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Recalls affecting Oklahoma

Data last updated: September 11, 2026 at 1:08 PM UTC

16,641 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)
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

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)
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 January 7, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

ALL 50 STATES
Full report

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

Recall #:
89619
Lot/product code:
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Recalling firm:
Orthosoft, Inc. dba Zimmer CAS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2022

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

ALL 50 STATES
Full report

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

Recall #:
89327
Lot/product code:
All lot numbers within expiry
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080

Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.

ALL 50 STATES
Full report

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

Recall #:
89389
Lot/product code:
Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
Recalling firm:
Compass Health Brands (Corporate Office)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 10, 2022

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

There are lower than expected MICs for some gram negative species.

ALL 50 STATES
Full report

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

Recall #:
89416
Lot/product code:
Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)
Recalling firm:
Remel Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Everest MI XT Inner Dilator, Catalog Number 5101-90167

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

ALL 50 STATES
Full report

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

Recall #:
89522
Lot/product code:
GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Recalling firm:
K2M, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

Everest MI XT Outer Dilator, Catalog Number 5101-90168

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

ALL 50 STATES
Full report

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

Recall #:
89522
Lot/product code:
GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
Recalling firm:
K2M, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 13, 2022

LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

ALL 50 STATES
Full report

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

Recall #:
89539
Lot/product code:
Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling firm:
Lusys Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.

A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.

ALL 50 STATES
Full report

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

Recall #:
89515
Lot/product code:
All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18
Recalling firm:
Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

ALL 50 STATES
Full report

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

Recall #:
89592
Lot/product code:
Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

ALL 50 STATES
Full report

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

Recall #:
89524
Lot/product code:
All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
Recalling firm:
Carl Zeiss Meditec, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2022

Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032

Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling

ALL 50 STATES
Full report

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

Recall #:
89592
Lot/product code:
Lot Numbers: 89648801 89648802 89648803 89648804 89648805 GTIN: 04546540608475 ****UPDATE 3/17/22: Lot Number: 89648802 UDI: " (01)04546540608475(17)261020(10)89648802 Removed from scope of Recall: 89648801 89648803 89648804 89648805
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 14, 2022

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

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-0387-2022
Lot/product code:
Lot #: 32451 Exp. 03/2022; 32532 Exp. 04/2022; 32552 Exp. 05/2022; 32701 32733 Exp. 10/2022; 32855 Exp. 02/2023; 32872 Exp. 03/2023.
Recalling firm:
Mayne Pharma Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2022

OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

ALL 50 STATES
Full report

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

Recall #:
89463
Lot/product code:
HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062
Recalling firm:
Lacrimedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2022

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

ALL 50 STATES
Full report

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

Recall #:
89463
Lot/product code:
CP3 010421-3358 CP3 031419-3125 CP3 032921-3429 CP3 042020-3284 CP3 052219-3149 CP3 061521-3482 CP3 071720-3322 CP3 080218-3045 CP3 091218-3057 CP3 122118-3093 CP4 010621-3377 CP4 022619-3094 CP4 041620-3285 CP4 041719-3126 CP4 072020-3323 CP4 092518-3058 CP5 011221-3359 CP5 033121-3430 CP5 042219-3127 CP5 042220-3286 CP5 072320-3324 CP5 082318-3010 CP5 111418-3059 HP7 103018-3062
Recalling firm:
Lacrimedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2022

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.

The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.

ALL 50 STATES
Full report

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

Recall #:
89499
Lot/product code:
Serial Numbers 550010 550011 550015 550016 550018 550019 550020 550021 550023 550024 550025 550026 550027 550028 550029 550030 550031 550032 550033 550034 550035 550036 550037 550038 550039 550040 550041 550042 550043 550044 550046 550047 550048 550049 550050 550051 550052 550055 550056 550057 550058 550059 550062 550063 550064 550065 550066 550067 550068 550069 550070 550071 550072 550073 550074 550075 550077 550079 550082 550083 550084 550085 550086 550087 550088 550089 550092 550093 550094 550095 550097 550099 550103 550109 550110 550111 550112 550114 550116 550117 550118 550119 550120 550122 550123 550124 550125 550126 550127 550129 550130 550131 550132 550133 550134 550135 550136 550137 550139 550140 550141 550142 550143 550144 550145 550146 550148 550149 550150 550152 550153 550154 550155 550157 550158 550159 550160 550161 550163 550164 550165 550166 550167 550168 550169 550170 550171 550172 550173 550174 550175 550177 550180 550181 550182 550184 550185 550186 550188 550190 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550566 550567 550568 550570 550571 550572 550573 550574 550575 550576 550577 550578 550579 550580 550582 550583 550584 550585 550586 550587 550588 550589 550590 550591 550592 550594 550596 550597 550598 550599 550600 550601 550603 550608 550615 550616 550617 550618 550619 550620 550622 550623 550626 550627 550628 550630 550634 550636 550637 550638 550639 550640 550641 550642 550643 550644 550645 550646 550647 550648 550649 550650 550651 550653 550654 550655 550656 550658 550659 550660 550661 550662 550663 550664 550665 550666 550667 550668 550669 550670 550672 550673 550674 550675 550676 550677 550678 550679 550681 550682 550683 550685 550687 550688 550689 550690 550691 550692 550693 550694 550695 550696 550697 550698 550699 550700 550701 550702 550703 550704 550705 550706 550707 550708 550709 550711 550714 550715 550716 550717 550718 550720 550722 550724 550727 550729 550730 550731 550732 550733 550735 550736 550737 550738 550739 550740 550741 550742 550746 550747 550748 550749 550750 550751 550753 550754 550755 550756 550757 550758 550759 550760 550761 550764 550765 550766 550768 550769 550770 550772 550773 550774 550776 550777 550779 550780 550781 550782 550783 550784 550785 550786 550787 550788 550789 550790 550791 550792 550795 550796 550797 550798 550799 550803 550804 550807 550808 550811 550812 550813 550815 550817 550819 550821 550822 550823 550824 550825 550826 550827 550828 550829 550830 550831 550832 550833 550834 550835 550836 550838 550839 550842 550843 550844 550845 550846 550847 550848 550849 550851 550852 550853 550854 550855 550856 550858 550859 550860 550864 550865 550866 550867 550868 550869 550870 550871 550872 550874 550875 550876 550877 550879 550880 550881 550882 550883 550884 550888 550889 550890 550891 550892 550893 550894 550895 550896 550898 550899 550900 550901 550902 550904 550905 550906 550908 550909 550911 550912 550913 550914 550916 550917 550918 550919 550920 550922 550924 550925 550926 550927 550928 550929 550930 550932 550933 550934 5… (truncated, 19936 characters total — see the official FDA record for the full value)
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)