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Recalls affecting Louisiana

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

16,895 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 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

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UnclassifiedBacteria/virusAnnounced 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.

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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

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UnclassifiedBacteria/virusAnnounced 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

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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.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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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.

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UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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

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UnclassifiedBacteria/virusAnnounced 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

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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Allia Moveo angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

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

Recall #:
98880
Lot/product code:
UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S

Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

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

Recall #:
98571
Lot/product code:
System Serial Numbers:SMS20080542 SMS20120038 SMS20140084 SMS20090038 SMSMA110013 SMS20090239 SMS20080581 SMS20090099 SMS20110202 SMS2010011 SMS20080609 SMS20100127 SMS20090157 SMS20080573 SMS20100230 SMSMA130031 SMS20105020 SMS20080009 SMS20080174 SMS20090316 SMS20090281 SMSMA100027 SMSHP100002 SMSHP100001 SMS20100007 SMSHP100013 SMS20100068 SMS20100010 SMSBL110013 SMSMA120007 SMSNO130066 SMSHP110014 SMSMA130015 SMSPR130007 SMSBL120003 SMSMA110022 SMSNO120020 SMS20130105 SMS20160046 SMSVZ160014 SMS20080264 SMS20170160 SMS20160049 SMS20080358 SMS20080519 SMS20080238 SMS20080135 SMS20080493 SMS20090134 SMS20085122 SMS20070007 SMS20070013 SMS20095174 SMS20080128 SMS20210210 SMS20080283 SMS20080284 SMS20080154 SMS20170211 SMS20080091 SMSHP110015 SMS20090136 SMS20120069 SMS20120023 SMSMA140083 SMS20140060 SMS20080332 SMS20080277 SMS20170376 SMSNO120066 SMS20160121 SMS20090086 SMS20080018 SMS20100098 SMS20100041 SMSBL110001 SMSMA130023 SMSHP130022 SMS20110205 SMS20170164 SMS20180266 SMS20170272 SMS20090054 SMS20060032 SMS20210085 SMS20080133 SMS20080155 SMS20110213 SMS20095208 SMSHP120011 SMS2012008 SMS20120094 SMS20120106 SMS20120107 SMSHP140009 SMSMA150070 SMS20140064 SMS20190264 SMS20100205 SMS20080189 SMS20100205 SMS20080190 SMS20070002 SMS20080162 SMS20100221 SMS20120011 SMS20110186 SMS20140003 SMS20090053 SMS20110139 SMS20095169 SMS20080247 SMS20090154 SMS20090039 SMSHP110007 SMS20200064 SMS20095200 SMS20080061 SMS20090188 SMS20090208 SMSVA090012 SMS20100114 SMS20100126 SMS20090214 SMS20090043 SMSMA110069 SMS20080156 SMS20190259 SMS20080109 SMS20070008 SMS20070001 SMS20210059 SMS20210193 SMS20210278 SMS20210392 SMS20210347 SMS20220070 SMS20220036 SMS20200068 SMS20200330 SMS20220168 SMS20220206 SMS20220299 SMS20220292 SMS20220323 SMS20220360 SMS20230010 SMS20230040 SMS20230071 SMS20230080 SMS20230092 SMS20230180 SMS20230194 SMS20230195 SMS20230217 SMS20230265 SMS20230277 SMS20240004 SMS20240006 SMS20240120 SMS20240206 SMS20200072 SMS20220262 SMS20220264 SMS20230014 SMS20230084 SMS20230121 SMS20230282 SMS20240053 SMS20240205 SMS20240251 SMS20210019 SMS20210171 SMS20210256 SMS20220050 SMS20210360 SMS20220054 SMS20220161 SMS20200100 SMS20200362 SMS20220286 SMS20220378 SMS20230145 SMS20230238 SMS20240055 SMS20240133 SMS20240163 SMS20240201 SMS20240203 SMS20210098 SMS20210170 SMS20220029 SMS20200061 SMS20200201 SMS20210272 SMS20220342 SMS20230019 SMS20230104 SMS20230158 SMS20240097 SMS20240105 SMS20240252 SMS20210400 SMS20230138 SMS20200017 SMS20210013 SMS20220281 SMS20220375 SMS20230275 SMS20220271 SMS20230306 SMS20240221 SMS20200020 SMS20230260 SMS20200099 SMS20220063 SMS20230132 SMS20230130 SMS20230312 SMS20220120 SMS20220159 SMS20200284 SMS20220243 SMS20230237 SMS20230273 SMS20230146 SMS20110211 SMSMA140017 SMS20150007 SMS20150048 SMS20110007 SMS20110108 SMS20080168 SMS20085070 SMS20085070 SMS20100072 SMS20110069 SMS20110070 SMS20080197 SMS20100071 SMS20090176 SMS20090274 SMS20100073 SMS20090275 SMS20080571 SMS20110179 SMSHP130015 SMSMA140028 SMSMA120031 SMSNO160044 SMS20150050 SMSMA130066 SMSMA130067 SMSNO140057 SMSMA130065 SMS20140058 SMSMA150033 SMSMA140048 SMSMA160006 SMSNO160008 SMSMA130053 SMSMA130068 SMSNO140002 SMS20080570 SMSMA130032 SMS20080196 SMS20130034 SMS20080300 SMS20060011 SMS20060012 SMS20080060 SMSMA160065 SMS20200029 SMSNO150091 SMSHP100003 SMS20100094 SMS20110025 SMS20090094 SMS20090095 SMS20090272 SMSHP100004 SMSBL100011 SMSHP100026 SMS20080545 SMS20100055 SMS20090080 SMS20100067 SMS20100160 SMS20100152 SMS20100175 SMS20100215 SMSBL100010 SMSBL110004 SMS20100009 SMSHP090003 SMSBL110005 SMS20090221 SMS20110067 SMS20090220 SMS20090156 SMS20080546 SMSHP090010 SMSBL100004 SMSBL100017 SMSBL100005 SMS20110137 SMSHP100023 SMS20090263 SMS20090181 SMS20100022 SMS20100056 SMSBL100013 SMS20090269 SMS20100179 SMSBL100012 SMS20090270 SMS20100035 SMS20090235 SMS20130106 SMSFD110024 SMSMA130005 SMS20130001 SMS20110170 SMS20120002 SMSHP130001 SMSNO120095 SMSMA130016 SMSMA120020 SMSNO140008 SMSHP120012 SMSFD130001 SMSFD130004 SMSFD130005 SMSMA130029 SMSMA130026 SMSNO120042 SMSBL110036 SMSHP110034 SMS20120113 SMS20120078 SMS20160095 SMSVA110008 SMSMA110018 SMSBL120008 SMS20110183 SMSNO120040 SMSBL110007 SMS20150061 SMSBL110008 SMS20150062 SMSBL110009 SMSBL110028 SMS20110204 SMS20150075 SMS20120115 SMSNO120064 SMSBL110026 SMS20150129 SMSNO120067 SMSBL110022 SMSNO120074 SMSNO110005 SMS20130006 SMSBL110006 SMSNO120068 SMSPR150001 SMSBL110020 SMSNO110009 SMSBL110019 SMS20120001 SMSBL110025 SMSNO150007 SMSMA130002 SMS20150021 SMSNO120092 SMSNO120009 SMS20110126 SMSNO130005 SMSBL110027 SMSNO120004 SMSNO120033 SMSNO150003 SMSNO140032 SMSNO150006 SMSMA150006 SMSNO150011 SMSNO150012 SMSNO150042 SMSMA140029 SMSMA140038 SMSNO140038 SMSHP140010 SMSHP140011 SMS20140074 SMSMA140042 SMS20140067 SMSNO140049 SMSMA140055 SMSMA140054 SMSNO140053 SMS20140015 SMSNO150085 SMS20140104 SMS20150123 SMSMA140080 SMSMA150104 SMSNO150084 SMSHP160003 SMSMA160038 SMSMA160041 SMS20160157 SMS20100201 SMS20110215 SMS20110216 SMSMA110071 … (truncated, 71920 characters total — see the official FDA record for the full value)
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.

Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

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

Recall #:
98998
Lot/product code:
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ Software version Numbers: 2.5.0, 2.5.0.1, 2.5.0.2, and 2.5.1
Recalling firm:
Ventana Medical Systems, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled April 20, 2026

Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs. (packed under 5 labels: Off Grade NFDM Variable; Grade A NFDM LH Basic; Grade A NFDM LH Green Loop rBST Free; Grade A NFDM LH Standard NC rBST Free; NFDM LH Variable Standard)

Potential contamination with Salmonella.

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

Recall #:
H-0698-2026
Lot/product code:
Batch Codes for recalled product all start with A or B full list below. Batch Code and Production Date: B22625-01-1 8/14/2025; B22625-01-2 8/14/2025; B22625-01-3 8/14/2025; B22625-01-4 8/14/2025; B22625-01-5 8/14/2025; B22625-01-6 8/14/2025; B22625-01-7 8/14/2025; B22625-01-8 8/14/2025; B22625-02-1 8/14/2025; B22625-02-2 8/14/2025; B22625-02-3 8/14/2025; B22625-02-4 8/14/2025; B22625-02-5 8/14/2025; B22625-02-6 8/14/2025; B22625-02-7 8/14/2025; B22625-02-8 8/14/2025; B22625-03-1 8/14/2025; B22625-03-2 8/14/2025; B22625-03-3 8/14/2025; B22625-03-4 8/14/2025; B22625-03-5 8/14/2025; B22625-03-6 8/14/2025; B22625-03-7 8/14/2025; B22625-03-8 8/14/2025; B22625-04-1 8/14/2025; B22625-04-2 8/14/2025; B22625-04-3 8/14/2025; B22625-04-4 8/14/2025; B22625-04-5 8/14/2025; B22625-04-6 8/14/2025; B22625-04-7 8/14/2025; B22625-04-8 8/14/2025; B22625-05-1 8/14/2025; B22625-05-2 8/14/2025; B22625-05-3 8/14/2025; B22625-05-4 8/14/2025; B22625-05-5 8/14/2025; B22625-05-6 8/14/2025; B22625-05-7 8/14/2025; B22625-05-8 8/14/2025; B22625-06-1 8/14/2025; B22625-06-2 8/14/2025; B22625-06-3 8/14/2025; B22625-06-4 8/14/2025; B22625-06-5 8/14/2025; B22625-06-6 8/14/2025; B22625-06-7 8/14/2025; B22625-06-8 8/14/2025; B22625-07-1 8/14/2025; B22625-07-2 8/14/2025; B22625-07-3 8/14/2025; B22625-07-4 8/14/2025; B22625-07-5 8/14/2025; B22625-07-6 8/14/2025; B22625-07-7 8/14/2025; B22625-07-8 8/14/2025; B22625-08-1 8/14/2025; B22625-08-2 8/14/2025; B22625-08-3 8/14/2025; B22625-08-4 8/14/2025; B22625-08-5 8/14/2025; B22625-08-6 8/14/2025; B22625-08-7 8/14/2025; B22625-08-8 8/14/2025; B22625-09-1 8/14/2025; B22625-09-2 8/14/2025; B22625-09-3 8/14/2025; B22625-09-4 8/14/2025; B22625-09-5 8/14/2025; B22625-09-6 8/14/2025; B22625-09-7 8/14/2025; B22625-10-1 8/14/2025; B22625-10-2 8/14/2025; B22625-10-3 8/14/2025; B22625-10-4 8/14/2025; B22625-10-5 8/14/2025; B22625-10-6 8/14/2025; B22625-10-7 8/14/2025; B22625-10-8 8/14/2025; B22625-11-1 8/14/2025; B22625-11-2 8/14/2025; B22625-11-3 8/14/2025; B22625-11-4 8/14/2025; B22625-11-5 8/14/2025; B22625-11-6 8/14/2025; B22625-11-7 8/14/2025; B22625-11-8 8/14/2025; B22625-12-1 8/14/2025; B22625-12-2 8/14/2025; B22625-12-3 8/14/2025; B22625-12-4 8/14/2025; B22625-12-5 8/14/2025; B22625-12-6 8/14/2025; B22625-12-7 8/14/2025; B22625-12-8 8/14/2025; B22625-13-1 8/14/2025; B22625-13-2 8/14/2025; B22625-13-3 8/14/2025; B22625-13-4 8/14/2025; B22625-13-5 8/14/2025; B22625-13-6 8/14/2025; B22625-13-7 8/14/2025; B22625-13-8 8/14/2025; B22725-02-1 8/15/2025; B22725-02-2 8/15/2025; B22725-02-3 8/15/2025; B22725-02-4 8/15/2025; B22725-02-5 8/15/2025; B22725-02-6 8/15/2025; B22725-02-7 8/15/2025; B22725-02-8 8/15/2025; B22725-03-1 8/15/2025; B22725-03-2 8/15/2025; B22725-03-3 8/15/2025; B22725-03-4 8/15/2025; B22725-03-5 8/15/2025; B22725-03-6 8/15/2025; B22725-03-7 8/15/2025; B22725-03-8 8/15/2025; B22725-04-1 8/15/2025; B22725-04-2 8/15/2025; B22725-04-3 8/15/2025; B22725-04-4 8/15/2025; B22725-04-5 8/15/2025; B22725-04-6 8/15/2025; B22725-04-7 8/15/2025; B22725-04-8 8/15/2025; B22725-05-1 8/15/2025; B22725-05-2 8/15/2025; B22725-05-3 8/15/2025; B22725-05-4 8/15/2025; B22725-05-5 8/15/2025; B22725-05-6 8/15/2025; B22725-05-7 8/15/2025; B22725-05-8 8/15/2025; B22725-06-1 8/15/2025; B22725-06-2 8/15/2025; B22725-06-3 8/15/2025; B22725-06-4 8/15/2025; B22725-06-5 8/15/2025; B22725-06-6 8/15/2025; B22725-06-7 8/15/2025; B22725-06-8 8/15/2025; B22725-07-1 8/15/2025; B22725-07-2 8/15/2025; B22725-07-6 8/15/2025; B22725-07-7 8/15/2025; B22725-07-8 8/15/2025; B22725-08-1 8/15/2025; B22725-08-2 8/15/2025; B22725-08-3 8/15/2025; B22725-08-4 8/15/2025; B22725-08-5 8/15/2025; B22725-08-6 8/15/2025; B22725-08-7 8/15/2025; B22725-08-8 8/15/2025; B22725-09-1 8/15/2025; B22725-09-2 8/15/2025; B22725-09-3 8/15/2025; B22725-09-4 8/15/2025; B22725-09-5 8/15/2025; B22725-09-6 8/15/2025; B22725-09-7 8/15/2025; B22725-09-8 8/15/2025; B22825-01-1 8/16/2025; B22825-01-2 8/16/2025; B22825-01-3 8/16/2025; B22825-01-4 8/16/2025; B22825-01-5 8/16/2025; B22825-01-6 8/16/2025; B22825-01-7 8/16/2025; B22825-01-8 8/16/2025; B22825-02-1 8/16/2025; B22825-02-2 8/16/2025; B22825-02-3 8/16/2025; B22825-02-4 8/16/2025; B22825-02-5 8/16/2025; B22825-02-6 8/16/2025; B22825-02-7 8/16/2025; B22825-02-8 8/16/2025; B22825-03-1 8/16/2025; B22825-03-2 8/16/2025; B22825-03-3 8/16/2025; B22825-03-4 8/16/2025; B22825-03-5 8/16/2025; B22825-03-6 8/16/2025; B22825-03-7 8/16/2025; B22825-03-8 8/16/2025; B22825-04-1 8/16/2025; B22825-04-2 8/16/2025; B22825-04-3 8/16/2025; B22825-04-4 8/16/2025; B22825-04-5 8/16/2025; B22825-04-6 8/16/2025; B22825-04-7 8/16/2025; B22825-04-8 8/16/2025; B22825-05-1 8/16/2025; B22825-05-2 8/16/2025; B22825-05-3 8/16/2025; B22825-05-4 8/16/2025; B22825-05-5 8/16/2025; B22825-05-6 8/16/2025; B22825-05-7 8/16/2025; B22825-05-8 8/16/2025; B22825-06-1 8/16/2025; B22825-06-2 8/16/2025; B22825-06-3 8/16/2025; B22825-06-4 8/16/2025; B22825-06-5 8/16/2025; B22825-06-6 8/16/2025; B22825-06-7 8/16/2025; B22825-06-8 8/16/2025; B22825-07-1 8/… (truncated, 12153 characters total — see the official FDA record for the full value)
Recalling firm:
California Dairies Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

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

Recall #:
99007
Lot/product code:
Lot Code: UDI (01)00840311346288(0812)8.00 Software Version 8.00 The software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software.
Recalling firm:
Staar Surgical AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Allia IGS 3 Pulse angiographic X-ray system

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

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

Recall #:
98880
Lot/product code:
UDI-DI: 00195278719577; Serial Numbers: M3-24-053, M3-24-124, M3-25-029, M3-25-051, M3-25-053, M3-25-091, M3-25-098, M3-25-124, M3-26-010, M3-26-030
Recalling firm:
GE Medical Systems, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2026

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

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

Recall #:
99007
Lot/product code:
Lot Code: UDI (01)00840311346288(0812)8.00 Software Version 8.00 The software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software.
Recalling firm:
Staar Surgical AG
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Class IIModerate risk
DrugRecalled April 17, 2026

FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

Not guaranteed to be germ-free

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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-0489-2026
Lot/product code:
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Recalling firm:
Harrow Eye LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled April 16, 2026

Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.

It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.

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

Recall #:
98830
Lot/product code:
Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
Recalling firm:
The Binding Site Group, Ltd.
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UnclassifiedRisk not yet known
Medical deviceRecalled April 16, 2026

Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.

It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration.

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

Recall #:
98830
Lot/product code:
Lot Code: Model No; IE800A; EXENT Analyser; UDI; 05051700020886, Serial Number; 101150, Software version; v1.0.20.
Recalling firm:
The Binding Site Group, Ltd.
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Class IIILow risk
DrugRecalled April 16, 2026

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01

Labeling: Missing Label

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0494-2026
Lot/product code:
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Recalling firm:
American Regent, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled April 15, 2026

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.

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

Recall #:
99111
Lot/product code:
Only Model Number provide. Model Number: BENCH R-100
Recalling firm:
Fresh Roast Systems Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled April 15, 2026

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.

Due to customer complaint regarding incorrect display box labeling.

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

Recall #:
98813
Lot/product code:
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
Recalling firm:
Covidien LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled April 15, 2026

Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

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

Recall #:
98871
Lot/product code:
1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
Recalling firm:
Covidien, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782143. UDI: (01)00884838108660(21)42218, (01)00884838108660(21)42225. Serial Numbers: 42218, 42225. 2. Model Number (REF): 782162. UDI: (01)00884838115736(21)71403. Serial Numbers: 71403.
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781178. UDI: None. Serial Numbers: 20088.
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782130. UDI: (01)00884838104402(21)45052, (01)00884838104402(21)42030, (01)00884838104402(21)42151, (01)00884838104402(21)71279, (01)00884838104402(21)71565, (01)00884838104402(21)42104, (01)00884838104402(21)42163, (01)00884838104402(21)42376, (01)00884838104402(21)45179, (01)00884838104402(21)45236, (01)00884838104402(21)45263, (01)00884838104402(21)71532, (01)00884838104402(21)85394, (01)00884838104402(21)85643, (01)00884838104402(21)85644. Serial Numbers: 45052, 42030, 42151, 71279, 71565, 42104, 42163, 42376, 45179, 45236, 45263, 71532, 85394, 85643, 85644.
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

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

Recall #:
98639
Lot/product code:
Lot Code: SW13355 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270005168
Recalling firm:
Dexcom, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782118. UDI: (01)00884838099746(21)85655. Serial Numbers: 85655. 2. Model Number (REF): 782144. UDI: (01)00884838108677(21)71087. Serial Numbers: 71087. 3. Model Number (REF): 782163. UDI: (01)00884838115743(21)42299. Serial Numbers: 42299.
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 782145. UDI: (01)00884838108684(21)17385. Serial Numbers: 17385.
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781270. UDI: (01)00884838095083(21)38109, (01)00884838095083(21)17386, (01)00884838095083(21)38356, (01)00884838095083(21)34211, (01)00884838095083(21)38113, (01)00884838095083(21)17356, (01)00884838095083(21)38111, (01)00884838095083(21)74011, (01)00884838095083(21)24058, (01)00884838095083(21)24066, (01)00884838095083(21)34223. Serial Numbers: 38109, 17386, 38356, 34211, 38113, 17356, 38111, 74011, 24058, 24066, 34223. 2. Model Number (REF): 782113. UDI: (01)00884838098909(21)38066, (01)00884838098909(21)38117, (01)00884838098909(21)17384. Serial Numbers: 38066, 38117, 17384.
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781260. UDI: (01)00884838095076(21)21554, (01)00884838095076(21)13018, (01)00884838095076(21)12033. Serial Numbers: 21554, 13018, 12033. 2. Model Number (REF): 782112. UDI: (01)00884838098886(21)30143, (01)00884838098886(21)22051, (01)00884838098886(21)32156. Serial Numbers: 30143, 22051, 32156.
Recalling firm:
Philips North America
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Class IIILow risk
DrugRecalled April 14, 2026

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0490-2026
Lot/product code:
Lot #: 640911253, Exp Date. 09/14/2027.
Recalling firm:
Premier Dental Products Co
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781358. UDI: (01)00884838088115(21)45121, (01)00884838088115(21)45148, (01)00884838088115(21)45160, (01)00884838088115(21)45438, (01)00884838088115(21)45034, (01)00884838088115(21)45049, (01)00884838088115(21)45066, (01)00884838088115(21)45090, (01)00884838088115(21)45141, (01)00884838088115(21)45149, (01)00884838088115(21)45170, (01)00884838088115(21)45250, (01)00884838088115(21)45290, (01)00884838088115(21)45085, (01)00884838088115(21)45312, (01)00884838088115(21)45376, (01)00884838088115(21)45122, (01)00884838088115(21)45169, (01)00884838088115(21)45191, (01)00884838088115(21)45192, (01)00884838088115(21)45203, (01)00884838088115(21)45204, (01)00884838088115(21)45207, (01)00884838088115(21)45220, (01)00884838088115(21)45228, (01)00884838088115(21)45229, (01)00884838088115(21)45249, (01)00884838088115(21)45278, (01)00884838088115(21)45279, (01)00884838088115(21)45320, (01)00884838088115(21)45028, (01)00884838088115(21)45195, (01)00884838088115(21)45174, (01)00884838088115(21)45165, (01)00884838088115(21)45382, (01)00884838088115(21)45011, (01)00884838088115(21)45055, (01)00884838088115(21)45075, (01)00884838088115(21)45113, (01)00884838088115(21)45147, (01)00884838088115(21)45152, (01)00884838088115(21)45235, (01)00884838088115(21)45237, (01)00884838088115(21)45245, (01)00884838088115(21)45264, (01)00884838088115(21)45269, (01)00884838088115(21)45277, (01)00884838088115(21)45316, (01)00884838088115(21)45322, (01)00884838088115(21)45337, (01)00884838088115(21)45338, (01)00884838088115(21)45353, (01)00884838088115(21)45398, (01)00884838088115(21)45414, (01)00884838088115(21)45429, (01)00884838088115(21)45051. Serial Numbers: 45121, 45148, 45160, 45438, 45034, 45049, 45066, 45090, 45141, 45149, 45170, 45250, 45290, 45085, 45312, 45376, 45122, 45169, 45191, 45192, 45203, 45204, 45207, 45220, 45228, 45229, 45249, 45278, 45279, 45320, 45028, 45195, 45174, 45165, 45382, 45011, 45055, 45075, 45113, 45147, 45152, 45235, 45237, 45245, 45264, 45269, 45277, 45316, 45322, 45337, 45338, 45353, 45398, 45414, 45429, 45051. 2. Model Number (REF): 782107. UDI: (01)00884838098336(21)45590, (01)00884838098336(21)62158, (01)00884838098336(21)62180, (01)00884838098336(21)62044, (01)00884838098336(21)45567, (01)00884838098336(21)62031, (01)00884838098336(21)62166, (01)00884838098336(21)62184, (01)00884838098336(21)62190, (01)00884838098336(21)62240, (01)00884838098336(21)45519, (01)00884838098336(21)45533, (01)00884838098336(21)62024, (01)00884838098336(21)62047, (01)00884838098336(21)62048, (01)00884838098336(21)62051, (01)00884838098336(21)62052, (01)00884838098336(21)45554, (01)00884838098336(21)62145, (01)00884838098336(21)62146, (01)00884838098336(21)62148, (01)00884838098336(21)45500, (01)00884838098336(21)45501, (01)00884838098336(21)45510, (01)00884838098336(21)45511, (01)00884838098336(21)45514, (01)00884838098336(21)45516, (01)00884838098336(21)45518, (01)00884838098336(21)45589, (01)00884838098336(21)62017, (01)00884838098336(21)62039, (01)00884838098336(21)62073, (01)00884838098336(21)62081, (01)00884838098336(21)62088, (01)00884838098336(21)45521, (01)00884838098336(21)45600, (01)00884838098336(21)45563, (01)00884838098336(21)45570, (01)00884838098336(21)62153, (01)00884838098336(21)62181, (01)00884838098336(21)62182, (01)00884838098336(21)62183. Serial Numbers: 45590, 62158, 62180, 62044, 45567, 62031, 62166, 62184, 62190, 62240, 45519, 45533, 62024, 62047, 62048, 62051, 62052, 45554, 62145, 62146, 62148, 45500, 45501, 45510, 45511, 45514, 45516, 45518, 45589, 62017, 62039, 62073, 62081, 62088, 45521, 45600, 45563, 45570, 62153, 62181, 62182, 62183. 3. Model Number (REF): 782136. UDI: (01)00884838108608(21)28568, (01)00884838108608(21)28503, (01)00884838108608(21)28515, (01)00884838108608(21)28528, (01)00884838108608(21)28577. Serial Numbers: 28568, 28503, 28515, 28528, 28577.
Recalling firm:
Philips North America
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UnclassifiedRisk not yet known
Medical deviceRecalled April 14, 2026

Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

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

Recall #:
98779
Lot/product code:
1. Model Number (REF): 781359. UDI: (01)00884838090057(21)48218, (01)00884838090057(21)48233. Serial Numbers: 48218, 48233. 2. Model Number (REF): 782108. UDI: (01)00884838098343(21)48652, (01)00884838098343(21)48551, (01)00884838098343(21)48669. Serial Numbers: 48652, 48551, 48669. 3. Model Number (REF): 782139. UDI: (01)00884838108639(21)29076, (01)00884838108639(21)29079. Serial Numbers: 29076, 29079.
Recalling firm:
Philips North America
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