176
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 600229, 600230, 600232, 600271, 600282
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2020

Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

ALL 50 STATES
Full report

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

Recall #:
86269
Lot/product code:
Serial Numbers: 353020, 353021, 353023, 353045, 353049
Recalling firm:
Shanghai United Imaging Healthcare Co., Ltd.
View official FDA record (opens in a new tab)