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Recalls affecting Montana

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

16,414 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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

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 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 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 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 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

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 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)
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.

ALL 50 STATES
Full report

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, 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

ALL 50 STATES
Full report

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

Recall #:
D-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)
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

ALL 50 STATES
Full report

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

Recall #:
D-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

ALL 50 STATES
Full report

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

Recall #:
D-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, 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

ALL 50 STATES
Full report

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

Recall #:
D-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)
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).

ALL 50 STATES
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).

ALL 50 STATES
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).

ALL 50 STATES
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.

ALL 50 STATES
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

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.

ALL 50 STATES
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)
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

ALL 50 STATES
Full report

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)
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.

ALL 50 STATES
Full report

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.

ALL 50 STATES
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.

ALL 50 STATES
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

ALL 50 STATES
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 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(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)