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Recalls affecting Vermont

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

16,288 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 5, 2021

Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A899916, Lot NGFR0101, UDI (01)00801741074011(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A800365, Lots: NGFR3131, UDI (01)00801741073960(17)201220(10); NGFR3295, UDI (01)00801741073960(17)201220(10); NGFR4413, UDI (01)00801741073960(17)201220(10); NGFR4599, UDI (01)00801741073960(17)201220(10); and NGFS3150 UDI (01)00801741073960(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A399400A, Lot NGFR3569, UDI (01)00801741073915(17)201228(10); Lot NGFR2691, UDI (01)00801741073915(17)201228(10)   Expanded 10/8/2021 adding Lot NGFR2691, UDI (01)00801741073915(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A300316A, Lots: NGEVX104 (exp. 08/31/2022), UDI (01)00801741073731(17)201228(10); NGFR3628 (02/28/2023), UDI (01)00801741073731(17)201228(10); GFS1114 (02/28/2023), UDI (01)00801741073731(17)201228(10); and NGFS1166 (02/28/2023), UDI (01)00801741073731(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A942216, Lot NGFS3274, UDI (01)00801741074110(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10)  and NGFS1312, UDI (01)00801741073687(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10);  NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A303316A, Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10); NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10); NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10); and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 5, 2021

Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device

There is potential for packaging defects that may impact the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
88499
Lot/product code:
Catalog A300318A, Lot NGEVX106, UDI (01)00801741073748(17)201228(10)
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

ALL 50 STATES
Full report

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

Recall #:
88514
Lot/product code:
Afiniti Diagnostic Ultrasound Systems: Affiniti 30 Model Number: 795121 Serial Numbers/UDI Codes US219E1452 (01)00884838074187(21)US219E1452 US220E0262 (01)00884838074187(21)US220E0262 US320E1098 (01)00884838074187(21)US320E1098 US320E1099 (01)00884838074187(21)US320E1099 US918E0145 (01)00884838074187(21)US918E0145 USN18E0607 (01)00884838074187(21)USN18E0607 USN18E1617 (01)00884838074187(21)USN18E1617 USN19E2219 (01)00884838074187(21)USN19E2219 USN19E2220 (01)00884838074187(21)USN19E2220 USN19E2221 (01)00884838074187(21)USN19E2221 Affiniti 30 Model Number: 795218 Serial Numbers/UDI Codes PU220E1330 N/A PU220E1331 N/A PU220E1332 N/A PU220E1333 N/A PU220E1334 N/A PU220E1335 N/A PU420E0442 N/A PU420E0658 N/A PU420E0659 N/A PU420E0660 (01)00884838097957 PU420E0761 (01)00884838074187 PU520E0703 (01)00884838074187 PU520E0713 N/A PU520E0854 (01)00884838074187 PU520E0855 N/A PU520E0856 N/A PU520E0857 N/A PU520E0858 N/A PU520E0859 N/A PU520E0861 N/A PU520E0965 N/A PU520E0966 N/A PU520E0967 N/A PU520E0968 N/A PU520E1012 N/A PU520E1013 (01)00884838074187 PU520E1014 (01)00884838074187 PU520E1015 N/A PU520E1016 N/A PU520E1017 (01)00884838074187 PU520E2820 (01)00884838097957 PU520E2821 (01)00884838097957 PU520E2831 (01)00884838097957 PU620E0090 (01)00884838097957 PU720E0464 (01)00884838074187 PU720E0468 N/A PU720E0611 (01)00884838097957 PU720E0800 (01)00884838097957 PU720E0801 (01)00884838097957 PU720E0803 N/A PU720E0804 N/A PU820E0248 N/A PU820E0249 N/A PU820E0347 (01)00884838097957 PU820E0349 N/A PU820E0525 N/A PU820E0526 N/A PU820E0535 N/A PU820E0536 N/A PU820E0540 N/A PU820E0541 N/A PU820E0544 (01)00884838074187 PU820E0545 N/A PU820E0654 (01)00884838074187 PUD19E0772 N/A PUD19E0832 N/A PUD19E0833 N/A US117E1004 (01)00884838074187(21)US117E1004 US118E1385 (01)00884838074187(21)US118E1385 US119E0798 (01)00884838074187(21)US119E0798 US119E0912 (01)00884838074187(21)US119E0912 US119E1661 (01)00884838074187(21)US119E1661 US119E1662 (01)00884838074187(21)US119E1662 US120E0309 (01)00884838074187(21)US120E0309 US120E0310 (01)00884838074187(21)US120E0310 US120E0340 (01)00884838074187(21)US120E0340 US120E0341 (01)00884838074187(21)US120E0341 US120E0342 (01)00884838074187(21)US120E0342 US120E0448 (01)00884838074187(21)US120E0448 US120E0449 (01)00884838074187(21)US120E0449 US120E0507 (01)00884838074187(21)US120E0507 US120E0630 (01)00884838074187(21)US120E0630 US120E0651 (01)00884838074187(21)US120E0651 US120E0652 (01)00884838074187(21)US120E0652 US120E0653 (01)00884838074187(21)US120E0653 US120E0654 (01)00884838074187(21)US120E0654 US120E0655 (01)00884838074187(21)US120E0655 US120E0656 (01)00884838074187(21)US120E0656 US120E0657 (01)00884838074187(21)US120E0657 US120E0719 (01)00884838074187(21)US120E0719 US120E0720 (01)00884838074187(21)US120E0720 US120E0721 (01)00884838074187(21)US120E0721 US120E0722 (01)00884838074187(21)US120E0722 US120E0723 (01)00884838074187(21)US120E0723 US120E0724 (01)00884838074187(21)US120E0724 US120E0778 (01)00884838074187(21)US120E0778 US120E0811 (01)00884838074187(21)US120E0811 US120E0812 (01)00884838074187(21)US120E0812 US120E0813 (01)00884838074187(21)US120E0813 US120E0814 (01)00884838074187(21)US120E0814 US120E0815 (01)00884838074187(21)US120E0815 US120E0816 (01)00884838074187(21)US120E0816 US120E0817 (01)00884838074187(21)US120E0817 US120E0818 (01)00884838074187(21)US120E0818 US120E0819 (01)00884838074187(21)US120E0819 US120E0820 (01)00884838074187(21)US120E0820 US120E0842 (01)00884838074187(21)US120E0842 US120E0843 (01)00884838074187(21)US120E0843 US120E0892 (01)00884838074187(21)US120E0892 US120E1001 (01)00884838074187(21)US120E1001 US120E1002 (01)00884838074187(21)US120E1002 US120E1003 (01)00884838074187(21)US120E1003 US120E1044 (01)00884838074187(21)US120E1044 US120E1045 (01)00884838074187(21)US120E1045 US120E1046 (01)00884838074187(21)US120E1046 US120E1047 (01)00884838074187(21)US120E1047 US120E1048 (01)00884838074187(21)US120E1048 US120E1049 (01)00884838074187(21)US120E1049 US120E1050 (01)00884838074187(21)US120E1050 US120E1051 (01)00884838074187(21)US120E1051 US120E1052 (01)00884838074187(21)US120E1052 US120E1053 (01)00884838074187(21)US120E1053 US120E1054 (01)00884838074187(21)US120E1054 US120E1150 (01)00884838074187(21)US120E1150 US120E1151 (01)00884838074187(21)US120E1151 US120E1152 (01)00884838074187(21)US120E1152 US120E1153 (01)00884838074187(21)US120E1153 US120E1189 (01)00884838074187(21)US120E1189 US120E1190 (01)00884838074187(21)US120E1190 US120E1218 (01)00884838074187(21)US120E1218 US120E1298 (01)00884838074187(21)US120E1298 US120E1402 (01)00884838074187(21)US120E1402 US120E1403 (01)00884838074187(21)US120E1403 US120E1404 (01)00884838074187(21)US120E1404 US120E1405 (01)00884838074187(21)US120E1405 US120E1466 (01)00884838074187(21)US120E1466 US120E1467 (01)00884838074187(21)US120E1467 US120E1535 (01)00884838074187(21)US120E1535 US120E1539 (01)00884838074187(21)US120E1539 US120E1575 (01)00884838074187(21)US120E1575 US120E1576 (01)00884838074187(21)US120E1576 US120E1610 (01)00884… (truncated, 163251 characters total — see the official FDA record for the full value)
Recalling firm:
Philips Ultrasound Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

Medtronic HVAD Pump Implant Kits

There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.

ALL 50 STATES
Full report

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

Recall #:
88541
Lot/product code:
Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

ALL 50 STATES
Full report

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

Recall #:
88455
Lot/product code:
Model H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230  Model H-1129: Product Code H-1129
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

ALL 50 STATES
Full report

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

Recall #:
88455
Lot/product code:
Model IR-40: Product Code IR-40   Model IR-500: Product Code IR-500   Model IR-600: Product Code IR-600   Model IRI-600: Product Code IRI-600   Model IRI-600B: Product Code IRI-600B   Model IR-700: Product Code IR-700
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 6, 2021

EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

ALL 50 STATES
Full report

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

Recall #:
88514
Lot/product code:
EPIQ Diagnostic Ultrasound Systems: EPIQ 5 Model Number: 795120 Serial Numbers/UDI Codes US118C0391/ (01)00884838047686(21)US118C0391; US118C1388/ (01)00884838047686(21)US118C1388; US118C1389/ (01)00884838047686(21)US118C1389; US119C0516/ (01)00884838047686(21)US119C0516; US119C0517/ (01)00884838047686(21)US119C0517; US119C0644/ (01)00884838047686(21)US119C0644; US121C0839/ (01)00884838047686(21)US121C0839; US219C0823/ (01)00884838047686(21)US219C0823; US219C0949/ (01)00884838047686(21)US219C0949; US319C0210/ (01)00884838047686(21)US319C0210; US518C1519/ (01)00884838047686(21)US518C1519; US518C1528/ (01)00884838047686(21)US518C1528; US719C0285/ (01)00884838047686(21)US719C0285; US719C0603/ (01)00884838047686(21)US719C0603; US918C0543/ (01)00884838047686(21)US918C0543; US918C1811/ (01)00884838047686(21)US918C1811; USD18C1243/ (01)00884838047686(21)USD18C1243; EPIQ 5C Model Number: 795205 Serial Numbers/UDI Codes US114C0239/ N/A; US114C0240/ N/A; US114C0241/ N/A; US114C0271/ N/A; US114C0272/ N/A; US114C0286/ N/A; US114C0287/ N/A; US114C0308/ N/A; US114C0366/ N/A; US117C0337/ (01)00884838047686(21)US117C0337; US215C0536/ N/A; US315C0582/ N/A; US316C0339/ N/A; US414C0158/ N/A; US514C0541/ N/A; US614C0745/ N/A; US614C0854/ N/A; US615C1170/ N/A; US615C1171/ N/A; US615C1172/ N/A; US617C0803/ (01)00884838047686(21)US617C0803; US617C0882/ (01)00884838047686(21)US617C0882; US715C0376/ N/A; US716C0748/ N/A; US717C0579/ (01)00884838047686(21)US717C0579; US815C1244/ N/A; US816C1004/ (01)00884838047686(21)US816C1004; US816C1005/ (01)00884838047686(21)US816C1005; US816C1031/ (01)00884838047686(21)US816C1031; US816C1089/ (01)00884838047686(21)US816C1089; US818C1155/ (01)00884838047686(21)US818C1155; US818C1156/ (01)00884838047686(21)US818C1156; US914C0244/ N/A; US914C0246/ N/A; US914C0998/ N/A; USD13C0525/ N/A; USD13C0526/ N/A; USD13C0527/ N/A; USD13C0615/ N/A; USD13C0616/ N/A; USD13C0617/ N/A; USD13C0618/ N/A; USD13C0619/ N/A; USD13C0620/ N/A; USD13C0621/ N/A; USD13C0670/ N/A; USD13C0671/ N/A; USD13C0709/ N/A; USD14C0168/ N/A; USD14C0370/ N/A; USD14C0371/ N/A; USD18C0387/ (01)00884838047686(21)USD18C0387; USO13C0369/ N/A; USO13C0398/ N/A; USO13C0532/ N/A; USO13C0536/ N/A; USO16C0440/ (01)00884838047686(21)USO16C0440; USO17C1366/ (01)00884838047686(21)USO17C1366; USO17C1367/ (01)00884838047686(21)USO17C1367; USO17C1368/ (01)00884838047686(21)USO17C1368; EPIQ 5G Model Number: 795204 Serial Numbers/UDI Codes US114C0321 N/A US114C0534 N/A US116C0562 N/A US116C0725 N/A US117C0310 (01)00884838047686(21)US117C0310 US117C0816 (01)00884838047686(21)US117C0816 US117C0819 (01)00884838047686(21)US117C0819 US117C0864 (01)00884838047686(21)US117C0864 US117C1215 (01)00884838047686(21)US117C1215 US118C0677 (01)00884838047686(21)US118C0677 US118C0678 (01)00884838047686(21)US118C0678 US118C0679 (01)00884838047686(21)US118C0679 US118C0680 (01)00884838047686(21)US118C0680 US118C0682 (01)00884838047686(21)US118C0682 US119C0380 (01)00884838047686(21)US119C0380 US119C0686 (01)00884838047686(21)US119C0686 US119C0687 (01)00884838047686(21)US119C0687 US119C0688 (01)00884838047686(21)US119C0688 US120B0893 (01)00884838088658(21)US120B0893 US120B0919 (01)00884838088658(21)US120B0919 US120B0922 (01)00884838088658(21)US120B0922 US120B0923 (01)00884838088658(21)US120B0923 US120B0927 (01)00884838088658(21)US120B0927 US120B0928 (01)00884838088658(21)US120B0928 US120B0929 (01)00884838088658(21)US120B0929 US120B0930 (01)00884838088658(21)US120B0930 US120B0931 (01)00884838088658(21)US120B0931 US120B0932 (01)00884838088658(21)US120B0932 US120B0933 (01)00884838088658(21)US120B0933 US120B0938 (01)00884838047693(21)US120B0938 US120C0083 (01)00884838047686(21)US120C0083 US120C0115 (01)00884838047686(21)US120C0115 US120C0116 (01)00884838047686(21)US120C0116 US120C0117 (01)00884838047686(21)US120C0117 US120C0193 (01)00884838047686(21)US120C0193 US120C0196 (01)00884838047686(21)US120C0196 US120C0274 (01)00884838047686(21)US120C0274 US120C0278 (01)00884838047686(21)US120C0278 US120C0279 (01)00884838047686(21)US120C0279 US120C0281 (01)00884838047686(21)US120C0281 US120C0282 (01)00884838047686(21)US120C0282 US120C0283 (01)00884838047686(21)US120C0283 US120C0353 (01)00884838047686(21)US120C0353 US120C0354 (01)00884838047686(21)US120C0354 US120C0355 (01)00884838047686(21)US120C0355 US120C0407 (01)00884838047686(21)US120C0407 US120C0408 (01)00884838047686(21)US120C0408 US120C0409 (01)00884838047686(21)US120C0409 US120C0410 (01)00884838047686(21)US120C0410 US120C0411 (01)00884838047686(21)US120C0411 US120C0464 (01)00884838047686(21)US120C0464 US120C0465 (01)00884838047686(21)US120C0465 US120C0498 (01)00884838047686(21)US120C0498 US120C0499 (01)00884838047686(21)US120C0499 US120C0501 (01)00884838047686(21)US120C0501 US120C0502 (01)00884838047686(21)US120C0502 US120C0503 (01)00884838047686(21)US120C0503 US120C0504 (01)00884838047686(21)US120C0504 US120C0505 (01)00884838047686(21)US120C0505 US120C0582 (01)00884838047686(21)US120C0582 US120C0583 (01)00884838047686(21)US120C… (truncated, 252668 characters total — see the official FDA record for the full value)
Recalling firm:
Philips Ultrasound Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2021

DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)

There is a potential for open seals which can compromise sterility.

ALL 50 STATES
Full report

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

Recall #:
88460
Lot/product code:
ICC 187660 - Lots 9B02984Y, 9G04308, 9K05775, 9L00556, 0A03460, and 9A04124Y ICC 187957 - Lots 9J02859, 9H02226, 9H04865, 9L02456 ICC 187955 - Lots 9L01731, 9L04890, 9K02656, 9H01234, 9M01779, and 9H00183
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 11, 2021

Stretch Leveller Model Number: 3156200 - 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.

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Full report

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

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

Ingenia 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: 781341 781396

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: 781341 Serial Number Unique Device Identifier (UDI#) 70085 N/A 70160 N/A 70246 N/A 70349 N/A 70348 N/A 70407 N/A 70723 N/A 70873 N/A 70917 N/A 87101 (01)00884838055322(21)87101 70040 N/A 70229 N/A 70607 N/A 70763 N/A 84126 (01)00884838055322(21)84126 84030 (01)00884838055322(21)84030 84108 (01)00884838055322(21)84108 84234 (01)00884838055322(21)84234 84257 N/A 84596 (01)00884838055322(21)84596 87005 (01)00884838055322(21)87005 87146 (01)00884838055322(21)87146 70279 N/A 70367 N/A 70374 N/A 70375 N/A 70461 N/A 70471 N/A 70742 N/A 70764 N/A 70064 N/A 70113 N/A 70604 N/A 70603 N/A 70605 N/A 70725 N/A 70704 N/A 70768 N/A 70794 N/A 70766 N/A 70812 N/A 70767 N/A 84539 (01)00884838055322(21)84539 70780 N/A 84566 (01)00884838055322(21)84566 84621 (01)00884838055322(21)84621 84667 (01)00884838055322(21)84667 84629 (01)00884838055322(21)84629 84962 (01)00884838055322(21)84962 87214 (01)00884838055322(21)87214 87215 (01)00884838055322(21)87215 70071 N/A 70284 N/A 70311 N/A 70916 N/A 84098 (01)00884838055322(21)84098 84343 (01)00884838055322(21)84343 84249 (01)00884838055322(21)84249 84891 (01)00884838055322(21)84891 84765 (01)00884838055322(21)84765 70110 N/A 70111 N/A 70177 N/A 70161 N/A 70204 N/A 70205 N/A 70244 N/A 70269 N/A 70088 N/A 70446 N/A 70448 N/A 70470 N/A 70665 N/A 70678 N/A 70459 N/A 70755 N/A 70666 N/A 70664 N/A 70663 N/A 70667 N/A 70668 N/A 70662 N/A 70864 N/A 70845 N/A 70943 N/A 70942 N/A 70866 N/A 70868 N/A 70867 N/A 70969 N/A 70691 N/A 70612 (01)00884838055322(21)70612 84178 (01)00884838055322(21)84178 84179 (01)00884838055322(21)84179 84180 (01)00884838055322(21)84180 84300 (01)00884838055322(21)84300 84302 (01)00884838055322(21)84302 84381 (01)00884838055322(21)84381 84330 (01)00884838055322(21)84330 84303 (01)00884838055322(21)84303 84385 (01)00884838055322(21)84622 84384 (01)00884838055322(21)84384 84387 (01)00884838055322(21)84387 84451 (01)00884838055322(21)84451 84976 (01)00884838055322(21)84976 87028 (01)00884838055322(21)87028 84844 (01)00884838055322(21)84844 87271 (01)00884838055322(21)87271 84622 (01)00884838055322(21)84385 87040 (01)00884838055322(21)87040 87061 (01)00884838055322(21)87061 87098 (01)00884838055322(21)87098 87124 (01)00884838055322(21)87124 87125 (01)00884838055322(21)87125 87126 (01)00884838055322(21)87126 87180 (01)00884838055322(21)87180 87206 (01)00884838055322(21)87206 87207 (01)00884838055322(21)87207 87221 (01)00884838055322(21)87221 87222 (01)00884838055322(21)87222 70488 N/A 70832 N/A 70286 N/A 70221 N/A 70655 N/A 70641 N/A 70730 N/A 70712 N/A 70858 N/A 70851 N/A 84644 (01)00884838055322(21)84644 84649 (01)00884838055322(21)84649 70067 N/A 70074 N/A 70101 N/A 70114 N/A 70104 N/A 70073 N/A 70009 N/A 70278 N/A 70206 N/A 70306 N/A 70452 N/A 70623 N/A 70622 N/A 70590 N/A 70589 N/A 70588 N/A 70696 N/A 70705 N/A 70754 N/A 84042 N/A 70869 N/A 70975 (01)00884838055322(21)70975 84084 (01)00884838055322(21)84084 84203 (01)00884838055322(21)84203 84315 (01)00884838055322(21)84315 84555 (01)00884838055322(21)84555 84268 (01)00884838055322(21)84268 84788 N/A 87027 (01)00884838055322(21)87027 70424 N/A 84092 (01)00884838055322(21)84092 84311 (01)00884838055322(21)84311 84766 (01)00884838055322(21)84766 84744 (01)00884838055322(21)84744 84890 (01)00884838055322(21)84890 84730 (01)00884838055322(21)84730 84986 (01)00884838055322(21)84986 84982 (01)00884838055322(21)84982 87151 (01)00884838055322(21)87151 87171 (01)00884838055322(21)87171 87191 (01)00884838055322(21)87191 84010 N/A 70981 N/A 84082 N/A 84110 (01)00884838055322(21)84110 70997 (01)00884838055322(21)70997 84066 (01)00884838055322(21)84066 84197 (01)00884838055322(21)84197 70974 (01)00884838055322(21)70974 84150 (01)00884838055322(21)84150 84204 (01)00884838055322(21)84204 84242 (01)00884838055322(21)84242 70987 (01)00884838055322(21)70987 84230 (01)00884838055322(21)84230 84262 (01)00884838055322(21)84262 84291 (01)00884838055322(21)84291 84256 N/A 84290 (01)00884838055322(21)84290 84310 (01)00884838055322(21)84310 84287 (01)00884838055322(21)84287 84321 (01)00884838055322(21)84321 84318 (01)00884838055322(21)84318 84320 (01)00884838055322(21)84320 84383 (01)00884838055322(21)84383 84327 (01)00884838055322(21)84327 84397 (01)00884838055322(21)84397 84503 (01)00884838055322(21)84503 84411 (01)00884838055322(21)84411 84452 (01)00884838055322(21)84452 84328 (01)00884838055322(21)84328 84417 (01)00884838055322(21)84417 84307 (01)00884838055322(21)84307 84414 (01)00884838055322(21)84414 84515 (01)00884838055322(21)84515 84496 (01)00884838055322(21)84496 84582 (01)00884838055322(21)84582 84497 (01)00884838055322(21)84497 84585 (01)00884838055322(21)84585 84695 (01)00884838055322(21)84695 84427 (01)00884838055322(21)84427 84422 (01)00884838055322(21)84422 84591 (01)00884838055322(21)84591 84399 (01)00884838055322(21)84399 84756 (01)00884838055322(21)84756 84597 N/A 84645 (01)00884838055322(21)84645 84787 (01)00884838055322(21)84787 84686 (01)00884838055322(21)84686 84736 (01)00884838055322(21)84736 84531 (01)00884838… (truncated, 39213 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 11, 2021

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

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

ALL 50 STATES
Full report

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

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

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

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

ALL 50 STATES
Full report

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

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

Ingenia 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 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)