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Recalls affecting North Carolina

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

17,306 recalls found
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Just announced

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

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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 Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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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 Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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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 Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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 Sprouts — Robust Radish Mix, 5oz Cups

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

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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

Martina — Mangoes

Potential contamination with Salmonella

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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 August 11, 2021

Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Model: 78135 Serial Number Unique Device Identifier (UDI#) 61019 (01)00884838099715 61028 (01)00884838099715 61001 (01)00884838099715 61004 (01)00884838099715 61023 (01)00884838099715 61008 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61046 (01)00884838099715 61025 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715(21)61041 61007 (01)00884838099715 61014 (01)00884838099715 61018 (01)00884838099715 61000 N/A 61003 (01)00884838099715 61002 N/A 61006 N/A 61009 N/A 61013 N/A 61017 (01)00884838099715(21)61017 61032 (01)00884838099715(21)61032 61015 N/A 61005 (01)00884838099715 61020 (01)00884838099715 61043 (01)00884838099715 61029 (01)00884838099715 61030 (01)00884838099715 61033 (01)00884838099715(21)61033 61052 (01)00884838099715(21)61052 61064 (01)00884838099715(21)61064 61027 (01)00884838099715 61016 (01)00884838099715 61022 (01)00884838099715 61044 (01)00884838099715 61050 (01)00884838099715 61047 (01)00884838099715(21)61047 61053 (01)00884838099715(21)61053 61049 (01)00884838099715(21)61049
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
88726
Lot/product code:
All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
Recalling firm:
Red Medical Supplies
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

ALL 50 STATES
▸Full report

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

Recall #:
88726
Lot/product code:
All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
Recalling firm:
Red Medical Supplies
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

ALL 50 STATES
▸Full report

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

Recall #:
88726
Lot/product code:
All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
Recalling firm:
Red Medical Supplies
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Model: 78137 Serial Number Unique Device Identifier (UDI#) 81045 N/A 81075 (01)00884838068421(21)81075 81076 (01)00884838068421(21)81076 81077 (01)00884838068421(21)81077 81096 (01)00884838068421(21)81096 81124 (01)00884838068421(21)81124 81114 (01)00884838068421(21)81114 81126 (01)00884838068421(21)81126 81125 (01)00884838068421(21)81125 81144 (01)00884838068421(21)81144 81145 (01)00884838068421(21)81145 81159 (01)00884838068421(21)81159 81003 N/A 81111 (01)00884838068421(21)81111 81050 N/A 81051 (01)00884838068421(21)81051 81090 (01)00884838068421(21)81090 81021 N/A 81038 N/A 81185 (01)00884838068421(21)81185 81179 (01)00884838068421(21)81179 81005 N/A 81006 N/A 81011 N/A 81009 N/A 81019 N/A 81020 N/A 81016 N/A 81023 N/A 81017 N/A 81024 N/A 81014 N/A 81018 N/A 81004 N/A 81041 N/A 81057 (01)00884838068421(21)81057 81055 (01)00884838068421(21)81055 81037 (01)00884838068421(21)81037 81049 (01)00884838068421(21)81049 81060 (01)00884838068421(21)81060 81056 (01)00884838068421(21)81056 81064 (01)00884838068421(21)81064 81062 (01)00884838068421(21)81062 81070 (01)00884838068421(21)81070 81078 (01)00884838068421(21)81078 81073 (01)00884838068421(21)81073 81074 (01)00884838068421(21)81074 81112 (01)00884838068421(21)81112 81115 (01)00884838068421(21)81115 81122 (01)00884838068421(21)81122 81147 (01)00884838068421(21)81147 81146 (01)00884838068421(21)81146 81153 (01)00884838068421(21)81153 81156 (01)00884838068421(21)81156 81158 (01)00884838068421(21)81158 81093 (01)00884838068421(21)81093 81027 N/A 81035 N/A 81010 (01)00884838068421(21)81010 81063 (01)00884838068421(21)81063 81028 (01)00884838068421(21)81028 81030 (01)00884838068421(21)81030 81106 (01)00884838068421(21)81106 81052 N/A 81067 (01)00884838068421(21)81067 81105 (01)00884838068421(21)81105 81116 (01)00884838068421(21)81116 81013 N/A 81007 N/A 81008 N/A 81040 N/A 81031 (01)00884838068421(21)81031 81152 (01)00884838068421(21)81152 81044 N/A 81167 (01)00884838068421(21)81167 81170 (01)00884838068421(21)81170 81171 (01)00884838068421(21)81171 81047 (01)00884838068421(21)81047 81059 (01)00884838068421(21)81059 81108 (01)00884838068421(21)81108 81148 (01)00884838068421(21)81148 81133 (01)00884838068421(21)81133 81001 N/A 81086 (01)00884838068421(21)81086 81118 (01)00884838068421(21)81118 81139 (01)00884838068421(21)81139 81140 (01)00884838068421(21)81140 81138 (01)00884838068421(21)81138 81151 (01)00884838068421(21)81151 81175 N/A 81184 N/A 81079 (01)00884838068421(21)81079 81069 (01)00884838068421(21)81069 81061 (01)00884838068421(21)81061 81065 (01)00884838068421(21)81065 81098 (01)00884838068421(21)81098 81085 (01)00884838068421(21)81085 81092 (01)00884838068421(21)81092 81091 (01)00884838068421(21)81091 81032 N/A 81043 (01)00884838068421(21)81043 81026 N/A 81129 (01)00884838068421(21)81129 81131 (01)00884838068421(21)81131 81149 (01)00884838068421(21)81149 81155 (01)00884838068421(21)81155 81162 (01)00884838068421(21)81162 81172 (01)00884838068421(21)81172 81165 (01)00884838068421(21)81165 81180 (01)00884838068421(21)81180 81084 (01)00884838068421(21)81084 81087 (01)00884838068421(21)81087 81088 (01)00884838068421(21)81088 81095 (01)00884838068421(21)81095 81094 (01)00884838068421(21)81094 81100 (01)00884838068421(21)81100 81127 (01)00884838068421(21)81127 81132 (01)00884838068421(21)81132 81174 (01)00884838068421(21)81174 81039 N/A 81071 (01)00884838068421(21)81071 81157 (01)00884838068421(21)81157 81176 (01)00884838068421(21)81176 81117 (01)00884838068421(21)81117 81173 (01)00884838068421(21)81173 81025 N/A 81097 (01)00884838068421(21)81097 81154 (01)00884838068421(21)81154 81015 N/A 81029 N/A 81046 N/A 81033 N/A 81034 N/A 81048 N/A 81042 N/A 81058 (01)00884838068421(21)81058 81080 (01)00884838068421(21)81080 81072 (01)00884838068421(21)81072 81103 (01)00884838068421(21)81103 81113 (01)00884838068421(21)81113 81123 (01)00884838068421(21)81123 81128 (01)00884838068421(21)81128 81137 (01)00884838068421(21)81137 81178 (01)00884838068421(21)81178
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Model: 781261 Serial Number Unique Device Identifier (UDI#) 77008 77000 77004 77007 77003 77001 77002 77018 77016 77019 77010 77014 Model:781262 77131 (01)00884838068445(21)77131 77031 N/A 77046 N/A 77070 N/A 77124 (01)00884838068445(21)77124 77144 (01)00884838068445(21)77144 77172 (01)00884838068445(21)77172 77074 (01)00884838068445(21)77074 77058 N/A 77114 N/A 77127 (01)00884838068445(21)77127 77160 (01)00884838068445(21)77160 77159 (01)00884838068445(21)77159 77182 (01)00884838068445(21)77182 77180 (01)00884838068445(21)77180 77171 (01)00884838068445(21)77171 77179 (01)00884838068445(21)77179 77048 N/A 77040 N/A 77034 N/A 77039 N/A 77035 N/A 77092 N/A 77140 (01)00884838068445(21)77140 77177 (01)00884838068445(21)77177 77181 (01)00884838068445(21)77181 77178 (01)00884838068445(21)77178 77041 N/A 77103 N/A 77193 (01)00884838068445(21)77193 77203 (01)00884838068445(21)77203 77134 (01)00884838068445(21)77134 77047 N/A 77051 N/A 77050 N/A 77060 N/A 77194 (01)00884838068445(21)77194 77111 N/A 77119 (01)00884838068445(21)77119 77167 (01)00884838068445(21)77167 77183 (01)00884838068445(21)77183 77185 (01)00884838068445(21)77185 77187 (01)00884838068445(21)77187 77188 (01)00884838068445(21)77188 77198 (01)00884838068445(21)77198 77195 (01)00884838068445(21)77195 77196 (01)00884838068445(21)77196 77199 N/A 77202 N/A 77037 N/A 77057 N/A 77072 N/A 77075 N/A 77084 N/A 77085 N/A 77078 N/A 77086 N/A 77101 N/A 77110 (01)00884838068445(21)77110 77038 (01)00884838068445(21)77038 77157 (01)00884838068445(21)77157 77156 (01)00884838068445(21)77156 77056 N/A 77052 N/A 77054 N/A 77053 N/A 77055 N/A 77064 N/A 77065 N/A 77067 N/A 77066 N/A 77068 N/A 77069 N/A 77105 N/A 77126 (01)00884838068445(21)77126 77125 (01)00884838068445(21)77125 77137 (01)00884838068445(21)77137 77139 (01)00884838068445(21)77139 77136 (01)00884838068445(21)77136 77135 (01)00884838068445(21)77135 77138 (01)00884838068445(21)77138 77148 (01)00884838068445(21)77148 77141 (01)00884838068445(21)77141 77030 N/A 77033 N/A 77036 N/A 77042 N/A 77044 N/A 77043 N/A 77032 N/A 77049 N/A 77061 N/A 77059 N/A 77071 N/A 77090 N/A 77088 N/A 77093 N/A 77091 N/A 77087 N/A 77097 N/A 77083 N/A 77106 N/A 77112 N/A 77107 (01)00884838068445(21)77107 77115 N/A 77100 (01)00884838068445(21)77100 77118 (01)00884838068445(21)77118 77121 (01)00884838068445(21)77121 77129 (01)00884838068445(21)77129 77120 (01)00884838068445(21)77120 77128 (01)00884838068445(21)77128 77151 (01)00884838068445(21)77151 77143 (01)00884838068445(21)77143 77158 (01)00884838068445(21)77158 77162 (01)00884838068445(21)77162 77161 (01)00884838068445(21)77161 77155 (01)00884838068445(21)77155 77190 (01)00884838068445(21)77190 77191 (01)00884838068445(21)77191 77150 (01)00884838068445(21)77150 77081 N/A 77117 (01)00884838068445(21)77117 77123 (01)00884838068445(21)77123 77166 (01)00884838068445(21)77166 77045 N/A 77063 N/A 77109 N/A 77201 (01)00884838068445(21)77201 77113 N/A 77147 (01)00884838068445(21)77147 77122 (01)00884838068445(21)77122 77154 (01)00884838068445(21)77154 77169 (01)00884838068445(21)77169 77168 (01)00884838068445(21)77168 77130 (01)00884838068445(21)77130 77094 N/A 77062 N/A
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781270

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Serial Number Unique Device Identifier (UDI#) Model: 781270 17536 N/A 24013 N/A 17508 N/A 17212 N/A 38184 (01)00884838095083 17546 N/A 38366 N/A 17290 N/A 34060 N/A 35056 N/A 23011 N/A 38076 N/A 38013 N/A 17369 N/A 17286 N/A 17172 N/A 24025 N/A 35031 N/A 17566 N/A 17490 N/A 17360 N/A 24007 N/A 38199 N/A 35042 N/A 38126 N/A 17302 N/A 17429 (01)00884838095083 24108 N/A 17473 N/A 38317 N/A 35043 N/A 35087 N/A 38040 N/A 17544 N/A 34152 N/A 17204 N/A 17339 N/A 38037 N/A 34032 N/A 23030 N/A 35044 N/A 17416 N/A 17440 N/A 38202 N/A 34145 N/A 38192 N/A 17436 N/A 38038 N/A 17398 N/A 17292 N/A 34211 (01)00884838095083 17264 (01)00884838095083 24055 (01)00884838095083 17415 (01)00884838095083 34142 (01)00884838095083 17283 N/A 38084 N/A 38198 N/A 17386 N/A 17006 N/A 17378 N/A 17533 N/A 38062 (01)00884838095083 35073 (01)00884838095083 34080 N/A 38116 N/A 17583 N/A 38214 N/A 38356 N/A 34111 N/A 35052 N/A 17590 N/A 38235 N/A 34037 N/A 38102 N/A 74011 N/A 38023 N/A 17406 (01)00884838095083 38063 N/A 17265 N/A 24036 N/A 35020 N/A 38135 N/A 17247 N/A 17517 (01)00884838095083(21)17517 34107 N/A 35060 N/A 17524 N/A 17514 N/A 24095 N/A 23026 N/A 24087 N/A 34236 (01)00884838095083 34249 (01)00884838095083 17231 N/A 17222 N/A 17308 N/A 17342 N/A 17388 N/A 17559 N/A 24143 N/A 38005 N/A 38014 N/A 38015 N/A 35048 N/A 38041 N/A 38081 N/A 38168 N/A 17242 N/A 38161 N/A 17245 N/A 38089 N/A 17589 N/A 24124 N/A 17499 N/A 17250 N/A 17468 N/A 24012 N/A 17299 N/A 17564 N/A 17565 N/A 24111 N/A 17493 N/A 17309 N/A 17357 (01)00884838095083 24110 (01)00884838095083 17464 (01)00884838095083 34221 (01)00884838095083 24006 (01)00884838095083 17556 (01)00884838095083 24134 (01)00884838095083 24023 (01)00884838095083 34090 (01)00884838095083 38032 (01)00884838095083 24109 (01)00884838095083 17399 (01)00884838095083(21)17399 34246 (01)00884838095083(21)34246 17594 N/A 24117 N/A 34096 N/A 38006 N/A 38417 N/A 38120 N/A 17495 N/A 38263 N/A 34292 N/A 34154 N/A 34233 N/A 17321 N/A 24090 N/A 17471 N/A 17428 N/A 17458 N/A 17194 N/A 38071 N/A 17246 N/A 38134 N/A 38131 N/A 38026 (01)00884838095083 17550 N/A 17610 N/A 17610 N/A 24145 (01)00884838095083 38217 (01)00884838095083 38225 (01)00884838095083 34250 N/A 17237 N/A 24075 N/A 24018 N/A 17326 N/A 17466 N/A 38138 (01)00884838095083 38111 N/A 17356 (01)00884838095083 38065 N/A 38300 N/A 38259 N/A 38045 N/A 23033 N/A 17239 N/A 34019 N/A 35032 N/A 34098 N/A 24076 N/A 34058 N/A 34223 N/A 17240 N/A 35019 N/A 38091 N/A 17375 N/A 17215 N/A 17459 N/A 24058 N/A 24066 N/A 17516 (01)00884838095083 17284 (01)00884838095083 17366 N/A 17352 N/A
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Serial Number Unique Device Identifier (UDI#) 48026 (01)00884838090057(21)48026 48016 (01)00884838090057(21)48016 48053 (01)00884838090057(21)48053 48003 (01)00884838090057(21)48003 48136 (01)00884838090057(21)48136 48144 (01)00884838090057(21)48144 48020 (01)00884838090057(21)48020 48155 (01)00884838090057(21)48155 48191 (01)00884838090057(21)48191 48216 (01)00884838090057(21)48216 48124 (01)00884838090057(21)48124 48030 (01)00884838090057(21)48030 48011 (01)00884838090057(21)48011 48183 (01)00884838090057(21)48183 48186 (01)00884838090057(21)48186 48187 (01)00884838090057(21)48187 48234 (01)00884838090057(21)48234 48051 (01)00884838090057(21)48051 48000 (01)00884838090057(21)48000 48004 (01)00884838090057(21)48004 48009 (01)00884838090057(21)48009 48005 (01)00884838090057(21)48005 48019 (01)00884838090057(21)48019 48032 (01)00884838090057(21)48032 48132 (01)00884838090057(21)48132 48224 (01)00884838090057(21)48224 48223 (01)00884838090057(21)48223 48207 (01)00884838090057(21)48207 48015 (01)00884838090057(21)48015 48028 N/A 48154 N/A 48160 N/A 48134 N/A 48049 N/A 48031 N/A 48050 N/A 48131 N/A 48040 (01)00884838090057(21)48040 48039 (01)00884838090057(21)48039 48152 (01)00884838090057(21)48152 48173 (01)00884838090057(21)48173 48122 (01)00884838090057(21)48122 48022 (01)00884838090057(21)48022 48012 (01)00884838090057(21)48012 48014 (01)00884838090057(21)48014 48037 (01)00884838090057(21)48037 48036 (01)00884838090057(21)48036 48158 (01)00884838090057(21)48158 48127 (01)00884838090057(21)48127 48044 (01)00884838090057(21)48044 48184 (01)00884838090057(21)48184 48151 (01)00884838090057(21)48151 48174 (01)00884838090057(21)48174 48043 (01)00884838090057(21)48043 48046 (01)00884838090057(21)48046 48055 (01)00884838090057(21)48055 48047 (01)00884838090057(21)48047 48128 (01)00884838090057(21)48128 48129 (01)00884838090057(21)48129 48180 (01)00884838090057(21)48180 48192 (01)00884838090057(21)48192 48194 (01)00884838090057(21)48194 48153 (01)00884838090057(21)48153 48190 (01)00884838090057(21)48190 48226 (01)00884838090057(21)48226 48045 (01)00884838090057(21)48045 48033 N/A 48023 (01)00884838090057(21)48023 48181 (01)00884838090057(21)48181 48200 (01)00884838090057(21)48200 48199 (01)00884838090057(21)48199 48198 N/A 48001 (01)00884838090057(21)48001 48038 (01)00884838090057(21)48038 48167 (01)00884838090057(21)48167 48196 (01)00884838090057(21)48196 48034 (01)00884838090057(21)48034 48035 (01)00884838090057(21)48035 48172 (01)00884838090057(21)48172 48010 (01)00884838090057(21)48010 48027 N/A 48169 (01)00884838090057(21)48169 48182 (01)00884838090057(21)48182 48148 (01)00884838090057(21)48148 48188 (01)00884838090057(21)48188 48018 (01)00884838090057(21)48018 48017 (01)00884838090057(21)48017 48056 (01)00884838090057(21)48056 48112 (01)00884838090057(21)48112 48052 (01)00884838090057(21)48052 48130 (01)00884838090057(21)48130 48013 (01)00884838090057(21)48013 48162 (01)00884838090057(21)48162 48120 (01)00884838090057(21)48120 48171 (01)00884838090057(21)48171 48166 (01)00884838090057(21)48166 48179 (01)00884838090057(21)48179 48214 (01)00884838090057(21)48214 48133 (01)00884838090057(21)48133
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Serial Number Unique Device Identifier (UDI#) Model: 781357 46029 (01)00884838088108(21)46029 46053 (01)00884838088108(21)46053 46045 (01)00884838088108(21)46045 46027 (01)00884838088108(21)46027 46042 (01)00884838088108(21)46042 46084 (01)00884838088108(21)46084 46086 (01)00884838088108(21)46086 46083 (01)00884838088108(21)46083 46030 (01)00884838088108(21)46030 46031 (01)00884838088108(21)46031 46050 (01)00884838088108(21)46050 46049 (01)00884838088108(21)46049 46052 (01)00884838088108(21)46052 46076 (01)00884838088108(21)46076 46085 (01)00884838088108(21)46085 46024 (01)00884838088108(21)46024 46044 N/A 46061 N/A 46001 (01)00884838088108(21)46001 46005 (01)00884838088108(21)46005 46011 (01)00884838088108(21)46011 46012 (01)00884838088108(21)46012 46057 (01)00884838088108(21)46057 46048 (01)00884838088108(21)46048 46021 (01)00884838088108(21)46021 46066 (01)00884838088108(21)46066 46078 (01)00884838088108(21)46078 46081 (01)00884838088108(21)46081 46060 (01)00884838088108(21)46060 46004 (01)00884838088108(21)46004 46018 (01)00884838088108(21)46018 46020 (01)00884838088108(21)46020 46013 (01)00884838088108(21)46013 46015 (01)00884838088108(21)46015 46017 (01)00884838088108(21)46017 46016 (01)00884838088108(21)46016 46023 (01)00884838088108(21)46023 46033 (01)00884838088108(21)46033 46034 (01)00884838088108(21)46034 46037 (01)00884838088108(21)46037 46025 (01)00884838088108(21)46025 46041 (01)00884838088108(21)46041 46026 (01)00884838088108(21)46026 46032 (01)00884838088108(21)46032 46036 (01)00884838088108(21)46036 46059 (01)00884838088108(21)46059 46039 (01)00884838088108(21)46039 46075 (01)00884838088108(21)46075 46046 (01)00884838088108(21)46046 46068 (01)00884838088108(21)46068 46058 (01)00884838088108(21)46058 46054 (01)00884838088108(21)46054 46082 (01)00884838088108(21)46082 46069 (01)00884838088108(21)46069 46003 (01)00884838088108(21)46003 46019 (01)00884838088108(21)46019 46008 (01)00884838088108(21)46008 46007 (01)00884838088108(21)46007 46067 (01)00884838088108(21)46067 46089 N/A 46002 (01)00884838088108(21)46002 46014 (01)00884838088108(21)46014 46065 (01)00884838088108(21)46065 46077 (01)00884838088108(21)46077
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Serial Number Unique Device Identifier (UDI#) Model: 781358 45153 (01)00884838088115(21)45153 45062 (01)00884838088115(21)45062 45107 (01)00884838088115(21)45107 45144 (01)00884838088115(21)45144 45145 (01)00884838088115(21)45145 45142 (01)00884838088115(21)45142 45215 (01)00884838088115(21)45215 45216 (01)00884838088115(21)45216 45284 (01)00884838088115(21)45284 45079 (01)00884838088115(21)45079 45121 (01)00884838088115(21)45121 45007 (01)00884838088115(21)45007 45154 (01)00884838088115(21)45154 45127 (01)00884838088115(21)45127 45052 (01)00884838088115(21)45052 45193 (01)00884838088115(21)45193 45253 (01)00884838088115(21)45253 45042 (01)00884838088115(21)45042 45045 (01)00884838088115(21)45045 45136 (01)00884838088115(21)45136 45119 (01)00884838088115(21)45119 45197 (01)00884838088115(21)45197 45195 (01)00884838088115(21)45195 45097 (01)00884838088115(21)45097 45106 N/A 45131 N/A 45259 (01)00884838088115(21)45259 45300 (01)00884838088115(21)45300 45313 (01)00884838088115(21)45313 45298 (01)00884838088115(21)45298 45265 (01)00884838088115(21)45265 45000 (01)00884838088115 45039 (01)00884838088115(21)45039 45047 (01)00884838088115(21)45047 45080 (01)00884838088115(21)45080 45056 (01)00884838088115(21)45056 45137 (01)00884838088115(21)45137 45129 (01)00884838088115(21)45129 45109 (01)00884838088115(21)45109 45171 (01)00884838088115(21)45171 45205 (01)00884838088115(21)45205 45210 (01)00884838088115(21)45210 45188 (01)00884838088115(21)45188 45297 (01)00884838088115(21)45297 45071 (01)00884838088115(21)45071 45098 (01)00884838088115(21)45098 45140 (01)00884838088115(21)45140 45246 (01)00884838088115(21)45246 45159 (01)00884838088115(21)45159 45031 (01)00884838088115(21)45031 45044 (01)00884838088115(21)45044 45043 (01)00884838088115(21)45043 45040 (01)00884838088115(21)45040 45065 (01)00884838088115(21)45065 45070 (01)00884838088115(21)45070 45260 (01)00884838088115(21)45260 45088 (01)00884838088115(21)45088 45096 (01)00884838088115(21)45096 45128 (01)00884838088115(21)45128 45134 (01)00884838088115(21)45134 45111 (01)00884838088115(21)45111 45190 (01)00884838088115(21)45190 45218 (01)00884838088115(21)45218 45139 (01)00884838088115(21)45139 45241 (01)00884838088115(21)45241 45025 (01)00884838088115(21)45025 45114 (01)00884838088115(21)45114 45151 (01)00884838088115(21)45151 45148 (01)00884838088115(21)45148 45160 (01)00884838088115(21)45160 45176 (01)00884838088115(21)45176 45274 (01)00884838088115(21)45274 45276 (01)00884838088115(21)45276 45282 (01)00884838088115(21)45282 45248 (01)00884838088115(21)45248 45138 (01)00884838088115(21)45138 45295 (01)00884838088115(21)45295 45033 (01)00884838088115(21)45033 45048 (01)00884838088115(21)45048 45037 (01)00884838088115(21)45037 45050 (01)00884838088115(21)45050 45049 (01)00884838088115(21)45049 45046 (01)00884838088115(21)45046 45034 (01)00884838088115(21)45034 45066 (01)00884838088115(21)45066 45061 (01)00884838088115(21)45061 45076 (01)00884838088115(21)45076 45072 (01)00884838088115(21)45072 45077 (01)00884838088115(21)45077 45090 (01)00884838088115(21)45090 45041 (01)00884838088115(21)45041 45091 (01)00884838088115(21)45091 45093 (01)00884838088115(21)45093 45102 (01)00884838088115(21)45102 45105 (01)00884838088115(21)45105 45120 (01)00884838088115(21)45120 45064 (01)00884838088115(21)45064 45084 (01)00884838088115(21)45084 45170 (01)00884838088115(21)45170 45118 (01)00884838088115(21)45118 45163 (01)00884838088115(21)45163 45116 (01)00884838088115(21)45116 45149 (01)00884838088115(21)45149 45141 (01)00884838088115(21)45141 45162 (01)00884838088115(21)45162 45185 (01)00884838088115(21)45185 45115 (01)00884838088115(21)45115 45186 (01)00884838088115(21)45186 45189 (01)00884838088115(21)45189 45211 (01)00884838088115(21)45211 45250 (01)00884838088115(21)45250 45224 (01)00884838088115(21)45224 45272 (01)00884838088115(21)45272 45281 (01)00884838088115(21)45281 45212 (01)00884838088115(21)45212 45231 (01)00884838088115(21)45231 45290 (01)00884838088115(21)45290 45314 (01)00884838088115(21)45314 45323 (01)00884838088115(21)45323 45268 (01)00884838088115(21)45268 45123 (01)00884838088115(21)45123 45122 (01)00884838088115(21)45122 45169 N/A 45168 (01)00884838088115(21)45168 45191 (01)00884838088115(21)45191 45220 (01)00884838088115(21)45220 45204 (01)00884838088115(21)45204 45192 N/A 45229 (01)00884838088115(21)45229 45203 (01)00884838088115(21)45203 45222 (01)00884838088115(21)45222 45228 (01)00884838088115(21)45228 45207 (01)00884838088115(21)45207 45249 (01)00884838088115(21)45249 45279 (01)00884838088115(21)45279 45278 (01)00884838088115(21)45278 45320 (01)00884838088115(21)45320 45156 (01)00884838088115(21)45156 45157 (01)00884838088115(21)45157 45085 (01)00884838088115(21)45085 45303 (01)00884838088115(21)45303 45304 (01)00884838088115(21)45304 45307 (01)00884838088115(21)45307 45305 (01)00884838088115(21)45305 45306 (01)00884838088115(21)45306 45308 (01)00884838088115(21)45308 45309 (01)00884838088115(21)45309 45311 (01)00884838088115(21)45311 45310 (01)008… (truncated, 7592 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

ALL 50 STATES
▸Full report

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

Recall #:
88548
Lot/product code:
N/A
Recalling firm:
Hill-Rom, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Serial Number Unique Device Identifier (UDI#) 8750 N/A 32245 N/A 9013 N/A 8554 N/A 20211 N/A 18801 N/A 8178 N/A 10164 N/A 8752 N/A 10139 N/A 11076 N/A 8156 N/A 8646 N/A 22116 N/A 21175 N/A 8118 N/A 32443 N/A 32444 N/A 32445 N/A 18561 N/A 18761 N/A 30037 N/A 30146 N/A 21748 N/A 20003 N/A 21384 N/A 20116 N/A 20115 N/A 33220 N/A 18746 (01)00884838095076 8074 (01)00884838095076 18853 (01)00884838095076 21349 (01)00884838095076 18986 (01)00884838095076 18943 (01)00884838095076 18583 (01)00884838095076 22144 (01)00884838095076 22266 (01)00884838095076(21)22266 33045 (01)00884838095076(21)33045 32262 (01)00884838095076(21)32262 11100 (01)00884838095076(21)11100 5572 N/A 10236 N/A 12030 N/A 10183 N/A 72077 N/A 8985 N/A 21466 N/A 8240 N/A 32643 N/A 12084 N/A 8260 N/A 8942 N/A 21912 N/A 32180 N/A 21736 N/A 32059 (01)00884838095076 8917 N/A 10087 N/A 8713 N/A 10130 N/A 32621 N/A 18673 N/A 18701 N/A 30067 N/A 21775 (01)00884838095076 21679 N/A 32086 N/A 22220 N/A 8001 N/A 20070 N/A 10717 N/A 39103 N/A 5523 N/A 10511 N/A 10170 N/A 8642 N/A 21033 N/A 11030 N/A 10061 N/A 11031 N/A 8318 N/A 10174 N/A 18665 N/A 8611 N/A 8084 N/A 10191 N/A 8387 N/A 21932 N/A 8025 N/A 18644 N/A 5463 N/A 21142 N/A 8559 N/A 20057 N/A 11102 N/A 18631 N/A 8804 N/A 18565 N/A 5447 N/A 21015 N/A 10075 N/A 11062 N/A 30045 N/A 32176 N/A 8407 N/A 8512 N/A 8021 N/A 32752 N/A 21676 N/A 11001 N/A 18697 N/A 32710 N/A 32438 N/A 21171 N/A 39031 N/A 10033 N/A 5539 N/A 32636 N/A 21392 N/A 8129 N/A 8397 N/A 11108 N/A 11000 N/A 8704 N/A 13082 N/A 10179 N/A 8263 N/A 10523 N/A 32092 N/A 32113 N/A 32341 N/A 32334 N/A 8110 N/A 18957 N/A 8487 N/A 18938 N/A 32454 N/A 12082 N/A 9020 (01)00884838095076 9024 (01)00884838095076 8736 (01)00884838095076 8885 (01)00884838095076 22194 (01)00884838095076 21018 (01)00884838095076 21814 (01)00884838095076 5484 (01)00884838095076 10117 (01)00884838095076 8476 (01)00884838095076 30097 (01)00884838095076 8315 (01)00884838095076 32163 (01)00884838095076 32099 (01)00884838095076 8401 (01)00884838095076 21082 (01)00884838095076 21453 (01)00884838095076 18013 (01)00884838095076 18906 (01)00884838095076 32164 (01)00884838095076 8321 (01)00884838095076 8486 (01)00884838095076 10008 (01)00884838095076 18894 (01)00884838095076 32322 (01)00884838095076 8175 (01)00884838095076 32340 (01)00884838095076 39018 (01)00884838095076 5425 (01)00884838095076(21)5425 8096 (01)00884838095076(21)8096 8010 N/A 8179 N/A 39003 N/A 21003 N/A 8923 N/A 8087 N/A 8601 N/A 8659 N/A 18690 N/A 8215 N/A 32449 N/A 32127 N/A 32467 (01)00884838095076 8427 N/A 10528 (01)00884838095076 10900 N/A 21768 (01)00884838095076 8862 (01)00884838095076 21710 (01)00884838095076 8081 N/A 8485 N/A 8799 N/A 5490 N/A 5479 N/A 21294 N/A 8819 N/A 8967 N/A 8779 N/A 8746 N/A 8200 N/A 10716 N/A 12047 N/A 21477 N/A 8550 (01)00884838095076 21133 (01)00884838095076 21577 (01)00884838095076 32845 (01)00884838095076(21)32845 21050 N/A 21223 N/A 22154 N/A 21554 N/A 32754 N/A 32049 N/A 22070 N/A 72054 N/A 10079 N/A 20198 N/A 8895 N/A 21880 N/A 8884 N/A 21084 N/A 20151 N/A 20152 N/A 21804 N/A 8492 (01)00884838095076 32807 (01)00884838095076 5505 N/A 5499 N/A 8657 (01)00884838095076 32680 (01)00884838095076 32283 (01)00884838095076 10029 N/A 8054 N/A 8350 N/A 21087 N/A 21737 N/A 18940 N/A 32140 N/A 32361 N/A 21184 N/A 33126 N/A 21942 N/A 11072 N/A 21680 N/A 21691 N/A 33051 N/A 22103 N/A 32822 N/A 21694 N/A 18720 N/A 72081 N/A 21141 N/A 33023 (01)00884838095076 21247 (01)00884838095076 18575 (01)00884838095076 0 N/A 30132 (01)00884838095076(21)30132 18718 N/A 32285 (01)00884838095076(21)32285 21363 N/A 13011 N/A 20132 N/A 21032 N/A 22182 N/A 13052 N/A 9022 N/A 8119 N/A 18655 N/A 20111 N/A 32506 N/A 5466 N/A 21343 N/A 22299 N/A 32450 N/A 8786 N/A 8311 N/A 8395 N/A 9004 N/A 5546 N/A 5537 N/A 8712 N/A 8667 N/A 18101 N/A 10044 N/A 8478 N/A 10457 N/A 18511 N/A 10220 N/A 10554 N/A 0 N/A 11046 N/A 32264 N/A 32410 N/A 32492 N/A 18970 N/A 39037 N/A 8840 N/A 10185 N/A 13001 N/A 8365 N/A 72243 N/A 18509 N/A 33100 N/A 8641 N/A 18597 N/A 21623 N/A 18069 N/A 12036 N/A 8251 N/A 18035 N/A 22055 N/A 21011 N/A 32849 N/A 22296 N/A 32990 N/A 21551 N/A 11017 N/A 20164 N/A 8431 N/A 10552 N/A 8330 N/A 20196 N/A 21362 (01)00884838095076 21892 (01)00884838095076 20413 (01)00884838095076 72239 (01)00884838095076 22044 (01)00884838095076 8045 (01)00884838095076 21890 (01)00884838095076 21809 (01)00884838095076(21)21809 32478 (01)00884838095076(21)32478 8591 N/A 13032 N/A 22227 N/A 8012 N/A 8724 N/A 8949 N/A 13073 N/A 20288 N/A 20263 N/A 21482 N/A 5511 N/A 10208 N/A 8481 N/A 8555 N/A 10498 N/A 11042 N/A 8857 N/A 22098 N/A 13062 N/A 21278 N/A 21129 N/A 9007 N/A 11047 N/A 13029 N/A 18038 N/A 12114 N/A 8896 N/A 11091 N/A 13047 N/A 8057 N/A 12055 N/A 20302 N/A 8309 N/A 21560 N/A 21156 N/A 10906 N/A 10513 N/A 21697 N/A 20033 N/A 13046 N/A 10719 N/A 21759 N/A 20319 N/A 8831 N/A 10913 N/A 18060 N/A 10151 N/A 8060 N/A 21062 N/A 20002 N/A 18929 N/A 8531 N/A 11005 N/A 18107 N/A 20195 N/A 20011 N/A 8843 N/A 20237 N/A 21969 N/A 20278 N/A… (truncated, 7462 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056

Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

ALL 50 STATES
▸Full report

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

Recall #:
88548
Lot/product code:
N/A
Recalling firm:
Hill-Rom, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Serial Number Unique Device Identifier (UDI#) Model: 781271 78121 (01)00884838068452(21)78121 78150 (01)00884838068452(21)78150 78157 (01)00884838068452(21)78157 78096 N/A 78208 (01)00884838068452(21)78208 78094 N/A 78012 N/A 78074 N/A 78154 (01)00884838068452(21)78154 78161 N/A 78172 (01)00884838068452(21)78172 78170 (01)00884838068452(21)78170 78182 (01)00884838068452(21)78182 78183 (01)00884838068452(21)78183 78205 (01)00884838068452(21)78205 78196 (01)00884838068452(21)78196 78171 (01)00884838068452(21)78171 78213 (01)00884838068452(21)78213 78221 (01)00884838068452(21)78221 78210 (01)00884838068452(21)78210 78212 (01)00884838068452(21)78212 78233 (01)00884838068452(21)78233 78190 (01)00884838068452(21)78190 78198 (01)00884838068452(21)78198 78216 (01)00884838068452(21)78216 78225 (01)00884838068452(21)78225 78238 N/A 78242 (01)00884838068452(21)78242 78173 (01)00884838068452(21)78173 78251 (01)00884838068452(21)78251 78250 (01)00884838068452(21)78250 78241 (01)00884838068452(21)78241 78235 (01)00884838068452(21)78235 78262 (01)00884838068452(21)78262 78253 (01)00884838068452(21)78253 78244 (01)00884838068452(21)78244 78252 (01)00884838068452(21)78252 78256 (01)00884838068452(21)78256 78263 (01)00884838068452(21)78263 78257 N/A 78266 (01)00884838068452(21)78266 78267 (01)00884838068452(21)78267 78269 (01)00884838068452(21)78269 78265 (01)00884838068452(21)78265 78270 (01)00884838068452(21)78270 78284 (01)00884838068452(21)78284 78281 (01)00884838068452(21)78281 78289 (01)00884838068452(21)78289 78293 (01)00884838068452(21)78293 78271 (01)00884838068452(21)78271 78218 (01)00884838068452(21)78218 78291 (01)00884838068452(21)78291 78283 (01)00884838068452(21)78283 78273 (01)00884838068452(21)78273 78305 (01)00884838068452(21)78305 78268 (01)00884838068452(21)78268 78282 (01)00884838068452(21)78282 78279 (01)00884838068452(21)78279 78292 (01)00884838068452(21)78292 78309 (01)00884838068452(21)78309 78288 (01)00884838068452(21)78288 78314 (01)00884838068452(21)78314 78306 (01)00884838068452(21)78306 78319 (01)00884838068452(21)78319 78320 (01)00884838068452(21)78320 78307 (01)00884838068452(21)78307 78296 (01)00884838068452(21)78296 78280 (01)00884838068452(21)78280 78313 (01)00884838068452(21)78313 78317 (01)00884838068452(21)78317 78321 (01)00884838068452(21)78321 78322 (01)00884838068452(21)78322 78316 (01)00884838068452(21)78316 78310 (01)00884838068452(21)78310 78308 (01)00884838068452(21)78308 78312 (01)00884838068452(21)78312 78240 (01)00884838068452(21)78240 78329 (01)00884838068452(21)78329 78272 (01)00884838068452(21)78272 78189 (01)00884838068452(21)78189 78330 (01)00884838068452(21)78330 78332 (01)00884838068452(21)78332 78334 (01)00884838068452(21)78334 78340 (01)00884838068452(21)78340 78243 (01)00884838068452(21)78243 78294 (01)00884838068452(21)78294 78335 (01)00884838068452(21)78335 78345 (01)00884838068452(21)78345 78295 (01)00884838068452(21)78295 78333 (01)00884838068452(21)78333 78342 (01)00884838068452(21)78342 78341 (01)00884838068452(21)78341 78327 (01)00884838068452(21)78327 78347 (01)00884838068452(21)78347 78224 (01)00884838068452(21)78224 78030 N/A 78036 N/A 78059 N/A 78156 (01)00884838068452(21)78156 78249 (01)00884838068452(21)78249 78080 (01)00884838068452(21)78080 78078 (01)00884838068452(21)78078 78098 (01)00884838068452(21)78098 78003 N/A 78017 N/A 78065 N/A 78070 N/A 78081 N/A 78076 N/A 78087 N/A 78101 (01)00884838068452(21)78101 78097 (01)00884838068452(21)78097 78104 (01)00884838068452(21)78104 78099 (01)00884838068452(21)78099 78107 (01)00884838068452(21)78107 78126 (01)00884838068452(21)78126 78149 (01)00884838068452(21)78149 78151 (01)00884838068452(21)78151 78181 N/A 78219 (01)00884838068452(21)78219 78206 (01)00884838068452(21)78206 78264 (01)00884838068452(21)78264 78063 N/A 78064 N/A 78106 (01)00884838068452(21)78106 78187 (01)00884838068452(21)78187 78000 N/A 78005 N/A 78007 N/A 78009 N/A 78016 N/A 78015 N/A 78018 N/A 78023 N/A 78019 N/A 78021 N/A 78027 N/A 78010 N/A 78029 N/A 78031 N/A 78025 N/A 78033 N/A 78032 N/A 78038 N/A 78035 N/A 78039 N/A 78040 N/A 78045 N/A 78043 N/A 78042 N/A 78049 N/A 78048 N/A 78050 N/A 78051 N/A 78062 N/A 78068 (01)00884838068452(21)78068 78067 N/A 78072 (01)00884838068452(21)78072 78084 N/A 78089 (01)00884838068452(21)78089 78082 N/A 78083 (01)00884838068452(21)78083 78091 (01)00884838068452(21)78091 78095 (01)00884838068452(21)78095 78088 (01)00884838068452(21)78088 78100 (01)00884838068452(21)78100 78111 N/A 78115 (01)00884838068452(21)78115 78117 (01)00884838068452(21)78117 78113 (01)00884838068452(21)78113 78114 (01)00884838068452(21)78114 78109 (01)00884838068452(21)78109 78132 (01)00884838068452(21)78132 78127 (01)00884838068452(21)78127 78133 (01)00884838068452(21)78133 78139 (01)00884838068452(21)78139 78140 (01)00884838068452(21)78140 78129 (01)00884838068452(21)78129 78147 (01)00884838068452(21)78147 78148 (01)00884838068452(21)78148 78145 (01)00884838068452(21)78145 78155 (01)00884838068452(21)78155 78203 (01)00884838068452… (truncated, 7365 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

ALL 50 STATES
▸Full report

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

Recall #:
88548
Lot/product code:
N/A LikoStretch Mod 600 IC, Wide 3156065B UDI: 0887761GMN000036U9
Recalling firm:
Hill-Rom, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

ALL 50 STATES
▸Full report

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

Recall #:
88491
Lot/product code:
Serial Number Unique Device Identifier (UDI#) Model: 781356 47077 (01)00884838090040(21)47077 47194 (01)00884838090040(21)47194 47091 (01)00884838090040(21)47091 47040 (01)00884838090040(21)47040 47092 (01)00884838090040(21)47092 47048 (01)00884838090040(21)47048 47195 N/A 47050 (01)00884838090040(21)47050 47209 (01)00884838090040(21)47209 47247 (01)00884838090040(21)47247 47293 (01)00884838090040(21)47293 47001 (01)00884838090040 47032 (01)00884838090040(21)47032 47041 (01)00884838090040(21)47041 47086 (01)00884838090040(21)47086 47248 (01)00884838090040(21)47248 47255 (01)00884838090040(21)47255 47258 (01)00884838090040(21)47258 47275 (01)00884838090040(21)47275 47002 (01)00884838090040(21)47002 47003 (01)00884838090040(21)47003 47000 (01)00884838090040(21)47000 47017 (01)00884838090040(21)47017 47047 (01)00884838090040(21)47047 47056 (01)00884838090040(21)47056 47035 (01)00884838090040(21)47035 47020 (01)00884838090040(21)47020 47078 (01)00884838090040(21)47078 47089 (01)00884838090040(21)47089 47024 (01)00884838090040(21)47024 47097 (01)00884838090040(21)47097 47225 (01)00884838090040(21)47225 47074 (01)00884838090040(21)47074 47058 (01)00884838090040(21)47058 47192 (01)00884838090040(21)47192 47049 (01)00884838090040(21)47049 47019 (01)00884838090040(21)47019 47012 (01)00884838090040(21)47012 47221 (01)00884838090040(21)47221 47276 (01)00884838090040(21)47276 47297 N/A 47270 (01)00884838090040(21)47270 47197 (01)00884838090040(21)47197 47013 (01)00884838090040(21)47013 47015 (01)00884838090040(21)47015 47053 N/A 47014 N/A 47065 N/A 47082 N/A 47099 N/A 47268 N/A 47009 (01)00884838090040(21)47009 47023 (01)00884838090040(21)47023 47030 (01)00884838090040(21)47030 47080 (01)00884838090040(21)47080 47083 (01)00884838090040(21)47083 47245 (01)00884838090040(21)47245 47215 (01)00884838090040(21)47215 47222 (01)00884838090040(21)47222 47299 (01)00884838090040(21)47299 47227 (01)00884838090040(21)47227 47226 (01)00884838090040(21)47226 47265 (01)00884838090040(21)47265 47284 (01)00884838090040(21)47284 47307 (01)00884838090040(21)47307 47057 (01)00884838090040(21)47057 47075 (01)00884838090040(21)47075 47174 (01)00884838090040(21)47174 47088 (01)00884838090040(21)47088 47175 (01)00884838090040(21)47175 47193 (01)00884838090040(21)47193 47081 (01)00884838090040(21)47081 47188 (01)00884838090040(21)47188 47052 (01)00884838090040(21)47052 47059 (01)00884838090040(21)47059 47085 (01)00884838090040(21)47085 47072 (01)00884838090040(21)47072 47184 (01)00884838090040(21)47184 47187 (01)00884838090040(21)47187 47262 (01)00884838090040(21)47262 47211 (01)00884838090040(21)47211 47252 (01)00884838090040(21)47252 47304 (01)00884838090040(21)47304 47298 (01)00884838090040(21)47298 47094 (01)00884838090040(21)47094 47064 (01)00884838090040(21)47064 47244 (01)00884838090040(21)47244 47219 (01)00884838090040(21)47219 47220 (01)00884838090040(21)47220 47096 (01)00884838090040(21)47096 47190 (01)00884838090040(21)47190 47264 (01)00884838090040(21)47264 47034 (01)00884838090040(21)47034 47202 (01)00884838090040(21)47202 47016 (01)00884838090040(21)47016 47269 (01)00884838090040(21)47269 47271 (01)00884838090040(21)47271 47272 N/A 47004 (01)00884838090040(21)47004 47026 (01)00884838090040(21)47026 47006 (01)00884838090040(21)47006 47007 (01)00884838090040(21)47007 47018 (01)00884838090040(21)47018 47027 (01)00884838090040(21)47027 47011 (01)00884838090040(21)47011 47037 (01)00884838090040(21)47037 47039 (01)00884838090040(21)47039 47029 (01)00884838090040(21)47029 47038 (01)00884838090040(21)47038 47043 (01)00884838090040(21)47043 47054 (01)00884838090040(21)47054 47022 (01)00884838090040(21)47022 47044 (01)00884838090040(21)47044 47028 (01)00884838090040(21)47028 47070 (01)00884838090040(21)47070 47062 (01)00884838090040(21)47062 47033 (01)00884838090040(21)47033 47067 (01)00884838090040(21)47067 47045 (01)00884838090040(21)47045 47060 (01)00884838090040(21)47060 47025 (01)00884838090040(21)47025 47051 (01)00884838090040(21)47051 47063 (01)00884838090040(21)47063 47061 (01)00884838090040(21)47061 47071 (01)00884838090040(21)47071 47066 (01)00884838090040(21)47066 47084 (01)00884838090040(21)47084 47098 (01)00884838090040(21)47098 47095 (01)00884838090040(21)47095 47198 (01)00884838090040(21)47198 47093 (01)00884838090040(21)47093 47177 (01)00884838090040(21)47177 47196 (01)00884838090040(21)47196 47199 (01)00884838090040(21)47199 47203 (01)00884838090040(21)47203 47206 (01)00884838090040(21)47206 47068 (01)00884838090040(21)47068 47183 (01)00884838090040(21)47183 47279 (01)00884838090040(21)47279 47208 (01)00884838090040(21)47208 47260 (01)00884838090040(21)47260 47282 (01)00884838090040(21)47282 47216 (01)00884838090040(21)47216 47185 (01)00884838090040(21)47185 47233 (01)00884838090040(21)47233 47292 (01)00884838090040(21)47292
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2021

EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

ALL 50 STATES
▸Full report

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

Recall #:
88584
Lot/product code:
1) Ecogel 100 Imaging Gel, 250 mL bottle, Print Media Item Number 3541420 (12 each/pack; 72 each/case)  2) Ecogel 100 Imaging Gel, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 3874672 (1 each/pack; 4 each/case)  3) Ecogel 200 Multipurpose Gel BLUE, 250mL bottle, Print Media Item Number 3113545 (12 each/pack, 72 each/case)   4) Ecogel 200 Multipurpose Gel BLUE, Set: 5L jug with 250mL dispenser, Print Media Item Number 1000033 (1 each/pack, 4 each/case)   5) Ecogel 200 Multipurpose Gel CLEAR, 250mL bottle, Print Media Item Number 3158655 (12 each/pack, 72 each/case)   6) Ecogel 200 Multipurpose Gel CLEAR, Set: 5L jug with 250mL dispenser, Print Media Item Number 7565432 (1 each/pack, 4 each/case)  7) Ecolotion Transmission Lotion, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 6115004 (1 each/pack, 4 each/case)
Recalling firm:
AMTEC SALES Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

KEN'S STEAKHOUSE DRESSING ASIAN SESAME DRESSING 4/1gallon Plastic container Ken's Foods Inc Marlborough, MA 01752 MUST BE REFRIGERATED

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-0998-2021
Lot/product code:
All lot codes shipped between 7/14/2021 and 8/13/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

Phillips Majestic Blue Colossal Clawfingers 20/40 6/12 oz CANS UPC 10070057145068 & Phillips Majestic Blue Large Clawfingers 50/70 6/12oz CANS UPC 10070057145167 PASTEURIZED PREMIUM CRAB MEAT WILD CAUGHT KEEP REFRIGERATED

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-0999-2021
Lot/product code:
All lot codes shipped between 7/30/2021 and 8/11/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

MINOR'S SEAFOOD BASE NO MSG GF 6/16 OZ (1 lb) 453 G UNITS Plastic container (pint) gluten free DISTRIBUTED BY NESTLE PROFESSIONAL NORTH AMERIC, SOLON, OH 44139

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-1000-2021
Lot/product code:
All lot codes shipped between 7/14/2021 and 8/13/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

IMPERIAL FRESH POTATO SWEET DICE 1/2, 4/5lbs Plastic overwrap tray

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-0996-2021
Lot/product code:
All lot codes shipped between 7/14/2021 and 8/13/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

GORDO'S AUTHENTIC MEXICAN RESTAURANT STYLE CHEESE DIP NET WT. 5LBS METRIC WT. 1.81 kgs (4/5lbs Plastic tub) KACHWA ENTERPRISES LAKE CITY, GEORGIA 30260 MANUFACTURED BY PLANT NO. 13-370

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-0994-2021
Lot/product code:
All lot codes shipped between 7/14/2021 and 8/13/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

Alfalfa Sprouts 12/4oz Plastic container, sold under the the brand names of: Sunny Creek UPC 7 38015 77740 1 SUNNY CREEK FARM Tryon, NC 28782 and BLOOMSBURY ORGANIC FARMKEEP REFRIGERATED

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-1002-2021
Lot/product code:
All lot codes shipped between 7/14/2021 and 8/13/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

SUNNY CREEK SPROUT BEAN FRESH 1/5lbs Plastic bag

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-1001-2021
Lot/product code:
All lot codes shipped between 7/14/2021 and 8/13/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 13, 2021

FLEISCHMANN'S YEAST COMPRESSED FRESH ESL 24/1lbs Paper/Foil overwrap

The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.

GANCTN
▸Full report

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

Recall #:
F-0993-2021
Lot/product code:
All lot codes shipped between 7/14/2021 and 8/13/2021
Recalling firm:
Sysco Atlanta, LLC
View official FDA record (opens in a new tab)