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Recalls affecting Missouri

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

16,966 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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

Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 9/2/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 9/2/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Microsurgical Operating Room Tables;7300B (18-350-70);

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

Full report

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

Recall #:
85442
Lot/product code:
MUC-20168-0001, MUC-20168-0002, MUC-20171-0003, MUC-20171-0004, MUC-20173-0005, MUC-20173-0006, MUC-20178-0007 & MUC-20178-0008
Recalling firm:
Mizuho America, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 10/20/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 12/18/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 12/18/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Respironics V680 Ventilator, Service # 850011, (OUS Only)

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

ALL 50 STATES
Full report

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

Recall #:
83980
Lot/product code:
Serial Numbers: 100255874, 100255957, 100257487, 100257488, 100257490, 100257491, 100257493, 100257494, 100257495, 100257496, 100257497, 100257498, 100257499, 100257500, 100257501, 100258060, 100258061, 100258063, 100258064, 100258065, 100258066, 100258067, 100258068, 100260220, 100260221, 100260222, 100260223, 100260224, 100260227, 100260228, 100260229, 100260616, 100260617, 100260618, 100260619, 100260620, 100260621, 100260622, 100260623, 100260624, 100260625, 100260626, 100260627, 100260628, 100260629, 100260630, 100260631, 100260632, 100260633, 100260634, 100260635, 100261843, 100261844, 100261845, 100261846, 100261847, 100261848, 100261849, 100261850, 100261851, 100261852, 100261853, 100261854, 100261855, 100261856, 100261857, 100261900, 100261901, 100261902, 100263992, 100263993, 100263994, 100263995, 100263996, 100263997, 100263998, 100263999, 100264020, 100264021, 100264022, 100264023, 100264024, 100264025, 100264026, 100264279, 100264300, 100264301, 100264302, 100264303, 100264561, 100264562, 100264563, 100264564, 100264565, 100264566, 100264567, 100264568, 100264569, 100264570, 100264571, 100264572, 100264573, 100264574, 100264575, 100264576, 100264577, 100264578, 100264579, 100264780, 100264781, 100264782, 100264783, 100264784, 100264785, 100265624, 100265625, 100265626, 100265627, 100265628, 100265629, 100265630, 100265631, 100265632, 100265633, 100265634, 100265635, 100265636, 100265637, 100265638, 100265639, 100265640, 100265641, 100265642, 201034917, 201034918, 201034919, 201034945, 201034946, 201034947, 201034949, 201034950, 201034951, 201034952, 201034953, 201034954, 201035015, 201035016, 201035017, 201035018, 201035019, 201035080, 201035081, 201035082, 201035083, 201035084, 201035085, 201035197, 201035198, 201035199, 201035221, 201035222, 201035223, 201035224, 201035225, 201035226, 201035320, 201035321, 201035322, 201035323, 201035324, 201035325, 201035326, 201035328, 201035329, 201035330, 201035331, 201035332, 201035333, 201035334, 201035335, 201035336, 201035337, 201035338, 201035339, 201035360, 201035361, 201035362, 201035363, 201035364, 201035365
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 12, 2019

Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

ALL 50 STATES
Full report

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

Recall #:
83826
Lot/product code:
Lot number: 494604
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 13, 2019

The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

ALL 50 STATES
Full report

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

Recall #:
83889
Lot/product code:
Software version VG4.1.1/VG4.0.3 and lower
Recalling firm:
Draegar Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

ALL 50 STATES
Full report

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

Recall #:
84043
Lot/product code:
UDI: 05055845400282; Lot Numbers 902924530, 902925703
Recalling firm:
Axis-Shield Diagnostics, Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)

Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

ALL 50 STATES
Full report

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

Recall #:
92945
Lot/product code:
UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Recalling firm:
Icecure Medical Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

ALL 50 STATES
Full report

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

Recall #:
84595
Lot/product code:
Lot number(s) : 18G0037
Recalling firm:
Medicrea International
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

ALL 50 STATES
Full report

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

Recall #:
84043
Lot/product code:
UDI: 05055845400183; Lot Number 902924815
Recalling firm:
Axis-Shield Diagnostics, Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

ALL 50 STATES
Full report

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

Recall #:
84595
Lot/product code:
Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038
Recalling firm:
Medicrea International
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Alinity ci Level Sensor, Bulk Solution

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

ALL 50 STATES
Full report

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

Recall #:
83847
Lot/product code:
List Number 04S68-02, All Serial Numbers
Recalling firm:
Abbott Gmbh & Co. KG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

ALL 50 STATES
Full report

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

Recall #:
83847
Lot/product code:
List Number 03R66 03, All Serial Numbers
Recalling firm:
Abbott Gmbh & Co. KG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

ALL 50 STATES
Full report

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

Recall #:
83847
Lot/product code:
List Number 03R69 03 & 03R69 04, All Serial Numbers
Recalling firm:
Abbott Gmbh & Co. KG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 16, 2019

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

ALL 50 STATES
Full report

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

Recall #:
84043
Lot/product code:
UDI: 05055845400169; Lot Number 902924526
Recalling firm:
Axis-Shield Diagnostics, Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 18, 2019

iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.

ALL 50 STATES
Full report

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

Recall #:
85271
Lot/product code:
Polaris 2.10 software version (disk batch 629774); iLab Polaris Systems affected product listing (serial numbers): 200204, 200209, 200217, 200308, 200310, 200448, 200450, 200456, 200457, 200458, 200461,200480, 200481, 200103, 200145, 200044, 200118, 200360, 200498, 200170, 8361, 10312, 10443, 10548, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278,10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508, 8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 6582 , 7023, 7857, 5637, 5716, 6650, 6894, 4031, 5003, 5043, 5060, 5109, 5232, 5239, 5393, 5465, 5651, 5678, 5860, 6193, 6350, 8264, 6819, 6921, 6934, 7332, 7341, 7362, 7733, 7828, 7858, 7933, 7934, 8011, 8155, 8290, 6383, 5182, 5219, 5296, 5398, 8157, 6760, 7723, 10108, 8365, 8367, 10504, 10657, 10501, 4274, 8046, 8048, 5892, 7818, 4773, 5585, 8113, 5165, 4402, 6468, 6319, 5313, 7511, 4952, 5277, 5457, 4116, 5403, 5078, 5664, 5666, 6327, 6733, 6994, 6136, 6206, 6172, 7604, 7602, 7353, 6273, 6993, 4045, 10221, 10261, and 8540.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 19, 2019

Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

Full report

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

Recall #:
83869
Lot/product code:
All serial numbers sold between 02/06/2016 - 04/30/2019
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 19, 2019

Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260

Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.

Full report

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

Recall #:
83869
Lot/product code:
All serial numbers distributed between 02/06/16 - 04/30/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 19, 2019

Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

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-0121-2020
Lot/product code:
Lot 4DU2E009
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 19, 2019

Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

Full report

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

Recall #:
83869
Lot/product code:
All serial numbers sold between 01/21/2015 - 04/30/2019
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 19, 2019

Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

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-0124-2020
Lot/product code:
Lot 4P04D007
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 19, 2019

Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

Full report

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

Recall #:
83869
Lot/product code:
All serial numbers sold between 10/24/2014 - 04/30/2019
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)