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Recalls affecting U.S. Virgin Islands

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

15,933 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
DYNJ84775A UDI-DI 10195327606527 lot 25LMH070 DYNJ47269D UDI-DI 10195327674786 lot 25LMJ234 DYNJ63276G UDI-DI 10198459458835 lot 26BBC598
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

ALL 50 STATES
Full report

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

Recall #:
98842
Lot/product code:
Catalog Number: 405658. UDI Number: (01)00382904056582(17)261001(10)B01V217D. Lot Number (Expiration Date): B01V217D (2026-10-01).
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
DYNJ904305J UDI-DI 10198459268151 lot 25KBT972 DYNJ69533C UDI-DI 10198459524097 lot 26BBC483
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
UDI-DI 10653160378518 Lot 26CBC731
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
UDI-DI 10198459028274 Lot 25LMI820
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: DAVINCI MAIN DYNJ908031D

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
DYNJ908031D UDI-DI 10198459632297 lot 26AMB067
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 27, 2026

Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.

Not guaranteed to be germ-free: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

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-0525-2026
Lot/product code:
Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.
Recalling firm:
Oasis Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.

ALL 50 STATES
Full report

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

Recall #:
98959
Lot/product code:
UDI:00860009268616 Lot: 25G263
Recalling firm:
Oculus Technologies of Mexico, S.A. de C.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
CDS985505G UDI-DI 10195327412555 Lot 26AMC363 DYNJ68260D UDI-DI 10195327506513 Lot 25KBE168 DYNJ905094B UDI-DI 10193489858174 Lot 25KMB136 CDS820091P UDI-DI 10195327403539 Lots 26BBO404 26CBN891
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
UDI-DI 10198459409431 Lot 25KBB755
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
DYNJRA2119A UDI-DI 10198459194702 lot 25LBB738 DYNJRA1011A UDI-DI 10888277783614 lots 25KBB849 25LBB734
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889C

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
DYNDC3525 UDI-DI 10198459576294 Lot 25KBM985 DT13191A UDI-DI 10653160998914 Lot 26AMA168 CDS982047S UDI-DI 10198459385735 Lot 26AMB202 DYNJ62889C UDI-DI 10198459416453 Lot 26AMA584
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

ALL 50 STATES
Full report

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

Recall #:
98951
Lot/product code:
UDI-DI 10198459293535 Lots 26AME511 26AMG737
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
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)
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)
Class IIILow risk
DrugRecalled April 24, 2026

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

ALL 50 STATES
Full report

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

Recall #:
D-0533-2026
Lot/product code:
Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
Recalling firm:
Lannett Company 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 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

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 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

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

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)
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
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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.

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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
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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.
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