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Recalls affecting Hawaii

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

16,268 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 24, 2026

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.

ALL 50 STATES
Full report

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

Recall #:
98932
Lot/product code:
UDI-DI 00195278617644 Serial numbers SU325232838SA SU325032272SA SU325293027SA SU325222794SA SU325122553SA SU325363223SA SU325483517SA SU325152591SA SU325363222SA SU325483514SA SU325272955SA SU325222809SA SU325092421SA SU325272941SA SU325272944SA SU325393292SA SU325393293SA SU325393296SA SU325443415SA SU325303053SA SU325353201SA SU324512241SA SU325032260SA SU325433377SA SU325242899SA SU325242900SA SU325192689SA SU325172624SA SU325172626SA SU325172630SA SU325333173SA SU325383266SA SU324502188SA SU325112523SA SU325112524SA SU325192719SA SU325313091SA SU325403321SA SU325323101SA SU325323103SA SU324502193SA SU324502203SA SU324502209SA SU324502211SA SU325272960SA SU325272962SA SU325252906SA SU325433376SA SU325473497SA SU324502191SA SU324502204SA SU324502206SA SU324502207SA SU325293013SA SU325293014SA SU325293015SA SU325293016SA SU325383265SA SU324482168SA SU325122538SA SU325122540SA SU325192691SA SU325192692SA SU325192708SA SU324492172SA SU325172632SA SU325182669SA SU325323135SA SU325323137SA SU325503570SA SU326033668SA SU325172613SA SU325052318SA SU325373241SA SU325443399SA SU325222802SA SU325222803SA SU325222805SA SU325293025SA SU325272954SA SU324512242SA SU325132576SA SU325172612SA SU325172614SA SU325172640SA SU325172641SA SU325192693SA SU325252910SA SU325092412SA SU325333171SA SU325122543SA SU325182687SA SU325242868SA SU325242870SA SU325473487SA SU326023667SA SU325062342SA SU325473493SA SU325252909SA SU325282987SA SU325293020SA SU325473494SA SU325473495SA SU326033696SA SU326033700SA SU326033701SA SU325463458SA SU325463461SA SU324502190SA SU325042274SA SU325122539SA SU325122541SA SU325192707SA SU325192710SA SU325192711SA SU325192717SA SU325192721SA SU325293017SA SU325293018SA SU325343185SA SU325343186SA SU325493541SA SU325493543SA SU325493549SA SU325052306SA SU325222771SA SU325222777SA SU325222778SA SU325222783SA SU325222797SA SU325493536SA SU325493539SA SU325313066SA SU325313067SA SU325313068SA SU325333167SA SU325333168SA SU325333170SA SU325403315SA SU325403318SA SU325112516SA SU325443403SA SU325122547SA SU325473486SA SU325303059SA SU325313095SA SU325313096SA SU325313098SA SU325433378SA SU325513591SA SU325353194SA SU325192694SA SU325192697SA SU325483518SA SU325252905SA SU325493558SA SU325222768SA SU324492183SA SU324492184SA SU324502185SA SU325503568SA SU325513589SA SU325282989SA SU325282991SA SU325282992SA SU325463466SA SU325473496SA SU325182655SA SU325032267SA SU325313075SA SU325413336SA SU325282996SA SU325172643SA SU325042285SA SU325293024SA SU325523609SA SU325523610SA SU325523611SA SU325363217SA SU325363219SA SU325112508SA SU325162594SA SU325072361SA SU325072362SA SU325373248SA SU325202734SA SU325443397SA SU325443398SA SU326053735SA SU324492181SA SU325192700SA SU325222806SA SU325443392SA SU325242869SA SU325242887SA SU325242890SA SU325052292SA SU325052295SA SU325072383SA SU325072384SA SU325092414SA SU325092417SA SU325152592SA SU325313089SA SU325313090SA SU325403330SA SU325423361SA SU325423366SA SU325042284SA SU325383253SA SU325172609SA SU325182650SA SU325323128SA SU325293021SA SU325132574SA SU325142587SA SU325142589SA SU325192701SA SU325192703SA SU325222786SA SU325293023SA SU325282986SA SU325192715SA SU325272957SA SU325272958SA SU326063754SA SU325473492SA SU325092409SA SU325393290SA SU325463479SA SU325463480SA SU325463459SA SU326033702SA SU325182657SA SU325282981SA SU325423364SA SU325182685SA SU325232811SA SU325172595SA SU325172607SA SU325072352SA SU325092423SA SU325252907SA SU325363225SA SU325072360SA SU325293031SA SU325463460SA SU325463462SA SU325222784SA SU325222787SA SU324482166SA SU325042281SA SU325323125SA SU325323126SA SU325423363SA SU326053734SA SU325202747SA SU325202749SA SU325232816SA SU325323121SA SU325293033SA SU325042273SA SU325192716SA SU325112515SA SU325112520SA SU325182670SA SU325473488SA SU325182646SA SU325363213SA SU325363218SA SU325383254SA SU325042278SA SU325252911SA SU325052320SA SU325242895SA SU325373245SA SU326023636SA SU325052315SA SU325433368SA SU325453442SA SU325453443SA SU325513596SA SU325463457SA SU325242894SA SU325363229SA SU325363235SA SU325463454SA SU325463455SA SU325463456SA SU325363220SA SU325313081SA SU325443393SA SU325353200SA SU326063745SA SU325222801SA SU325042275SA SU325433375SA SU325172616SA SU325172617SA SU324512243SA SU324512244SA SU325282983SA SU325313092SA SU325032266SA SU325202743SA SU325092416SA SU324512248SA SU326033691SA SU325102453SA SU325102455SA SU325102456SA SU325112482SA SU325112484SA SU325112486SA SU325112488SA SU325112489SA SU325112509SA SU325112512SA SU325112517SA SU325112518SA SU325112519SA SU325202763SA SU325222769SA SU325242871SA SU325282995SA SU325313076SA SU325393285SA SU325333154SA SU325333156SA SU325473504SA SU325293034SA SU325293035SA SU325232832SA SU325443390SA SU325142586SA SU326043719SA SU325483507SA SU325483509SA SU325483511SA SU325463473SA SU325092443SA SU326033672SA SU325172642SA SU325182660SA SU325523616SA SU325393300SA SU325272951SA SU325313097SA SU325443389SA SU326063755SA SU326063756SA SU326063757SA SU325323106SA SU325323109SA SU32522… (truncated, 25726 characters total — see the official FDA record for the full value)
Recalling firm:
GE Medical Systems Information Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

ALL 50 STATES
Full report

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

Recall #:
98797
Lot/product code:
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Recalling firm:
BERLIN HEART GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

ALL 50 STATES
Full report

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

Recall #:
98938
Lot/product code:
Serial #/Sales Order #: SS920500004SA, SS920500005SA, SS920500003SA, SS920500006SA, SS921120011SA, SS921120019SA, SS921120015SA.
Recalling firm:
GE Medical Systems Information Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

ALL 50 STATES
Full report

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

Recall #:
98938
Lot/product code:
UDI (01)00840682144773(10)v5.0.2R1C1, Serial Number or Sales Order Number: SS924160026SA, SS921080002SA, SS923080001SA, SS923080006SA, SS922460008SA, SS921320004SA, SS921320010SA, SS921320012SA, SS922120001SA, SS921210005SA, SS921060024SA, SS921060026SA, SS924290077SA, SS923290011SA, SS923290012SA, SS923290013SA, SS923290014SA, SS921520004SA, SS922080001SA, SS922080002SA, SS922120002SA, SS922120003SA, SS924200022SA, SS924450085SA, SS924220065SA, SS921210002SA, SS921210003SA, SS924220066SA, SS924050001SA, SS922170005SA, SS924160027SA, SS924160028SA, SS924160029SA, SS924160031SA, SS924160032SA, SS924160033SA, SS921300003SA, SS921420015SA, SS921420016SA, SS921520002SA, SS920520004SA, SS922250001SA, SS923510002SA, SS923510003SA, SS924160023SA, SS924170017SA, SS924200031SA, SS924200032SA, SS924090011SA, SS924090016SA, SS924090018SA, SS924090020SA, SS924090021SA, SS924090024SA, SS924140003SA, SS924140006SA, SS924140011SA, SS924140012SA, SS924140014SA, SS924170006SA, SS924170007SA, SS924170008SA, SS924170009SA, SS924170010SA, SS924170011SA, SS924170012SA, SS924170013SA, SS924170014SA, SS924170015SA, SS924170016SA, SS921110009SA, SS921420013SA, SS922170004SA, SS922340005SA, SS922290002SA, SS923220003SA, SS923290008SA, SS924020004SA, SS921040002SA, SS921050002SA, SS921060023SA, SS921060025SA, SS921060020SA, SS921060022SA, SS921060016SA, SS921060017SA, SS921060018SA, SS921060021SA, SS921110004SA, SS921110001SA, SS921240007SA, SS920490011SA, SS924430083SA, SS924050023SA, SS924060001SA, SS922080004SA, SS922080005SA, SS922080006SA, SS923240002SA, SS923520001SA, SS922120004SA, SS922390002SA, SS923400001SA, SS922340008SA, SS922340009SA, SS922340010SA, SS922020001SA, SS923230004SA, SS923230005SA, SS923230006SA, SS923470001SA, SS923470002SA, SS923470003SA, SS923470006SA, SS923470007SA, SS923480001SA, SS924060011SA, SS922240002SA, SS924060012SA, SS924070006SA, SS924070010SA, SS921110005SA, SS921180006SA, SS921420001SA, SS921470002SA, SS921470004SA, SS922250003SA, SS922340004SA, SS922460004SA, SS922460007SA, SS924060008SA, SS924060009SA, SS924060010SA, SS922130001SA, SS921300001SA, SS922410002SA, SS920500009SA, SS920500008SA, SS921240009SA, SS923430002SA, SS922010003SA, SS923370001SA, SS924050013SA, SS924050025SA, SS924050009SA, SS924050010SA, SS924050017SA, SS924290078SA, SS920430005SA, SS920430006SA, SS920460004SA, SS921140001SA, SS924040005SA, SS920450002SA, SS920450003SA, SS923230017SA, SS924070007SA, SS924070005SA, SS924090013SA, SS924090014SA, SS923250002SA, SS923250003SA, SS920520001SA, SS921180010SA, SS922340011SA, SS920490001SA, SS923030004SA, SS923240001SA, SS924140001SA, SS923110002SA, SS924040006SA, SS922310001SA, SS921080001SA, SS924050007SA, SS921180008SA, SS923520002SA, SS922340006SA, SS924050016SA, SS924050012SA, SS924150001SA, SS924150002SA, SS921320001SA, SS921320002SA, SS921320003SA, SS921320006SA, SS921320007SA, SS921320008SA, SS921320009SA, SS921320011SA, SS921300005SA, SS921240001SA, SS920450001SA, SS921300006SA, SS923450001SA, SS921520003SA, SS924130001SA, SS924130003SA, SS922410003SA, SS922460003SA, SS921520008SA, SS924130004SA, SS920430001SA, SS920510003SA, SS920510007SA, SS920510010SA, SS923070001SA, SS921300002SA, SS924070009SA, SS922040008SA, SS920510009SA, SS924050003SA, SS922090001SA, SS923290007SA, SS923300001SA, SS923300002SA, SS924050006SA, SS924050011SA, SS924050008SA, SS922080003SA, SS923030003SA, SS921130001SA, SS921150001SA, SS921150002SA, SS921460009SA, SS921320005SA, SS922180001SA, SS920490002SA, SS921460007SA, SS924050005SA, SS925270092SA, SS925270093SA, SS925270095SA, SS925270094SA, SS924160022SA, SS924050015SA, SS925330096SA, SS920430002SA, SS920430004SA, SS924070015SA, SS925260090SA, SS925260091SA, SS921460005SA, SS922250002SA, SS923030002SA, SS923030006SA, SS924050014SA, SS924430084SA, SS921470005SA, SS921210001SA, SS921210007SA, SS921210008SA, SS921210009SA, SS921210010SA, SS924050004SA, SS923230026SA, SS921420017SA, SS921150003SA, SS921050001SA, SS924070003SA, SS924070004SA, SS922120005SA, SS922250004SA, SS924200024SA, SS924200025SA, SS924200026SA, SS924200027SA, SS924200028SA, SS924200029SA, SS924200030SA, SS921110003SA, SS923110003SA, SS922390001SA, SS922290001SA, SS924140004SA, SS923200001SA, SS921150005SA, SS924090017SA, SS923290006SA, SS921240004SA, SS921240005SA, SS921240006SA, SS921240010SA, SS921460003SA, SS921420018SA, SS921420019SA, SS924170004SA, SS924170005SA, SS924170003SA, SS924090015SA, SS924140016SA, SS924090027SA, SS924090026SA, SS924090023SA, SS924090006SA, SS922040001SA, SS924090012SA, SS921110006SA, SS924170001SA, SS924170002SA, SS924090025SA, SS924090019SA, SS923070002SA, SS923070003SA, SS922040006SA, SS923400003SA, SS921300007SA, SS922380001SA, SS921460001SA, SS921460004SA, SS920430003SA, SS921250001SA, SS923220001SA, SS922050001SA, SS922050002SA, SS922050003SA, SS922050004SA, SS924200023SA, SS924010001SA, SS924070011SA, SS920500007SA, SS920500010SA, SS922010001SA, SS923320001SA, SS923230011SA, SS923230012SA, SS923230013SA, SS923230015SA, SS923230016SA, SS92… (truncated, 7215 characters total — see the official FDA record for the full value)
Recalling firm:
GE Medical Systems Information Technologies Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 24, 2026

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.

Not guaranteed to be germ-free: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

ALL 50 STATES
Full report

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

Recall #:
D-0519-2026
Lot/product code:
Lot: 45011002, Exp. 03/31/2027
Recalling firm:
Teva Pharmaceuticals USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

ALL 50 STATES
Full report

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

Recall #:
98938
Lot/product code:
UDI (01)00195278512390(10)APv6.0.0.5, Serial Number or Sales Order Number: SUV25423440TA, SUV25423443TA, SUV25423444TA, SUV25423445TA, SUV25423446TA, SUV25423447TA, SUV25493641TA, SUV26093921TA, SUV26093922TA, SUV26093923TA, SUV26093924TA, SUV26093925TA, SUV26093926TA, SUV26093927TA, SUV26093928TA, SUV26093929TA, SUV26093930TA, SUV26093931TA, SUV26093932TA, SUV26033814TA, SUV26033815TA, SUV26033816TA, SUV26033817TA, SUV26033818TA, SUV26033819TA, SUV26033820TA, SUV25112833TA, SUV25112834TA, SUV25202954TA, SUV24251609SA, SUV24251610SA, SUV24251611SA, SUV24251612SA, SUV24251613SA, SUV24251614SA, SUV24251615SA, SUV24251616SA, SUV24141336SA, SUV23260213SA, SUV23260214SA, SUV23260215SA, SUV23260216SA, SUV23260217SA, SUV24241569SA, SUV24241570SA, SUV24241574SA, SUV25122865TA, SUV25122866TA, SUV25122867TA, SUV25122868TA, SUV26083897TA, SUV23510727SA, SUV23510728SA, SUV23510729SA, SUV23510730SA, SUV23510731SA, SUV23510732SA, SUV23510733SA, SUV23510734SA, SUV23510735SA, SUV23510736SA, SUV25112811TA, SUV25112812TA, SUV25102746TA, SUV25102747TA, SUV25102748TA, SUV23400387SA, SUV23400388SA, SUV23400389SA, SUV23400390SA, SUV24091167SA, SUV24091168SA, SUV24091169SA, SUV24091170SA, SUV24091171SA, SUV24091172SA, SUV24091173SA, SUV24091174SA, SUV23460644SA, SUV23460645SA, SUV23460646SA, SUV23460647SA, SUV25283133TA, SUV23440442SA, SUV23440443SA, SUV23440444SA, SUV23440445SA, SUV23440446SA, SUV23440447SA, SUV23280235SA, SUV23410401SA, SUV25132875TA, SUV25243037TA, SUV25243038TA, SUV25243039TA, SUV23430413SA, SUV23430414SA, SUV24071051SA, SUV25233018TA, SUV24241571SA, SUV24241572SA, SUV24091163SA, SUV25493668TA, SUV25493669TA, SUV25493670TA, SUV25493671TA, SUV25493672TA, SUV24060959SA, SUV24060960SA, SUV24060961SA, SUV24060962SA, SUV24060963SA, SUV24060964SA, SUV24060965SA, SUV24060966SA, SUV24060967SA, SUV24060968SA, SUV24060969SA, SUV24030868SA, SUV24030869SA, SUV24030870SA, SUV24030871SA, SUV24030872SA, SUV24030873SA, SUV24030874SA, SUV24030875SA, SUV24030876SA, SUV24030877SA, SUV24030878SA, SUV24030879SA, SUV24030880SA, SUV24442331SA, SUV23310271SA, SUV26043825TA, SUV26043826TA, SUV26043827TA, SUV26043828TA, SUV26043829TA, SUV26043830TA, SUV25303152TA, SUV25112813TA, SUV25112814TA, SUV25112815TA, SUV25112816TA, SUV25112817TA, SUV25112818TA, SUV25112819TA, SUV25112820TA, SUV25112821TA, SUV25202956TA, SUV23490712SA, SUV25343216TA, SUV24050933SA, SUV24050934SA, SUV25393383TA, SUV25253087TA, SUV25353262TA, SUV25353263TA, SUV25353264TA, SUV25353265TA, SUV25513744TA, SUV25513745TA, SUV25513746TA, SUV25513747TA, SUV25513748TA, SUV25513749TA, SUV25513750TA, SUV25513751TA, SUV25513752TA, SUV25513753TA, SUV25513754TA, SUV24101195SA, SUV24101196SA, SUV24101197SA, SUV24101198SA, SUV24101199SA, SUV24101200SA, SUV24101201SA, SUV24101202SA, SUV24101203SA, SUV26093963TA, SUV26093964TA, SUV23350294SA, SUV23350295SA, SUV24091164SA, SUV24091165SA, SUV24121277SA, SUV24121278SA, SUV25162929TA, SUV25162930TA, SUV25162931TA, SUV25162932TA, SUV25162933TA, SUV25162934TA, SUV25112822TA, SUV25253085TA, SUV25253086TA, SUV24331825SA, SUV24331826SA, SUV24251600SA, SUV24251601SA, SUV25353246TA, SUV25353247TA, SUV25363275TA, SUV25363276TA, SUV23280236SA, SUV24251589SA, SUV25473492TA, SUV24371938SA, SUV25493644TA, SUV25493645TA, SUV25493646TA, SUV25393385TA, SUV25393386TA, SUV25393392TA, SUV25393393TA, SUV25503728TA, SUV25503729TA, SUV26083898TA, SUV23490708SA, SUV24251591SA, SUV24251592SA, SUV24251594SA, SUV24251595SA, SUV25142882TA, SUV25232994TA, SUV25232995TA, SUV25232996TA, SUV25232997TA, SUV25142878TA, SUV25142881TA, SUV25233013TA, SUV25233014TA, SUV25233015TA, SUV25453464TA, SUV25493693TA, SUV25493694TA, SUV25493695TA, SUV24161354SA, SUV24161355SA, SUV24161356SA, SUV24161357SA, SUV24161358SA, SUV25283128TA, SUV24060988SA, SUV24060989SA, SUV25343217TA, SUV25343218TA, SUV25343219TA, SUV23330279SA, SUV23330280SA, SUV23330281SA, SUV23350299SA, SUV23350300SA, SUV23350301SA, SUV23250199SA, SUV23210100SA, SUV23210101SA, SUV23210102SA, SUV23210103SA, SUV23240187SA, SUV25283136TA, SUV25283137TA, SUV24131330SA, SUV24131331SA, SUV24131332SA, SUV24131333SA, SUV25122860TA, SUV25122861TA, SUV25122862TA, SUV25122863TA, SUV25122864TA, SUV23490696SA, SUV23490697SA, SUV23490698SA, SUV23490699SA, SUV23490700SA, SUV23490701SA, SUV23490702SA, SUV23490703SA, SUV24161353SA, SUV24071077SA, SUV24371939SA, SUV24371940SA, SUV25473572TA, SUV25473573TA, SUV25473574TA, SUV25473575TA, SUV23250200SA, SUV23250201SA, SUV23250202SA, SUV23250203SA, SUV23250204SA, SUV23250205SA, SUV23250206SA, SUV23250207SA, SUV23250208SA, SUV23240155SA, SUV23240156SA, SUV23240157SA, SUV23240158SA, SUV23240159SA, SUV23240160SA, SUV23240161SA, SUV23240162SA, SUV23240151SA, SUV23440441SA, SUV25353244TA, SUV25353245TA, SUV25383366TA, SUV24091148SA, SUV24091149SA, SUV24091150SA, SUV24091151SA, SUV24091152SA, SUV24091153SA, SUV24091154SA, SUV24091155SA, SUV24091156SA, SUV24091157SA, SUV24091158SA, SUV24091159SA, SUV25343213TA, SUV24100791SA, SUV24100792SA, SUV24100793SA, SUV24100794SA, SUV24100795SA, SUV2… (truncated, 32880 characters total — see the official FDA record for the full value)
Recalling firm:
GE Medical Systems Information Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

ALL 50 STATES
Full report

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

Recall #:
98938
Lot/product code:
No UDI, Serial Number or Sales Order Number: KSA7536146, KSA7536158, KSA7536159, KSA7550156, KSA7550158, KSA7550159, KSA7667317, KSA7754389, KSA7769597, KSA7769610, KSA7769612, KSA7773420, KSA7773431, KSA7773440, KSA7120704, KSA7120767, KSA6964886, KSA6808842, KSA6808852, KSA6808866, KSA6808868, KSA6808881, KSA6808883, KSA6808912, KSA6808928, KSA6866974, KSA6664007, KSA6866963, KSA7120766, KSA7162586, KSA6623197, KSA6623216, KSA6623223, KSA6623226, KSA6623239, KSA6623248, KSA6623270, KSA6623278, KSA7391460, KSA6477094, KSA6477095, KSA6477135, KSA6477155, KSA6477159, KSA6477206, KSA6954245, KSA6954269, KSA6954276, KSA6954277, KSA6954284, KSA6954291, KSA6477096, KSA6477154, KSA7702196, KSA7702198, KSA7702199, KSA7702208, KSA7702222, KSA6623191, KSA6623194, KSA6623237, KSA6623251, KSA6623267, KSA6626626, KSA6626632, KSA6626639, KSA6626666, KSA6626670, KSA6626716, KSA6536442, KSA6536443, KSA6536454, KSA6536460, KSA6536469, KSA6536484, KSA6536485, KSA6536490, KSA6536496, KSA6536504, KSA6536526, KSA6536528, KSA6536532, KSA7120699, KSA7120728, KSA7120764, KSA7120773, KSA7162570, KSA7162593, KSA7162610, KSA7162622, KSA7162640, KSA6623198, KSA6623202, KSA6623232, KSA6623236, KSA6623275, KSA6623280, KSA6626622, KSA6626625, KSA6626635, KSA6626636, KSA6626648, KSA6626655, KSA6626659, KSA6626661, KSA6536520, KSA6536525, KSA7304431, KSA6866921, KSA6866926, KSA6866927, KSA6866983, KSA6808882, KSA6649195, KSA6649250, KSA7162575, KSA7162588, KSA7162608, KSA7162614, KSA7162656, KSA6899015, KSA6899022, KSA6808879, KSA5646278, KSA6017318, KSA6017321, KSA6017325, KSA6017333, KSA6017336, KSA6017352, KSA6017360, KSA6017361, KSA6017367, KSA6017368, KSA6017370, KSA6017371, KSA6017377, KSA6017378, KSA6017382, KSA6017383, KSA6017384, KSA6017385, KSA6017387, KSA6017388, KSA6017391, KSA6017404, KSA6017405, KSA6017406, KSA6017407, KSA6017409, KSA6017410, KSA6017416, KSA6017417, KSA6017424, KSA6017445, KSA6017450, KSA6017458, KSA6017471, KSA6017504, KSA6899026, KSA7676874, KSA7676878, KSA7676893, KSA7013925, KSA6808863, KSA6808864, KSA7304413, KSA7304437, KSA6945205, KSA6945208, KSA6945219, KSA6945223, KSA6945230, KSA6945236, KSA6945296, KSA6945314, KSA6945321, KSA6945340, KSA6945350, KSA6945353, KSA6945382, KSA6945387, KSA6899004, KSA6664048, KSA6664049, KSA6664054, KSA6664059, KSA6664075, KSA6664037, KSA6664045, KSA6664065, KSA6664069, KSA6623192, KSA6626641, KSA6626649, KSA6626687, KSA6626691, KSA6626701, KSA6626706, KSA6626707, KSA6626715, KSA6626718, KSA7120720, KSA7162574, KSA7162580, KSA7162632, KSA7162655, KSA6419987, KSA6419993, KSA6420030, KSA6420053, KSA6420080, KSA6420081, KSA6420082, KSA6420102, KSA6664002, KSA6664005, KSA6664036, KSA6664052, KSA6664057, KSA6664078, KSA6664090, KSA6664091, KSA6664006, KSA6866903, KSA6866924, KSA6866928, KSA6866933, KSA6866942, KSA6866977, KSA6866981, KSA6866987, KSA6866992, KSA6866996, KSA6899000, KSA6899060, KSA6945146, KSA6945185, KSA6945190, KSA6945191, KSA6945224, KSA6945250, KSA6945278, KSA6945294, KSA6945311, KSA6945391, KSA6945199, KSA6945204, KSA6945226, KSA6945244, KSA6945258, KSA6945302, KSA6945303, KSA6945319, KSA6945355, KSA6945358, KSA6945359, KSA6945384, KSA7013899, KSA7013902, KSA7013903, KSA7013905, KSA7013912, KSA7013914, KSA7013918, KSA7013921, KSA7013932, KSA7013940, KSA7013955, KSA7013956, KSA7013957, KSA7013963, KSA7013964, KSA7013973, KSA7013975, KSA7013986, KSA6569809, KSA6569821, KSA6569833, KSA6569840, KSA6569867, KSA6569890, KSA6569898, KSA6623189, KSA6623195, KSA6626637, KSA6626651, KSA6626690, KSA6626699, KSA6626713, KSA6626719, KSA6898999, KSA6899011, KSA6899013, KSA6899018, KSA6899021, KSA6899028, KSA6899029, KSA6899033, KSA6899034, KSA6899037, KSA6899051, KSA6899054, KSA6899059, KSA6899067, KSA6899070, KSA6899072, KSA6899074, KSA6899078, KSA6899080, KSA6899084, KSA6899085, KSA6899086, KSA6899092, KSA6899093, KSA6899097, KSA6945099, KSA6945100, KSA6945108, KSA6945113, KSA6945130, KSA6945140, KSA6945171, KSA6945175, KSA6945177, KSA6945183, KSA6945187, KSA6945189, KSA6945254, KSA6945262, KSA6945283, KSA6945288, KSA6945298, KSA6945310, KSA6945328, KSA6945331, KSA6945370, KSA6945377, KSA6945213, KSA6649214, KSA6649226, KSA6649261, KSA6649267, KSA6649272, KSA7120679, KSA7120683, KSA7120693, KSA7120725, KSA7120750, KSA7120754, KSA6689288, KSA6689302, KSA6689309, KSA6689313, KSA6689322, KSA6689364, KSA6689373, KSA6689375, KSA6689382, KSA7442815, KSA7676896, KSA7754382, KSA7754398, KSA7754402, KSA7769599, KSA7769600, KSA7769603, KSA7773423, KSA7773430, KSA7773436, KSA7773442, KSA7744947, KSA7744960, KSA7754384, KSA7754387, KSA7754395, KSA7769605, KSA7769607, KSA7769618, KSA7769622, KSA7773422, KSA7773428, KSA7773444, KSA7239656, KSA7239665, KSA7239668, KSA7239676, KSA7239677, KSA7239678, KSA7239683, KSA7239684, KSA7239686, KSA7239688, KSA7239694, KSA7239696, KSA7239697, KSA7239703, KSA7239704, KSA7239707, KSA7239708, KSA7239711, KSA7239712, KSA7239725, KSA7239728, KSA7239729, KSA7239736, KSA7239737, KSA7239741, KSA7239742, KSA7239743, KSA7239748, KSA6808841, KSA6808859… (truncated, 28437 characters total — see the official FDA record for the full value)
Recalling firm:
GE Medical Systems Information Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

ALL 50 STATES
Full report

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

Recall #:
98881
Lot/product code:
Catalog number: AVA 500 MPAT (Part 2 of 2) Affected material numbers: 87629007, 60729458, 86566648; Affected batch numbers: 251702, 252302, 252502, 252602, 252702, 252802, 253304, 253702, 253704, 253804, 254202, 254304, 254704, 254802;
Recalling firm:
Bayer Medical Care, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

ALL 50 STATES
Full report

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

Recall #:
98938
Lot/product code:
UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA.
Recalling firm:
GE Medical Systems Information Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

ALL 50 STATES
Full report

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

Recall #:
98843
Lot/product code:
Lot Number: F12607207D
Recalling firm:
Devicor Medical Products Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 24, 2026

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

The cannulation of the CCS screw is not centered.

ALL 50 STATES
Full report

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

Recall #:
98952
Lot/product code:
UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
Recalling firm:
Medartis AG
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 24, 2026

Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.

Presence of particulate matter: a white thread-like structure in the cartridge

ALL 50 STATES
Full report

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

Recall #:
D-0541-2026
Lot/product code:
Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.
Recalling firm:
Lupin Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

Temperature probe devices lack FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
98859
Lot/product code:
UDI: 10884521828391, 30884521828395/ Lot: 24D1130JZX 25A1086JZX 25E1332JZX 25I1054JZX 24D1133JZX 25A1087JZX 25F0946JZX 25I1055JZX 24E1015JZX 25A1088JZX 25F0947JZX 25I1056JZX 24E1017JZX 25D0379JZX 25F0948JZX 25I1057JZX 24E1018JZX 25D0380JZX 25F0949JZX 25I1058JZX 24L0848JZX 25D0381JZX 25F0950JZX 25I1059JZX 24L0850JZX 25D1271JZX 25F0953JZX 25I1061JZX 25A1069JZX 25D1272JZX 25F0954JZX 25K1129JZX 25A1070JZX 25D1273JZX 25G1163JZX 25K1130JZX 25A1072JZX 25E1263JZX 25H0935JZX 25K1131JZX 25A1075JZX 25E1264JZX 25H0936JZX 25L0542JZX 25A1076JZX 25E1265JZX 25H0938JZX 25L0545JZX 25A1077JZX 25E1326JZX 25H0939JZX 25L0899JZX 25A1082JZX 25E1329JZX 25H0940JZX 25L0901JZX 25A1084JZX 25E1331JZX 25H0942JZX 25L0903JZX 25A1085JZX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

Temperature probe devices lack FDA clearance.

ALL 50 STATES
Full report

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

Recall #:
98859
Lot/product code:
UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624

Due to stain present on the surface of affected foley catheters.

Full report

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

Recall #:
98716
Lot/product code:
Silastic Brand Foley Catheter 30cc Catalog Number / UDI code: 33416 / 00801741019982 10801741019989 Lot Number: NGKX0444 33418 / 00801741019999 10801741019996 Lot Number: NGKW2813 33420 / 00801741020001 10801741020008 Lot Number: NGKQ1015 33422 / 00801741020018 10801741020015 Lot Number: NGKW3707 33424 / 00801741020025 10801741020022 Lot Number: NGKW2669 Silastic Brand Foley Catheter 5cc Catalog Number / UDI code: 33614 / 00801741020056 10801741020053 Lot Numbers: NGKN4037 NGKP1420 NGKQ0040 NGKQ3901 NGKS4937 NGKV3462 NGKW3897 33616 / 00801741020063 10801741020060 Lot Numbers: NGKQ0042 NGKQ3946 NGKR3420 NGKT3281 NGKU1015 NGKV0617 NGKV2275 NGKV2309 NGKW3771 33618 / 00801741020070 10801741020077 Lot Numbers: NGKQ3370 NGKS3753 NGKT3258 NGKT3309 NGKU4129 NGKV1446 NGKV2345 NGKV3478 NGKV5029 33620 / 00801741020087 10801741020084 Lot Numbers: NGKS5060 NGKT3308 NGKV3689 33622 / 00801741020094 10801741020091 Lot Numbers: NGKQ1016 NGKS0244 NGKU0967 NGKV5075 NGKX0441 33624 / 00801741020100 10801741020107 Lot Numbers: NGKQ1722 NGKQ3862 NGKT3259 NGKX0456
Recalling firm:
C.R. Bard Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

ALL 50 STATES
Full report

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

Recall #:
98819
Lot/product code:
Product Number: DDCP UDI-DI code: 10884522004060 The below product numbers and UDI-DI codes that DDCP are: 4DCFN / 10884522006576 4DCFS / 10884522006583 4DFEN / 10884522006606 6DCFN / 10884522006613 6DCFS / 10884522006620 6DFEN / 10884522006644 8DCFN / 10884522006651 8DCFS / 40884522006690 8DFEN / 10884522006675 10DCFN / 20884522006535 10DCFS / 10884522006545 10DFEN / 10884522006569
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 23, 2026

Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.

Failed Impurities/Degradation Specifications:not meeting quality requirements result occurred in Organic Impurities Test

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

Recall #:
D-0520-2026
Lot/product code:
Lot #: GEH25023, Expires: 6/30/2027
Recalling firm:
JB Chemicals and Pharmaceuticals Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E

The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

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Full report

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

Recall #:
98804
Lot/product code:
All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563; IN-28050: 00810180350051
Recalling firm:
Kico Knee Innovation Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

Temperature probe devices lack FDA clearance.

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

Recall #:
98859
Lot/product code:
UDI: 30884521828388/ Lot: 25F0945JZX 25H0949JZX, 25I1065JZX, 25I1066JZX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, 010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique, 010-113-1208/Small 13 Degree 12mm X 8mm, 010-113-1410/Small 13 Degree 14mm X 10mm, 010-113-1612/Small 13 Degree 16mm X 12mm, 010-119-1407/19 Degree 14mm X 7mm, 010-119-1609/Small 19 Degree 16mm X 9mm, 010-119-1811/Small 19 Degree 18mm X 11mm, 010-125-1606/Small 25 Degree 16mm X 6mm, 010-125-1808/Small 25 Degree 18mm X 8mm, 010-207-1007/Medium 7 Degree 10mm X 7mm, 010-207-1007-2/Medium 7 Degree 10mm X 7mm - Oblique, 010-207-1209/Medium 7 Degree 12mm X 9mm, 010-207-1411/Medium 7 Degree 14mm X 11mm, 010-207-1613/Medium 7 Degree 16mm X 13mm, 010-213-1206/Medium 13 Degree 12mm X 6mm, 010-213-1408/Medium 13 Degree 14mm X 8mm, 010-213-1610/Medium 13 Degree 16mm X 10mm, 010-213-1812/Medium 13 Degree 18mm X 12mm, 010-219-1406/Medium 19 Degree 14mm X 6mm, 010-219-1608/Medium 19 Degree 16mm X 8mm, 010-219-1810/Medium 19 Degree 18mm X 10mm, 010-225-1807/Medium 25 Degree 18mm X 7mm, 010-225-2009/Medium 25 Degree 20mm X 9mm, 010-307-1006/Large 7 Degree,10mm X 6mm, 010-307-1006-2/Large 7 Degree 10mm X 6mm - Oblique, 010-307-1208/ Large 7 Degree 12mm X 8mm, 010-307-1410/Large 7 Degree 14mm X 10mm, 010-307-1612/Large 7 Degree 16mm X 12mm, 010-313-1205/Large 13 Degree 12mm X 5mm, 010-313-1407/Large 13 Degree 14mm X 7mm, 010-313-1609/Large 13 Degree 16mm X 9mm, 010-313-1811/Large 13 Degree 18mm X 11mm, 010-313-2013/Large 13 Degree 20mm X 13mm, 010-319-1606/Large 19 Degree 16mm X 6mm, 010-319-1808/ Large 19 Degree 18mm X 8mm, 010-319-2010/ Large 19 Degree 20mm X 10mm, 010-325-2007/Large 25 Degree 20mm X 7mm, 010-325-2209/ Large 25 Degree 22mm X 9mm, Implant Kits containing OneLIF Interbody Cages, Name/Kit Family: Kit-OneLIF-10 mm (716)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (717)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (718)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (719)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (722)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (723)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (724)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (733)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (734)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (737)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (738)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (746)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (751)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (761)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (762)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (787)/Kit-OneLIF-10 mm, Kit-OneLIF- IMPOneLIF Implant Kit (701)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (702)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (703) NL/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (704)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (705)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (706)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (708)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (709)/Kit-OneLIF-IMP - OneLIF Implant Kit,

Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.

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

Recall #:
98835
Lot/product code:
REF/UDI-DI/ Cage Lots: 010-107-1007/G07001010710070/ 103003, 105701, 118001, 129301; 010-107-1007-2/G070010107100720/ 114301, 117509, 128703; 010-107-1209/G07001010712090/ 102714, 105702, 117501; 010-107-1411/G07001010714110/ 103019, 105703; 010-107-1613/G07001010716130/ 103020, 105704, 127701; 010-113-1006/G07001011310060/ 103021, 105705, 118002, 129801; 010-113-1006-2/G070010113100620/ 117510, 127716, 114302; 010-113-1208/G07001011312080/ 103022, 105706, 117502, 126902; 010-113-1410/G07001011314100/ 102715, 105707, 127702; 010-113-1612/G07001011316120/ 103023, 105708, 127703; 010-119-1407/G07001011914070/ 103024, 105709, 125101, 128701; 010-119-1609/G07001011916090/ 102716, 105710, 127001; 010-119-1811/G07001011918110/ 103025, 105711, 127003; 010-125-1606/G07001012516060/ 102717, 117901, 127002; 010-125-1808/G07001012518080/ 103005, 117902, 127704; 010-207-1007/G07001020710070/ 102702, 106201, 118003, 125102; 010-207-1007-2/G070010207100720/ 117511, 124106, 127717, 114303; 010-207-1209/G07001020712090/ 102701, 105401, 124101, 127705, 101201; 010-207-1411/G07001020714110/ 105001, 105402, 101203; 010-207-1613/G07001020716130/ 103007, 105403, 124102, 127706; 010-213-1206/G07001021312060/ 105002, 105404, 121202, 124103, 127707, 101204; 010-213-1408/G07001021314080/ 102704, 105405, 121203, 124104, 127708; 010-213-1610/G07001021316100/ 103008, 105406, 130101; 010-213-1812/G07001021318120/ 103009, 105407, 127709; 010-219-1406/G07001021914060/ 102705, 105408, 117503, 119301, 121201, 124105; 010-219-1608/G07001021916080/ 103010, 105409, 121204, 127710; 010-219-1810/G07001021918100/ 103011, 105410, 127711; 010-225-1807/G07001022518070/ 102706, 113701, 117001, 121205; 010-225-2009/G07001022520090/ 103001, 117903, 127004, 127712; 010-307-1006/G07001030710060/ 102707, 106202, 118004, 129302; 010-307-1006-2/G070010307100620/ 117512, 127718, 114304; 010-307-1208/G07001030712080/ 102709, 105601, 117504; 010-307-1410/G07001030714100/ 102710, 105602, 127713; 010-307-1612/G07001030716120/ 103012, 105603, 117505; 010-313-1205/G07001031312050/ 103013, 105604, 117506, 129303; 010-313-1407/G07001031314070/ 102711, 105605, 117507, 124107, 128702, 130102; 010-313-1609/G07001031316090/ 103014, 105606; 010-313-1811/G07001031318110/ 103015, 105607, 127714; 010-313-2013/G07001031320130/ 103016, 105608, 127715; 010-319-1606/G07001031916060/ 102712, 105609, 114905, 117508; 010-319-1808/G07001031918080/ 103017, 105610, 125103; 010-319-2010/G07001031920100/ 103018, 105611, 125104; 010-325-2007/G07001032520070/ 102713, 105612, 121206; 010-325-2209/G07001032522090/ 105613, 121207, 101206, 101207, 101208
Recalling firm:
Novapproach Spine, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 23, 2026

iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11

Not guaranteed to be germ-free: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

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

Recall #:
D-0500-2026
Lot/product code:
Lot#: 3T36B, Exp. Date October 31, 2026.
Recalling firm:
Thea Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

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

Recall #:
98911
Lot/product code:
UDI-DI 00848782027514; Lot Number FA22CHQ
Recalling firm:
SSC- Surgical Specialties Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

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Full report

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

Recall #:
98911
Lot/product code:
UDI-DI 00848782027514; Lot Number FA22CHQ
Recalling firm:
SSC- Surgical Specialties Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 23, 2026

Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

Not guaranteed to be germ-free: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

ALL 50 STATES
Full report

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

Recall #:
D-0501-2026
Lot/product code:
Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
Recalling firm:
Thea Pharma, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 23, 2026

Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C

The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

ALL 50 STATES
Full report

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

Recall #:
98804
Lot/product code:
All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563;
Recalling firm:
Kico Knee Innovation Company
View official FDA record (opens in a new tab)