BIGNOPE
Ko-fi

Recalls affecting New Jersey

Data last updated: September 8, 2026 at 1:13 PM UTC

17,137 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 April 23, 2018

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.

The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.

Full report

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

Recall #:
79887
Lot/product code:
Serial Numbers: 483731, 483930, 483992, 484013, 492055, 492368, 501157, 501177, 501178, 501187, 501191, 501200, 501202,  501205,  501207,  501268,  501285,  501364,  501368,  501370,  501376,  501385,  501386,  501387,  501432, 501435, 501440, 501443, 501444, 501445, 501466, 501479, 501488, 501490, 501491, 501495, 501503, 501508, 501509, 501519, 501522, 501523, 501526, 501535, 501560, 504522, 504531, 504535, 504540,  504753,  504972,  504990,  505025,  90472671,  90488584
Recalling firm:
Tandem Diabetes Care Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled April 27, 2018

Vans gluten free Original 6 WAFFLES NET WT 9 OZ (255g) INGREDIENTS:***VAN'S GLUTEN FREE MIX (BROWN RICE FLOUR, POTATO STARCH, RICE FLOUR, SOY FLOUR),***RICE FLOUR,***SUNFLOWER AND/OR SOY LECITHIN***CONTAINS: SOY DISTRIBUTED BY: VAN'S INTERNATIONAL FOODS SAN DIEGO, CA 92154 UPC 0 89947 30206 4

The firm was notified that they failed to include the allergens milk & wheat in their ingredient statement.

Full report

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

Recall #:
F-1475-2018
Lot/product code:
Lot Code #A640234710 WL2, BEST BY AUG 22, 2018
Recalling firm:
Tyson Foods Discovery Center
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 2, 2018

AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

Full report

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

Recall #:
80652
Lot/product code:
Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
Recalling firm:
Stryker Neurovascular
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 2, 2018

Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.

Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.

ALL 50 STATES
Full report

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

Recall #:
80056
Lot/product code:
ALL SERIAL NUMBERS  UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement  1403: 00888707000116, 00888707000475  1407: '00888707000291, '00888707000727, '00888707000710,   00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472  1420: '00888707000420, '00888707000437, '00888707002660  (b) 1435: '00888707000109  1440: '00888707000260, '00888707001885, '00888707001496,  '00888707002745  (c) 1425: '00888707000093  1430: '00888707000307, '00888707000826, '00888707000833,  '00888707000840, '00888707000857, '00888707000871, '00888707000864,  '00888707000888, '00888707000901, '00888707000505, '00888707000895,  '00888707000918, '00888707001489, '00888707001779, '00888707001786,  '00888707001793, '00888707001809, '00888707001816, '00888707001823,  '00888707001830, '00888707001847, '00888707001854, '00888707001861,  '00888707001878, '00888707002738, '00888707002769, '00888707002776,  '00888707002783, '00888707002790, '00888707002806, '00888707004817  (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653,  '00888707000376
Recalling firm:
Heartware
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 3, 2018

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179

Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.

Full report

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

Recall #:
80003
Lot/product code:
All Serial Numbers distributed from 03/06/2012 to 04/26/2018
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 17, 2018

The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.

ALL 50 STATES
Full report

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

Recall #:
80691
Lot/product code:
UDI Number: 00886874114193. Serial Number: SK1703.
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L0711KX, N7L1141KX, N7M0853KX, N8B0419KX, N7L0912KX, N7M0241KX, N8A0271KX, N8C0012KX, N7L0973KX, N7M0353KX, N8A0684KX, N8C0143KX, N7L1038KX, N7M0366KX, N8A0924KX, N7M0996KX, N7L0807KX, N7M0548KX, N8A1143KX, N8A0173KX,  N7L1050KX, N7M0617KX, N8B0161KX, N8A0488KX, N7L1125KX, N7M0745KX, N8B0283KX & N8C0136KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X & N8B0993X
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L0521KX, N7M0047KX, N7M0592KX, N7M1001KX, N7L0975KX, N7M0434KX, N7M0683KX, N8A0203KX, N7L1057KX, N7M0528KX, N7M0937KX, N8A0677KX, N7L1098KX, N7M0529KX, N7M0949KX, N8C0144KX & N7L1099KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7M0045KX, N7M0398KX, N8A0523KX, N8B0088KX, N7M0070KX, N8A0255KX & N8B0080KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L0974KX, N7M0486KX, N7M0762KX & N8A0363KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L0551KX & N7M0877KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N8A0146KX, N8A0327KX & N8A0907KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L0823KX, N8A0799KX & N8B1008KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L1019X, N7M0129X & N7L0734X
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L1041KX & N8A0199KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L0915X & N7M0468X
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L1163X & N7M0156X
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7G0756KX & N7L0819KX
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 22, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

ALL 50 STATES
Full report

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

Recall #:
80423
Lot/product code:
N7L1049X & N7M0723X
Recalling firm:
COVIDIEN MEDTRONIC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 23, 2018

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.

ALL 50 STATES
Full report

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

Recall #:
80769
Lot/product code:
00868579000209
Recalling firm:
Ortho Kinematics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 25, 2018

GE Healthcare CARESCAPE Monitor B650

When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

ALL 50 STATES
Full report

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

Recall #:
80262
Lot/product code:
Serial Numbers:  SEW13497373HA SEW13497374HA SEW13497375HA SEW13497376HA SEW13508068HA SEW12494591HA SEW14280294HA SEW14280298HA SEW14289769HA SEW14289777HA SK416341018HA SK416341019HA SK416341026HA SEW12494422HA SEW12494425HA SEW12494435HA SEW12494584HA SEW12494585HA SEW12494592HA SEW12494593HA SEW12494596HA SEW12494598HA SEW12494619HA SEW12494621HA SEW12494622HA SEW12494625HA SEW12494626HA SEW12504918HA SEW12504923HA SEW12504940HA SEW12504942HA SEW12504944HA SEW12504954HA SEW14278996HA SEW14279002HA SEW14279003HA SEW14279005HA SK416061047HA SK416061048HA SK416061088HA SK416081102HA SK416461063HA SK416461092HA SEW13109786HA SEW12059577HA SEW12059583HA SEW12059587HA SEW12059589HA SEW12059592HA SEW12059593HA SEW12059594HA SEW12059596HA SEW12059597HA SEW12059598HA SEW12059599HA SEW12059601HA SEW13275956HA SEW13276028HA SEW13276029HA SEW13275967HA SEW13276066HA SEW13276073HA SEW13286164HA SEW13286175HA SEW13286183HA SK415491246HA SK415491249HA SK415491253HA SK415491257HA SK415491259HA SK415491264HA SK415491265HA SQC17490035HA SQC17490038HA SQC17490039HA SQC17490040HA SQC17490042HA SEW15134264HA SEW15134269HA SEW15134270HA SK415211108HA SK415211110HA SK415211116HA SK415221002HA SK415221006HA SK415361118HA SK415361119HA SK415361120HA SK415361121HA SK415361122HA SK415361123HA SK416041059HA SK416051085HA SK416051119HA SK416041053HA SK416041054HA SK416041062HA SK416041063HA SK416041065HA SK415491254HA SK415521029HA SK415531048HA SK416011088HA SK416011113HA SK416501112HA SK416501119HA SK416501122HA SK417051035HA SK417051036HA SK417051038HA SK417051099HA SK417051100HA SK417051118HA SK417051121HA SK417051122HA SK417051125HA SK417051126HA SK417051130HA SK417051131HA SK417051139HA SK417051144HA SK417051145HA SK417051149HA SK417051150HA SK417051151HA SK417051152HA SK417051153HA SK417051154HA SK417051157HA SK417061002HA SK417061023HA SK417061024HA SK417061025HA SEW13508579HA SEW13369186HA SEW13369234HA SEW13369245HA SEW13369246HA SEW13369249HA SEW13369251HA SEW13369252HA SEW13369254HA SEW13369255HA SEW13369256HA SEW14381680HA SEW15166221HA SEW15166222HA SEW15166223HA SEW15166224HA SEW15166226HA SEW15166230HA SEW15166231HA SEW15166235HA SEW15166236HA SEW15166237HA SEW14063178HA SEW14062864HA SEW14062865HA SEW14062927HA SEW14063174HA SEW14063175HA SEW14063176HA SEW14063179HA SEW14062866HA SEW14235956HA SEW14235957HA SEW14235958HA SEW14235993HA SEW14235994HA SEW14235995HA SEW14246223HA SK416051106HA SK416051113HA SK416051114HA SK416051115HA SEW11202291HA SK416121077HA SK416121083HA SEW12245068HA SEW12245071HA SEW12245072HA SEW12245074HA SEW12245075HA SEW12245076HA SEW12482932HA SQC18150040HA SQC18150042HA SK416321071HA SK416321073HA SK416321075HA SK416321076HA SEW13317664HA SQC17500211HA SQC17500212HA SQC17500213HA SQC17500214HA SQC17500215HA SQC17500216HA SQC17500217HA SQC17500218HA SQC17500219HA SQC17500220HA SQC17500221HA SQC17500222HA SQC17500224HA SQC17500225HA SQC17500226HA SQC17500228HA SQC17500230HA SQC17500234HA SQC17500235HA SEW14063243HA SQC18010001HA SK417081005HA SEW13369260HA SEW13369277HA SEW13379768HA SEW13379778HA SEW13379779HA SEW13379780HA SEW13379782HA SEW13379784HA SEW13379790HA SEW13379791HA SEW14031040HA SEW14031041HA SEW14031042HA SEW14031044HA SEW14031045HA SEW14031046HA SEW14031047HA SEW14031060HA SEW14031061HA SEW14031062HA SEW14031066HA SEW14041261HA SEW14041262HA SEW14041263HA SEW14041264HA SEW14041267HA SEW14041268HA SEW14041269HA SEW14041271HA SEW14041282HA SEW14041283HA SEW14041284HA SEW14041286HA SEW14041287HA SEW14041289HA SEW14041290HA SEW14041291HA SEW14063210HA SEW14105484HA SEW14105968HA SEW14105969HA SEW14116795HA SEW14127301HA SEW14127307HA SEW14127308HA SEW14127312HA SEW14127313HA SEW14127314HA SEW14127315HA SEW14127316HA SEW14127317HA SEW14127318HA SEW14127319HA SEW14127320HA SEW14127321HA SEW14127322HA SEW14127323HA SEW14127324HA SEW14127325HA SEW14127326HA SEW14127327HA SEW14127328HA SEW14127329HA SEW14127330HA SEW14127331HA SEW14127332HA SEW14127333HA SEW14127334HA SEW14127335HA SEW14127631HA SEW14127632HA SEW14127633HA SEW14127634HA SEW14127635HA SEW14127636HA SEW14127637HA SEW14127638HA SEW14127639HA SEW14127863HA SEW14127864HA SEW14127865HA SEW14127866HA SEW14127867HA SEW13379789HA SEW13379793HA SQC17450282HA SQC17450283HA SQC17450284HA SQC17450285HA SQC17450287HA SQC17450289HA SQC17450292HA SQC17450293HA SEW12388960HA SEW12388971HA SEW12389025HA SEW12389026HA SEW12494289HA SEW12494291HA SEW12494292HA SEW12494293HA SEW12494294HA SEW12494296HA SEW12494316HA SEW12494319HA SEW12494320HA SEW12494321HA SEW12494323HA SEW12494324HA SEW12494325HA SEW12494328HA SEW12494559HA SEW12494561HA SEW12494562HA SEW12494568HA SEW12494603HA SEW12494605HA SEW12494606HA SEW12494607HA SEW12494608HA SEW12494610HA SEW12494611HA SEW12494612HA SEW12494613HA SEW12494615HA SEW13265672HA SEW13265673HA SEW13265674HA SEW13275965HA SK416071199HA SK416071202HA SK416071205HA SK416071206HA SK416071207HA SK416071208HA SK416071209HA SK416071210HA SK416071211HA SK416071212HA SK416071213HA SK416071214HA SK416071225HA… (truncated, 969250 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare Finland Oy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 30, 2018

Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.

When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.

Full report

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

Recall #:
81026
Lot/product code:
MODEL SERIAL NUMBER SID MEXL-1504/U4 U4A12Z2020 30005914 MEXL-1504/T4 S4D1132069 339325 MEXL-1504/S4 S4A1032017 326165 MEXL-1504/U4 U4A1312023 30000547 MEXL-1504/S4 S4A1032019 327601 MEXL-1504/U4 U4A1312024 30002325 MEXL-1504/T4 S4D1152082 330035 MEXL-1504/S4 S4A1082040 330134 MEXL-1504/A4 A4A11Z2011 346866 MEXL-1504/U4 U4A1282003 356105 MEXL-1504/U4 U4A1322025 30009003 MEXL-1504/U4 U4B1442070 30012516 MEXL-1504/U4 U4A1352035 389636 MEXL-1504/U4 U4B1552097 30010318 MEXL-1504/U4 U4A12X2010 351817 MEXL-1504/S4 S4C1112065 330381 MEXL-1504/S4 S4C1112064 334599 MEXL-1504/A4 A4A11Z2009 352039 MEXL-1504/S4.004 S4A1072033 30025756 MEXL-1504/S4 S4A09Y2002 345231 MEXL-1504/U4.004 U4A1282002 30027784 MEXL-1504/U4.004 U4A1382047 30036224 MEXL-1504/S3 S3A0972030 312421 MEXL-1504/U4 U4A12X2011 345074 MEXL-1504/S4 S4C1112061 337212 MEXL-1504/U4 U4A13X2054 30011038 MEXL-1504/A4 A4A1222015 351023 MEXL-1504/U4 U4A1322026 337071 MEXL-1504/U4 U4B1642106 30008395 MEXL-1504/A4 A4A1222017 347963 MEXL-1504/S4 S4A10X2047 315713 MEXL-1504/S3 S3A08Z2019 303586 MEXL-1504/U4 U4B1522092 358163 MEXL-1504/A4 A4A11X2004 30018147 MEXL-1504/T4 S4D1132074 347260 MEXL-1504/U4 U4B1422064 30021502 MEXL-1504/U4 U4A1312022 30004266 MEXL-1504/U4 U4A1352036 30001882 MEXL-1504/U4 U4A1372046 337083 MEXL-1504/T4 S4D1142076 341529 MEXL-1504/U4 U4A13Z2057 30005810 MEXL-1504/A4 A4A11Z2010 349167 MEXL-1504/U4 U4A1292007 349175 MEXL-1504/U4 U4B1632105 366015 MEXL-1504/U4 U4B1492081 376523 MEXL-1504/U4 U4A1352037 389696 MEXL-1504/U4 U4A1312021 353532 MEXL-1504/U4 U4B1482077 392326 MEXL-1504/A4 A4A11X2002 333633 MEXL-1504/U4 U4B14Y2082 30018555 MEXL-1504/U4 U4A13X2051 325434 MEXL-1504/A4 A4A11Y2006 350868 MEXL-1504/A4 A4A1252024 356295 MEXL-1504/U4 U4B1532094 30027785 MEXL-1504/U4 U4B1652107 30009792 MEXL-1504/S3 S3A0922023 299545 MEXL-1504/U4 U4A1382049 30007016 MEXL-1504/U4 U4A12Z2014 356808 MEXL-1504/S3 S3A0892009 301747 MEXL-1504/A4 A4A11X2003 324905 MEXL-1504/S3.004 S3A0882007 30024991 MEXL-1504/T4 S4D1132073 339838 MEXL-1504/U4 U4A1362039 393723 MEXL-1504/U4 U4B1462074 356287 MEXL-1504/U4 U4B1522091 30006245 MEXL-1504/U4 U4A1342033 30004737 MEXL-1504/U4 U4A1342034 30001465 MEXL-1504/U4 U4A12X2009 354860 MEXL-1504/U4 U4A1412059 383292 MEXL-1504/U4 U4A1412063 30003291 MEXL-1504/U4 U4A1282004 356881 MEXL-1504/U4 U4A1352038 30004544 MEXL-1504/U4 U4A12Y2013 359834 MEXL-1504/U4 U4B14Z2086 30023668 MEXL-1504/U4 U1A13Z2001 30007654 MEXL-1504/S3 S3A0942027 314575 MEXL-1504/U4 U4A1272001 357343 MEXL-1504/U4 U4A1292006 384206 MEXL-1504/S4 S4A1042023 308445 MEXL-1504/S3 S3A08Z2016 308437 MEXL-1504/A4 A4A11X2001 342766 MEXL-1504/U4 U4B1512089 30006322 MEXL-1504/A4 A4A1212012 352641 MEXL-1504/U4 U4A1342029 314591 MEXL-1504/T4 S4E1192095 340919 MEXL-1504/U4 U4A1362041 30004910 MEXL-1504/U4 U4A12Y2012 356816 MEXL-1504/U4 U4A1382050 30006997 MEXL-1504/A4 A4A1242021 345363 MEXL-1504/S4 S4A1092046 333104 MEXL-1504/A4 A4A1252023 348078 MEXL-1504/U4 U4B15Y2102 30002102 MEXL-1504/U5 U5B15Z2001 30002103 MEXL-1504/T4 S4D1132071 328690 MEXL-1504/U4 U4A13Y2056 30004937 MEXL-1504/S4 S4A1092043 310631 MEXL-1504/U4 U4A1322027 394526 MEXL-1504/U4 U4B1522093 30007522 MEXL-1504/U4 U4A1412061 389344 MEXL-1504/S3 S3A0872005 298422 MEXL-1504/U4 U4A12Z2017 357400 MEXL-1504/A4 A4A1212013 349118 MEXL-1504/U4 U4B1482076 30020797 MEXL-1504/U4 U4B1552098 30012104 MEXL-1504/A4 A4A1222019 352146 MEXL-1504/S4 S4A1052025 324327 MEXL-1504/U4 U4A1292008 356568 MEXL-1504/A4 A4A1222016 340950 MEXL-1504/U4 U4B1432067 30007279 MEXL-1504/U4 U4A1362042 357418 MEXL-1504/S4 S4A1092045 333047 MEXL-1504/U4 U4B1452071 30009112 MEXL-1504/A4 A4A1242022 351429 MEXL-1504/A4 A4A1262025 394677 MEXL-1504/S4 S4A1082036 331306 MEXL-1504/S4 S4C1112060 340539 MEXL-1504/T4 S4D1152081 342436 MEXL-1504/S4 S4A09X2001 317842 MEXL-1504/U4 U4A12Z2019 356063 MEXL-1504/T4.004 S4D1142079 372281 MEXL-1504/U4 U4B1512090 30011831 MEXL-1504/U4 U4A13X2055 372615 MEXL-1504/U4 U4A1362044 30008519 MEXL-1504/A4 A4A11X2005 343723 MEXL-1504/U4 U4B15X2101 30008684 MEXL-1504/S4 S4A1072032 316471 MEXL-1504/U4 U4B1482079 377483 MEXL-1504/U4 U4B1582100 30004842 MEXL-1504/S4 S4A1022013 313254 MEXL-1504/S4 S4A1022014 313262 MEXL-1504/U4 U4B1612103 30029397 MEXL-1504/T4 S4D1132070 337303 MEXL-1504/U4 U4A1382048 30003156 MEXL-1504/U4 U4B1612104 385256 MEXL-1504/T4 S4E1182093 342311 MEXL-1504/U4 U4A13X2052 380285 MEXL-1504/U4 U4A12Z2015 356840 MEXL-1504/U4 U4B1452072 369092 MEXL-1504/U4 U4B1452073 30007850 MEXL-1504/U4 U4B1582099 30006070 MEXL-1504/S4 S4A1022015 326512 MEXL-1504/U4 U4B14Y2084 365309 MEXL-1504/S3 S3A08Y2013 292490 MEXL-1504/S4 S4B10Z2058 336701 MEXL-1504/S3 S3A09X2039 351542 MEXL-1504/S4 S4A1092044 308189 MEXL-1504/A4 A4A1222018 345587 MEXL-1504/A4.007 A4A1222014 392554 MEXL-1504/T4 S4D1172089 345140 MEXL-1504/U4 U4B1432066 30008575 MEXL-1504/U4 U4B1442069 30007942 MEXL-1504/S4 S4A1082041 329656 MEXL-1504/S3 S3A09X2041 311514 MEXL-1504/A4 A4A11Y2008 348169 MEXL-1504/S3 S3A08Y2012 311506 MEXL-1504/S4 S4A1062030 311522 … (truncated, 8057 characters total — see the official FDA record for the full value)
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 30, 2018

FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."

Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.

ALL 50 STATES
Full report

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

Recall #:
80757
Lot/product code:
Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 4, 2018

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

ALL 50 STATES
Full report

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

Recall #:
81073
Lot/product code:
Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)