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Recalls affecting Utah

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

16,633 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)

▸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

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 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 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

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 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.

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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)
UnclassifiedRisk not yet known
Medical deviceRecalled August 13, 2021

Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.

There is a potential for distal end of catheters to fracture and become detached.

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

Recall #:
88611
Lot/product code:
Affected Lots: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001
Recalling firm:
IMPERATIVE CARE INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 13, 2021

Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

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

Recall #:
D-0811-2021
Lot/product code:
Lots 00019431, 00019542, 00019543, 00019544, 00020814, 00020815, 00020907, 00020965, 00021421, 00021422, 00021423, 00022136, 00022174, 00022175, 00022176, 00022177, 00022765, 00022766, 00023134, 00023135, 00023747, 00023748, DL3896, DL7779, DR2614, DX4576, DX5870, DX5871, DX5872, DX5873, DX7805, DY6078, DY7060, DY9367, DY9473, DY9475, DY9476, DY9505, EC5910, EC5913, EE9391, EF2346, EM4805, EM4807, EN2005, ET1601, ET1605, ET1606 EXPIRATION DATE: September 2021 December 2023
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 13, 2021

Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

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▸Full report

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

Recall #:
D-0809-2021
Lot/product code:
Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 13, 2021

Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

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▸Full report

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

Recall #:
D-0808-2021
Lot/product code:
Lots 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611 EXPIRATION DATE: August 2021 January 2023
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 13, 2021

Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

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▸Full report

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

Recall #:
D-0810-2021
Lot/product code:
Lots 00018777, 00019289, 00019593, 00019682, 00019846, 00019977, 00020295, 00020448, 00020458, 00020480, 00021024, 00021073, 00021074, CW1565, CW1566, CW1567, CW1568, CW1569, CW1570, CW1571, CW1572, CW1573, CW1574, CW1575, CW1578, CW1579, CW1581, DF5277, DF5278, DF5279, DF5280, DF5281, DF5282, DR5086, DR5092, DR5093, DR5094, DT3885, DW4148, DW4152, DY7987, EC9841, EC9842, EC9847, EC9848, EE1011, EM1069, EM1070, EN5694, EN5695, EP1717, EP1718, EP1719, EW2012, EW3854, EW3865, EX2102, EX2103 EXPIRATION DATE: September 2021 December 2023
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 16, 2021

syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

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▸Full report

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

Recall #:
88588
Lot/product code:
Serial Numbers: 128051 130051 128065 128035 130057 128086 128079 128041 128019 128078 128060 128068 112045 128085 128075 128022 128033 130012 128016 130044 130048 130049 128018 119216 108085 128015 130019 130055 130054 128020 128039 130052 130036 130061 128049 117756 128029 130021 130045 130039 128063 128057 128045 128046 ***UPDATED 12/9/21*** 128114 128113 130058 ***Updated 1/31/22: Serial Number 128123 130015 130081 112261 112071 128124 128132 128125 130079 130077 Expanded Recall 3/12/22: 11061620 S/N: 111805 11061660 S/N: 128144, 128135, 128142, 128136, 128133 11061670 S/N: 130088, 130094, 130090, 130087, 130091, 130092, 130089
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 16, 2021

syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

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▸Full report

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

Recall #:
88588
Lot/product code:
Serial Numbers: 100713 223736 222946 223440 223032 223347 223084 223811 130643 223004 451078 101724 132011 131247 451036 132231 451032 222835 130848 500010 101773 132729 130874 133176 100421 100419 100420 100643 100642 100811 100814 100644 102369 100812 100641 100418 100813 100645 131284 130712 223734 102305 132893 223310 222411 223258 223334 223090 132781 131867 222563 222417 222491 131503 130125 451070 222224 132108 500013 132061 131169 451023 451017 451077 132701 102113 451094 130628 500007 131213 131360 500020 500028 451079 132205 451031 451001 222914 130331 451034 133191 102108 132136 131325 222686 223207 130734 102021 131578 500005 451071 222521 132904 102031 222539 222860 451039 130335 222862 222638 100677 222729 131336 223188 130452 223220 131801 131589 222719 132102 130140 223844 500004 451074 451030 133198 222601 133261 132595 130751 223150 131966 223424 223259 223058 131012 ***Updated 12/9/21*** 223021 ***Updated 1/31/22: Serial number 222475 133503
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 16, 2021

MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815

Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

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▸Full report

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

Recall #:
88588
Lot/product code:
Serial Numbers: 176302 175681
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 18, 2021

Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue

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

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▸Full report

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

Recall #:
88751
Lot/product code:
Item Number: 663 0061, all lots bearing old style logo. Older logo states that product was manufactured by Eco-Med Pharmaceuticals in Canada.
Recalling firm:
Scrip Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 18, 2021

Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows, resulting in delay in diagnosis or scan aborts with the necessity for patient rescan may occur

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

Recall #:
88581
Lot/product code:
US Serial Numbers: 111307, 111526, 119328, 108158, 123104, 111219, 123054, 117633, 111566, 111427, 123059, 117558, 117533, 119317, 117647, 108088, 123060, 123118, 123055, 111518, 123113, 108108, 123129, 123122, 123069, 111507, 111560, 119142, 108111, 108062, 119376. Update CT016/21/S is a remote update for the following products with software versions syngo CT VA30A SP2 or syngo CT VA30A SP2a or syngo CT VA30A SP3: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648), SOMATOM go.Sim (Model #11061660, #11061668), SOMATOM go.Open Pro (Model #11061670, #11061678). Update CT018/21/S is a remote update for the following products with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Now (Model #11061610, #11061612, #11061613, #11061618), SOMATOM go.Up (Model #11061620, #11061622, #11061623, #11061628), SOMATOM go.All (Model #11061630, #11061632, #11061638), SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT022/21/S is an onsite update for the following product with software versions syngo.CT VA20A_SP4a or syngo.CT VA20A_SP5: SOMATOM go.Top (Model #11061640, #11061642, #11061648) without dual energy post-processing. Update CT025/21/S is an onsite update for the following product with software versions syngo.CT VA30A_SP2, VA30A_SP2a, syngo CT VA30A_SP3, or syngo CT VA30A_FP2 : SOMATOM X.cite (Model #11330001)
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 18, 2021

Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue

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

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▸Full report

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

Recall #:
88751
Lot/product code:
Item Number: 663 0019, all lots distributed between August 2018 and August 2021
Recalling firm:
Scrip Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled August 18, 2021

X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0819-2021
Lot/product code:
All lots, Exp. 12/2025
Recalling firm:
Phe Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2021

P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

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▸Full report

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

Recall #:
88628
Lot/product code:
Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.
Recalling firm:
Fort Defiance Industries, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 23, 2021

Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

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.

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▸Full report

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

Recall #:
88624
Lot/product code:
All lots with valid expiration dates
Recalling firm:
Aesthetics Systems Usa Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only

Potential for a wire protrusion through the left heart vent catheter tip

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▸Full report

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

Recall #:
88549
Lot/product code:
Model/Reference Number 12118, Lot Number (GTIN Number): 2018080452 (20643169086702), 2018080452 (00673978462950), 2018090435 (20643169086702), 2018090435 (00673978462950), 2018100525 (20643169086702), 2018100525 (00673978462950), 2018111024 (20643169086702), 2018111024 (00673978462950), 2018111421 (20643169086702), 2018111421 (00673978462950), 2019020369 (20643169086702), 2019020369 (00673978462950), 2019030426 (20643169086702), 2019030426 (00673978462950), 2019031168 (20643169086702), 2019031168 (00673978462950), 2019041190 (20643169086702), 2019041190 (00673978462950), 2019060424 (20643169086702), 2019060424 (00673978462950), 2019070714 (20643169086702), 2019070714 (00673978462950), 2019070715 (20643169086702), 2019070715 (00673978462950), 2019080686 (20643169086702), 2019080686 (00673978462950), 2019081292 (20643169086702), 2019081292 (00673978462950), 2019090394 (20643169086702), 2019090394 (00673978462950), 2019091081 (20643169086702), 2019091081 (00673978462950), 2019100159 (20643169086702), 2019100159 (00673978462950), 2019101446 (20643169086702), 2019101446 (00673978462950), 2019111051 (20643169086702), 2019111051 (00673978462950), 2019120418 (20643169086702), 2019120418 (00673978462950), 2020010051 (20643169086702), 2020010051 (00673978462950), 2020010446 (20643169086702), 2020010446 (00673978462950), 2020020094 (20643169086702), 2020020094 (00673978462950), 2020020764 (20643169086702), 2020020764 (00673978462950), 2020021113 (20643169086702), 2020021113 (00673978462950), 2020040403 (20643169086702), 2020040403 (00673978462950), 2020041125 (20643169086702), 2020041125 (00673978462950), 2020041431 (20643169086702), 2020041431 (00673978462950), 2020050353 (20643169086702), 2020050353 (00673978462950), 2020050919 (20643169086702), 2020050919 (00673978462950), 2020060370 (20643169086702), 2020060370 (00673978462950), 2020060673 (20643169086702), 2020060673 (00673978462950), 2020070374 (20643169086702), 2020070374 (00673978462950), 2020080075 (20643169086702), 2020080075 (00673978462950), 2020120620 (20643169086702), 2020120620 (00673978462950), 2021010035 (20643169086702), 2021010035 (00673978462950), 201906C177 (20643169086702), 201906C177 (00673978462950), 2017090238 (00673978462950), 2018080450 (20643169086702), 2018080451 (20643169086702), 2018090065 (20643169086702), 2018091021 (20643169086702), 2018100523 (20643169086702), 2018100524 (20643169086702), 2018120893 (20643169086702), 2019010457 (20643169086702), 2019010765 (20643169086702), 2019011214 (20643169086702), 2019020007 (20643169086702), 2019030064 (20643169086702), 2019030065 (20643169086702), 2019030721 (20643169086702), 2019031169 (20643169086702), 2019040844 (20643169086702), 2019040845 (20643169086702), 2019040846 (20643169086702), 2019041191 (20643169086702), 2019050167 (20643169086702), 2019050577 (20643169086702), 2019050846 (20643169086702), 2019051127 (20643169086702), 2019060219 (20643169086702), 2019060220 (20643169086702), 2019060687 (20643169086702), 2019060985 (20643169086702), 2019060986 (20643169086702), 2019070613 (20643169086702), 2019071115 (20643169086702), 2019081002 (20643169086702), 2019090072 (20643169086702), 2019090393 (20643169086702), 2019091025 (20643169086702), 2019100418 (20643169086702), 2019101095 (20643169086702), 2019110084 (20643169086702), 2019111050 (20643169086702), 2019120927 (20643169086702), 2020010052 (20643169086702), 2020011621 (20643169086702), 2020020472 (20643169086702), 2020030065 (20643169086702), 2020050354 (20643169086702), 2020050700 (20643169086702), 2020060067 (20643169086702), 2020060068 (20643169086702), 2020060964 (20643169086702), 2020060965 (20643169086702), 2020070055 (20643169086702), 2020070655 (20643169086702), 2020070969 (20643169086702), 2020071273 (20643169086702), 2020081034 (20643169086702), 2020090632 (20643169086702), 2020110762 (20643169086702), 2020120079 (20643169086702), 2020120621 (20643169086702), 2021010553 (20643169086702), 2021011168 (20643169086702), 2021011169 (20643169086702), 2021011170 (20643169086702), 2021031116 (20643169086702), 2021031308 (20643169086702), 2021031309 (20643169086702), 2021040093 (20643169086702), 2021040871 (20643169086702), 2021041149 (20643169086702), 2021050635 (20643169086702), 201901C051 (20643169086702), 201903C128 (20643169086702), 201905C013 (20643169086702), 201906C176 (20643169086702), 202011C198 (20643169086702), 202106C012 (20643169086702), 202106C013 (20643169086702), 202106C014 (20643169086702), 202106C020 (20643169086702), 202106C021 (20643169086702). Expiration date range: 09/30/2020 - 05/19/2024
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

Potential for a wire protrusion through the left heart vent catheter tip

ALL 50 STATES
▸Full report

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

Recall #:
88549
Lot/product code:
Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018100911 (20643169086719), 2018111023 (20643169086719), 2018111419 (20643169086719), 2019120925 (20643169086719), 2018080039 (00673978462943), 2018091020 (00673978462943), 2018100911 (00673978462943), 2018111023 (00673978462943), 2018111419 (00673978462943), 2018120581 (20643169086719), 2018120581 (00673978462943), 2018120582 (20643169086719), 2018120582 (00673978462943), 2018121084 (20643169086719), 2018121084 (00673978462943), 2019010456 (20643169086719), 2019010456 (00673978462943), 2019010764 (20643169086719), 2019010764 (00673978462943), 2019020136 (20643169086719), 2019020136 (00673978462943), 2019020368 (20643169086719), 2019020368 (00673978462943), 2019020758 (20643169086719), 2019020758 (00673978462943), 2019030720 (20643169086719), 2019030720 (00673978462943), 2019031167 (20643169086719), 2019031167 (00673978462943), 2019040262 (20643169086719), 2019040262 (00673978462943), 2019040472 (20643169086719), 2019040472 (00673978462943), 2019040473 (20643169086719), 2019040473 (00673978462943), 2019041189 (20643169086719), 2019041189 (00673978462943), 2019050576 (20643169086719), 2019050576 (00673978462943), 2019060984 (20643169086719), 2019060984 (00673978462943), 2019071114 (20643169086719), 2019071114 (00673978462943), 2019090071 (20643169086719), 2019090071 (00673978462943), 2019091024 (20643169086719), 2019091024 (00673978462943), 2019100417 (20643169086719), 2019100417 (00673978462943), 2019101444 (20643169086719), 2019101444 (00673978462943), 2019111049 (20643169086719), 2019111049 (00673978462943), 2019120925 (00673978462943), 2020010368 (20643169086719), 2020010368 (00673978462943), 2020010445 (20643169086719), 2020010445 (00673978462943), 2020011619 (20643169086719), 2020011619 (00673978462943), 2020011620 (20643169086719), 2020011620 (00673978462943), 2020030064 (20643169086719), 2020030064 (00673978462943), 2020030848 (20643169086719), 2020030848 (00673978462943), 2020030849 (20643169086719), 2020030849 (00673978462943), 2020041429 (20643169086719), 2020041429 (00673978462943), 2020041430 (20643169086719), 2020041430 (00673978462943), 2020050078 (20643169086719), 2020050078 (00673978462943), 2020060672 (20643169086719), 2020060672 (00673978462943), 2020120078 (20643169086719), 2020120078 (00673978462943), 2020120619 (20643169086719), 2020120619 (00673978462943), 2021010032 (20643169086719), 2021010032 (00673978462943), 2021010552 (20643169086719), 2021010552 (00673978462943), 2021011167 (20643169086719), 2021011167 (00673978462943), 2021020486 (20643169086719), 2021020486 (00673978462943), 2021020985 (20643169086719), 2021020985 (00673978462943), 2018080040 (20643169086719), 2018090064 (20643169086719), 2018090434 (20643169086719), 2018091019 (20643169086719), 2018100118 (20643169086719), 2018100522 (20643169086719), 2018101295 (20643169086719), 2018101296 (20643169086719), 2018111418 (20643169086719), 2018111420 (20643169086719), 2018121083 (20643169086719), 201901C047 (20643169086719), 201901C048 (20643169086719), 201901C049 (20643169086719), 2019020759 (20643169086719), 201902C156 (20643169086719), 2019051126 (20643169086719), 201905C012 (20643169086719), 2019060218 (20643169086719), 2019060423 (20643169086719), 2019060686 (20643169086719), 201906C175 (20643169086719), 2019070713 (20643169086719), 2019081001 (20643169086719), 2019081291 (20643169086719), 2019091156 (20643169086719), 2019091157 (20643169086719), 2019100416 (20643169086719), 2019100731 (20643169086719), 2019101094 (20643169086719), 2019101445 (20643169086719), 2019110083 (20643169086719), 2019120089 (20643169086719), 2019120926 (20643169086719), 2020010369 (20643169086719), 2020020093 (20643169086719), 2020020470 (20643169086719), 2020020471 (20643169086719), 2020020763 (20643169086719), 2020030850 (20643169086719), 2020031186 (20643169086719), 2020040402 (20643169086719), 2020040762 (20643169086719), 2020050352 (20643169086719), 2020050699 (20643169086719), 2020050918 (20643169086719), 2020060963 (20643169086719), 2020070653 (20643169086719), 2020070654 (20643169086719), 2020070967 (20643169086719), 2020070968 (20643169086719), 2020071272 (20643169086719), 2020080074 (20643169086719), 2020080408 (20643169086719), 2020080409 (20643169086719), 2020080715 (20643169086719), 2020081032 (20643169086719), 2020081033 (20643169086719), 2020090631 (20643169086719), 2020100785 (20643169086719), 2020101109 (20643169086719), 2020110380 (20643169086719), 202011C197 (20643169086719), 202011C243 (20643169086719), 202011C244 (20643169086719), 2021010033 (20643169086719), 2021010034 (20643169086719), 2021011166 (20643169086719), 2021020487 (20643169086719), 2021020798 (20643169086719), 2021020986 (20643169086719), 2021020987 (20643169086719), 202102C091 (20643169086719), 202102C092 (20643169086719), 202102C093 (20643169086719), 2021030719 (20643169086719), 2021030720 (20643169086719), 2021031307 (20643169086719), 2021040872 (2… (truncated, 5266 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs

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 #:
88640
Lot/product code:
All lots for the following distributed product codes:  Product Code: ECO 85CB - ECO 85CB Lotion Ultrasound 8.5 oz 24/cs    Product Code: ECO 40JBC - ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs    Product Code: ECO 40JMC - ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs    Product Code: NDC P301008 - NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs    Product Code: NDC P301105 - NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs   Product Code: NDC P301115 - NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs    Product Code ECO 30GS - ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl    Product Code: ECO 30GB - ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
Recalling firm:
National Distribution & Contracting Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 24, 2021

ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

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 #:
88640
Lot/product code:
All lots for the following distributed product code:  Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser
Recalling firm:
National Distribution & Contracting Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number: 0020302600

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

ALL 50 STATES
▸Full report

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

Recall #:
88627
Lot/product code:
All currently released lots and future lots
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2021

HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

ALL 50 STATES
▸Full report

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

Recall #:
88627
Lot/product code:
All currently released lots and future lots
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 25, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro) Part Number: 0020302601

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

ALL 50 STATES
▸Full report

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

Recall #:
88627
Lot/product code:
All currently released lots and future lots
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)