BIGNOPE
Ko-fi

Recalls affecting Wisconsin

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

16,962 recalls found
NewOld
High RiskLow Risk
AllClear

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

▸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 Alive — Moringa 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. Braun — 0.9% 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 Value — Organic 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 Temptations — Chocolatey 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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸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 Sprouts — Robust 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

Martina — Mangoes

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 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 A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing 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 A303416A, Lot NGFS1844, UDI (01)00801741073823(17)201228(10); NGFS1845, UDI (01)00801741073823(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 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 A943216, 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 A943216, Lot NGEVX108, UDI (01)00801741100833(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 A300314A, 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 A300314A, Lot NGFR3627, UDI (01)00801741073724(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 A897514, SureStep" Foley Tray, Silicone, 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 A897514, Lot NGFR2808, UDI (01)00801741104510(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 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 A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing 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 A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10);  NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10)  Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(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 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 A800061, 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 A800061, Lot NGFR3658, UDI (01)00801741104848(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 A902416, SureStep" Foley Tray, Silicone, 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 A902416, Lot NGFR4567, UDI (01)00801741074042(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 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 6, 2021

Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

AKAZCACODEFLGAIAINLAMAMDMIMNMOMSMTNCNDNJNMNVNYOHOKORPASDTXUTWAWIWVWY
▸Full report

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

Recall #:
88526
Lot/product code:
1. Model Number: 2090255-001 (Centricity Universal Viewer with PACS-IW foundation software versions 6.0 through 6.0 SP7.1) System ID (UDI-DI if applicable): PMIO14194768, PMIO20084199, PACS-IW-231, CITRUSVAL20884363, CITRUSVAL20884364, CITRUSVAL20884365, PACS-IW-155, PRIMEHEAL02315681, PRIMEHEAL20501355, PARKVIEWC21200827 (840682103800), PARKVIEWC21200830 (840682103800), PACS-IWUVN2-441, QUEEN19630914, QUEEN19630915, QUEEN19630916T, QUEEN20553950, 203268UVSW, DELAWAREC01589220, PACS-IW-462UV, PACS-IW-462UVN1, PACS-IW-126, PACS-IW-1062, OFMC01819402, OFMC20791988, HGS01766912, HGS20584004 (840682103800), GA001PACTRL01, TRGI02180958, DRY01810490, DRY19670358, PACS-IW-101, RML20502096, PACS-IWUV-239, PACS-IW-00813, PHS01374810, 01722652SEAS, 02031921SEASN1, MARYLANDF17985489, MYRTLEHIL17713895, MYRTLEHIL01444483, MYRTLEHIL17713895, VT01766830, VT01977629, PACS-IW-2637, SRMC01982629, PACS-IWUV-568, 1-142022244, PACS-IWUV-1131, OGAA02373799NOD1, ALLG00558571 (840682103800), EXC02189547, EXC01584099, PACS-IW-574, PRIME HEAL19508102, PRIME HEAL19050922, PRIME HEAL19050921, PACS-IW-219, ANCL00558570, ANCL02157634, NSW01452088, NSW20080545, MARYLANDF17985489, PACS-IW-518UV (840682103800), MTGD02393053, MTGD00558454, PACS-IW-44, QUENTIN01970717, LAKESIDEM02256808, BMC12P00558644P1, BMC12T02267839, BMC12N01271417N1, PACS-IW-58, SMCO02039946PC (840682103800), BWH01301357, PACS-IW-349, PACS-IW-255, 1-357059471, CAROCOMMU02205222, CAROCOMMU01459013, CSPA01291589 (840682103800), CSPA02097167 (840682103800), PACS-IW-79, PACS-IW-93, 1-276423210, MFCI01448329, LSFH02032334, CORONAREG01300927, 951737IWUWWN1, CORONAREG02288447, 1-382753509, CITRUSVAL19618406, MGMC02288391, MGMC02398531, 1-473998727, BARRETTHO00558704, BARRETTHO17737529, FORTDUNCA01298556 (840682103800), FORTDUNCA02395799 (840682103800), 1-283597082, TTU01973509, AVHL02396030, PACS-IW-511, PACSIWTEST, PACS-IW-386UV (840682103800), PACS-IW-486-UV (840682103800), PACS-IW-486-UVN1 (840682103800), PACS-IW-390 (840682103800), PACS-IW-202TEST, PACS-IW-202, HZC14961014, AVHL02396026, AVHL02396027, AVHL02396028, AVHL02396029, PACS-IW-419, PMRM14768587UVProxy, HANNIBALR02179353 (840682103800), TESTHANNIBALR02255613 (840682103800), HANN16174584UVProxy (840682103800), PACS-IW-189 (840682103800), HARTSDALE14768195 (840682103800), HOA01451973 (840682103800), RML01448365 (840682103800), ICA01367198 (840682103800), ICA14776604 (840682103800), JKS01452133 (840682103800), JKS14776447UVSFNode (840682103800), JKS14776448UVProxy (840682103800), JKS14776449UVTest (840682103800), PACS-IW-181, GTEC01477448, GTEC01477447, GTEC15993728UVProxy3, 1-592001096 (840682103800), UHSD14767800 (840682103800), PACS-IW-551UVN1 (840682103800), PACS-IW-551UVN2 (840682103800), UV1-154550926, DHOL19603374, DHOL19603375, PACS-IW-551UV (840682103800), PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, SFCS19667347, SFCS15961473, SFCS15961473, MHOG01806096, PACS-IW-166, PACS-IW-166T, MCT02277843, MCT02278145, PACS-IW-565, PACS-IWT-565, WGH00558334CTRL, WGH02372377PROX, WGH02372375BACK, 1-464783615, PACS-IW-389, BVH00558643, PACS-IW-348UV (840682103800), NRVM19609993UVT (840682103800), NRVM19611189UVPROXY (840682103800), PACS-IW-441, PACS-IW-441TUVSW, PACS-IW-402, PACS-IW-318, MINNETOHE, PACS-IW-253, PACS-IW-581UV, PACS-IW-370, PACS-IW-UVT370, VISOU02345023, VISOU02288781, 1-218291079, 1-103108035, MFHO14767332, PALMDALEM00558700, PALMDALEM01810788, PACS-IW-454, PACS-IW-406, 20101378UBSW, ILCC01373579 (840682103800), ILCC14580319 (840682103800), 516473UVSW (840682103800), JOHNTMA19732280T (840682103800), 1-182669905, NCDC20279342, CENTERFOR01627896, CENTERFOR16023960UVProxy, PACS-IW-176, PACS-IW-176UVTEST, PACS-IW-405, PACS-IW-336, NASONHOSP14898835, RRA01814001, MYRTLEHIL01444483, PSPC01815255, 1-283596904, HOOO20091140, GZMG02182469CNTRLR (840682103800), GZMG02287985 (840682103800), GZMG02288300 (840682103800), PACS-IW-556UV, URSA20025013, PACS-IW-431, 1-598891598, PACS-IW-230, INTERCOAST17594527UVProxy, MDHC16204735UVProxy, 201392UVSW, 505368UVBSW (840682103800), NNAR14767799 (840682103800), PACS-IW-479, PACS-IW-557 (840682103800), URS20583582 (840682103800), PACS-IWUV-481, PACS-IW-476, PACSIW476UVTEST, GGMC02349137, 1-486091448, 1-486091475, 1-750710672, SUC00558667, 1-802428413, 954688UVBSW100, PACS-IW-1511, KDH217192544, ACP00558109, PACS-IW-31Test1, PACS-IW-31Test, ACP01613226, 1-219095008, OKOS14767330, 918277CVUWBSW, CCA20759776SF, PACS-IW-487, QTHBL14767810UVPROXY, QTHBL14767809UVSFBK, QTHBL14767808UVSF1KO, QTHBL14767807UVSFSIM, QTHBL14767806UVSFVAL, QTHBL02256595, VCM02255583T, VCM01819618, VCM02255586TSP, VMC02255587NSP, BOJC00558520, PACS-IW-56, PACS-IW-225, 1-375705893, DDNI14776603, PACS-IW-129, DISSFHW01, 1-644600677, PACS-IW-154UV, FLMC14777071, NEWYORK01291738, OANT02035061, PACS-IW-424CTLR, PACS-IW-424UVN1, PACS-IW-424UVN2, VBHCP20497227, PACS-IW-2635, PREMI02182462, PREMI02182462, NORTHWEST01804127, HCIT4271649UW, AH4325SV01, AH5291PC02, AP6264PC01, AP6469PC01, AH0116SV03, AH0106SV0… (truncated, 7572 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
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

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 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

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

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

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

AKAZCACODEFLGAIAINLAMAMDMIMNMOMSMTNCNDNJNMNVNYOHOKORPASDTXUTWAWIWVWY
▸Full report

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

Recall #:
88526
Lot/product code:
2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2021

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.

ALARAZCACOCTDCDEFLGAGUHIIAIDILINKSKYLAMDMEMIMNMOMSNCNDNENJNVNYOHOKORPAPRRISCSDTNTXVAWAWIWVWY
▸Full report

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

Recall #:
88559
Lot/product code:
Catalog Number:B52699 Lot Number / UDI Code: 921491 / (01)15099590693183(17)201130(11)191201(10)921491; 921638 / (01)15099590693183(17)201231(11)200101(10)921638; 921631 / (01)15099590693183(17)210131(11)200201(10)921631; 921750 / (01)15099590693183(17)210131(11)200201(10)921750; 921805 / (01)15099590693183(17)210228(11)200229(10)921805; 921831 / (01)15099590693183(17)210331(11)200331(10)921831; 921943 / (01)15099590693183(17)210430(11)200430(10)921943; 922000 / (01)15099590693183(17)210531(11)200531(10)922000; 922039 / (01)15099590693183(17)210630(11)200630(10)922039; 922040 / (01)15099590693183(17)210731(11)200731(10)922040; 922062 / (01)15099590693183(17)210731(11)200731(10)922062; 922145 / (01)15099590693183(17)210831(11)200831(10)922145; 922146 / (01)15099590693183(17)210930(11)200930(10)922146; 922338 / (01)15099590693183(17)210930(11)200930(10)922338; 922440 / (01)15099590693183(17)211031(11)201031(10)922440; 922545 / (01)15099590693183(17)211031(11)201031(10)922545; 922547 / (01)15099590693183(17)211130(11)201130(10)922547; 922713 / (01)15099590693183(17)211231(11)201231(10)922713; 922714 / (01)15099590693183(17)211231(11)201231(10)922714; 922722 / (01)15099590693183(17)220131(11)210131(10)922722; 922897 / (01)15099590693183(17)220131(11)210131(10)922897; 124235 / (01)15099590693183(17)220228(11)210228(10)124235; 124339 / (01)15099590693183(17)220228(11)210228(10)124339; 922898 / (01)15099590693183(17)220228(11)210228(10)922898; 124340 / (01)15099590693183(17)220331(11)210331(10)124340; 124348 / (01)15099590693183(17)220430(11)210430(10)124348; 124353 / (01)15099590693183(17)220430(11)210430(10)124353; 124688 / (01)15099590693183(17)220430(11)210430(10)124688; 124354 / (01)15099590693183(17)220531(11)210531(10)124354; 124355 / (01)15099590693183(17)220630(11)210630(10)124355; 124356 / (01)15099590693183(17)220630(11)210630(10)124356; 124357 / (01)15099590693183(17)220630(11)210630(10)124357;
Recalling firm:
Beckman Coulter 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.

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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