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Recalls affecting Delaware

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

16,320 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

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

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

Full report

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

Recall #:
98569
Lot/product code:
Lot Code: Part Number: 380746 UDI: 00886874119662 FDA Medical Device Listing Number: D531324 (U.S.) Part Number: 470653-01 Serial Numbers: 1008007 1008008 1008009 1008010 1008011 1008012 1008013 1008015 1008016 1008017 1008020 1008021 1008022 1008024 1008100 1008101 1008102 1008104 1008105 1008107 1008108 1008109 1008112 1008113 1008114 1008115 1008116 1008117 1008997 1008998 1009902 1010029 1010033 1010034 1010036 1010272 1010296 1010297 1010318 1010319 1010449 1010450 1010451 1010496 1010497 1010498 1010499 1010501 1010581 1010618 1010619 1010620 1010621 1010633 1010634 1010635 1010636 1010638 1010640 1010642 1010643 1010644 1010645 1010646 1011333 1011334 1011335 1011336 1011337 1011338 1011340 1011362 1011363 1011364 1011366 1011370 1011371 1011372 1011374 1011377 1011378 1011379 1011380 1011381 1011382 1011383 1011384 1011386 1011388 1011389 1011390 1011391 1011392 1011393 1011394 1011395 1011396 1012056 1012057 1012058 1012059 1012060 1012062 1012063 1012064 1012065 1012066 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10366… (truncated, 11123 characters total — see the official FDA record for the full value)
Recalling firm:
Intuitive Surgical, 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 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 CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, 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: KSA7013962, KSA5646256, KSA5646267, KSA5646268, KSA5646321, KSA5646328, KSA5646242, KSA5646251, KSA5646257, KSA5646284, KSA5646289, KSA5646295, KSA5646297, KSA5646306, KSA5646314, KSA6689326, KSA6689333, KSA6689378, KSA7162600, KSA7162603, KSA7162619, KSA7162631, KSA7769614, KSA6017390, KSA6569811, KSA6569814, KSA6569816, KSA6569853, KSA6569856, KSA6569866, KSA6569875, KSA6569879, KSA6569896, KSA7162612, KSA7162623, KSA7162662, KSA6409156, KSA6409176, KSA6409177, KSA6409181, KSA6420012, KSA6420057, KSA6420088, KSA6420106, KSA7013897, KSA5646292, KSA6409244, KSA7162605, KSA6808884, KSA7304364, KSA7304449, KSA7304452, KSA6590164, KSA7304435, KSA6954216, KSA6954221, KSA6626645, KSA6689380, KSA6808843, KSA6808843, KSA6808873, KSA6808874, KSA6808897, KSA6808897, KSA6623262, KSA6945167, KSA6017455, KSA7096908, KSA7096928, KSA7096932, KSA7096935, KSA7096940, KSA7096941, KSA7096946, KSA7096959, KSA7096971, KSA7096976, KSA7096985, KSA7096986, KSA7096994, KSA7550169, KSA7304426, KSA6017413, KSA6420074, KSA7442867, KSA7520473, KSA6945379, KSA7495811, KSA7495812, KSA7495828, KSA7495833, KSA6623187, KSA6623188, KSA6623208, KSA6623241, KSA6623249, KSA6623265, KSA6623273, KSA6623282, KSA6664042, KSA6017434, KSA6017505, KSA6664062, KSA6664066, KSA7162592, KSA5646252, KSA7304361, KSA7304418, KSA6689310, KSA6689342, KSA7391408, KSA7391483, KSA7442814, KSA7442876, KSA5646246, KSA6017327, KSA6017337, KSA6017411, KSA6017418, KSA6017452, KSA7574793, KSA6899017, KSA6899063, KSA7013916, KSA7013926, KSA7013985, KSA6945142, KSA6945304, KSA7509846, KSA7509848, KSA7520466, KSA7520486, KSA7716910, KSA7716914, KSA7744944, KSA6409155, KSA6420064, KSA6626658, KSA6808891, KSA6808910, KSA7162609, KSA7304373, KSA7304430, KSA7162584, KSA7239702, KSA7304389, KSA7304427, KSA7304450, KSA7550170, KSA7590261, KSA7590265, KSA7590268, KSA7391447, KSA6590189, KSA6626712, KSA5646253, KSA5646280, KSA7495807, KSA7495816, KSA7495829, KSA6017341, KSA6017348, KSA6017362, KSA6017380, KSA6017469, KSA6017481, KSA5646296, KSA5646275, KSA5646276, KSA5646299, KSA5646307, KSA5646322, KSA6945203, KSA7442837, KSA7442886, KSA6590183, KSA7120771, KSA6945201, KSA7590244, KSA7590250, KSA7590255, KSA7667331, KSA5646244, KSA5646285, KSA5646287, KSA5646293, KSA5646301, KSA5646302, KSA5646305, KSA5646320, KSA5646330, KSA6945295, KSA6017345, KSA6017349, KSA6017354, KSA6017427, KSA6017482, KSA6017493, KSA6017500, KSA6017507, KSA6808932, KSA6017359, KSA6477222, KSA7509839, KSA7509841, KSA6964881, KSA6964929, KSA6590131, KSA6590148, KSA6590150, KSA6590165, KSA6590167, KSA6590171, KSA6590180, KSA6590182, KSA6590193, KSA6590196, KSA6590217, KSA6590220, KSA7442861, KSA6899014, KSA7716916, KSA7716917, KSA7716935, KSA6419990, KSA6420003, KSA6017330, KSA7550164, KSA7574776, KSA7239690, KSA7239706, KSA7239713, KSA6536472, KSA6536494, KSA6536534, KSA7676886, KSA7744939, KSA7744956, KSA6409197, KSA6409202, KSA6409203, KSA6409211, KSA6409217, KSA6409230, KSA6409240, KSA6409253, KSA6536445, KSA6536537, KSA7162660, KSA6420022, KSA6808878, KSA7716911, KSA7716912, KSA7716915, KSA7716919, KSA7716921, KSA7716932, KSA6899010, KSA6899041, KSA6899042, KSA6899076, KSA7304363, KSA7304440, KSA7442799, KSA7442817, KSA7442818, KSA7442821, KSA7442827, KSA7442838, KSA7442858, KSA7442870, KSA7442881, KSA7442891, KSA7485738, KSA7485755, KSA7485758, KSA7485761, KSA7485763, KSA7495820, KSA7495824, KSA7495825, KSA6649175, KSA6649203, KSA5646271, KSA5646298, KSA5646325, KSA5646250, KSA7442779, KSA7442784, KSA7442819, KSA7442830, KSA7442850, KSA7442853, KSA7442863, KSA6623220, KSA6623274, KSA7391414, KSA7391430, KSA7391453, KSA7391491, KSA6945297, KSA6945372, KSA6409167, KSA6017315, KSA6017503, KSA6536511, KSA6569838, KSA7716922, KSA7716926, KSA7716931, KSA7716937, KSA7716909, KSA7716930, KSA6623221, KSA6866913, KSA6866940, KSA6866941, KSA6866948, KSA6866964, KSA5646283, KSA5646313, KSA6017351, KSA6017365, KSA6017376, KSA6017463, KSA7509834, KSA6017334, KSA6017343, KSA6017381, KSA6017419, KSA6664060, KSA6017401, KSA6017312, KSA6569891, KSA6017346, KSA6017347, KSA6017369, KSA6017374, KSA6017375, KSA6017399, KSA6017443, KSA6017446, KSA6017448, KSA7536142, KSA7550148, KSA7550157, KSA7550161, KSA7550163, KSA7574770, KSA7574771, KSA7574777, KSA7574782, KSA7574787, KSA7574791, KSA7574792, KSA6017453, KSA5646248, KSA5646259, KSA5646272, KSA5646274, KSA5646291, KSA5646300, KSA5646316, KSA5646319, KSA7391404, KSA7391410, KSA7391418, KSA7391464, KSA7391478, KSA7391480, KSA7391490, KSA7391495, KSA6017400, KSA6017350, KSA6017364, KSA7590248, KSA7590253, KSA7590254, KSA7773445, KSA6689312, KSA6017395, KSA6964950, KSA7013907, KSA7013959, KSA7442804, KSA6866971, KSA6649205, KSA6649268, KSA6623250, KSA6419997, KSA6420001, KSA6420091, KSA6420110, KSA7239654, KSA7239710, KSA6477237, KSA7724019, KSA7724026, KSA7724032, KSA7724035, KSA7724036, KSA7724046, KSA7724047, KSA7727675, KSA7727676, KSA7727688, KSA7732499, KSA7732500, KSA7732512, KSA7732513, KSA7732516, KSA7732525, KSA6964962… (truncated, 15033 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
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

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

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

Full report

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

Recall #:
98569
Lot/product code:
Lot Code: Part Number: 380746 UDI: 00886874119662 FDA Medical Device Listing Number: D531324 (U.S.) Part Number: 470653-01 Serial Numbers: 1008007 1008008 1008009 1008010 1008011 1008012 1008013 1008015 1008016 1008017 1008020 1008021 1008022 1008024 1008100 1008101 1008102 1008104 1008105 1008107 1008108 1008109 1008112 1008113 1008114 1008115 1008116 1008117 1008997 1008998 1009902 1010029 1010033 1010034 1010036 1010272 1010296 1010297 1010318 1010319 1010449 1010450 1010451 1010496 1010497 1010498 1010499 1010501 1010581 1010618 1010619 1010620 1010621 1010633 1010634 1010635 1010636 1010638 1010640 1010642 1010643 1010644 1010645 1010646 1011333 1011334 1011335 1011336 1011337 1011338 1011340 1011362 1011363 1011364 1011366 1011370 1011371 1011372 1011374 1011377 1011378 1011379 1011380 1011381 1011382 1011383 1011384 1011386 1011388 1011389 1011390 1011391 1011392 1011393 1011394 1011395 1011396 1012056 1012057 1012058 1012059 1012060 1012062 1012063 1012064 1012065 1012066 1012068 1012069 1012070 1012071 1012073 1012075 1012076 1012078 1012079 1012080 1012081 1012082 1012084 1012085 1012284 1012998 1012999 1013001 1013002 1013003 1013004 1013005 1013007 1013008 1013009 1013010 1013011 1013012 1013013 1013015 1013017 1013019 1013108 1013109 1013110 1013111 1013112 1013113 1013114 1013115 1013116 1013117 1013118 1013119 1013120 1013121 1013122 1013124 1013125 1013126 1013127 1013129 1013130 1013132 1013491 1013492 1013493 1013494 1013496 1013497 1014027 1014028 1014029 1014030 1014031 1014032 1014034 1014036 1014037 1014038 1014039 1014140 1014143 1014146 1014147 1014149 1014150 1014151 1014152 1014153 1014154 1014155 1014156 1014158 1014159 1014160 1014163 1014164 1014165 1014166 1014167 1014168 1014169 1014170 1014171 1014173 1014174 1014175 1014177 1014178 1014574 1014575 1014576 1014577 1014578 1014580 1014581 1014582 1014583 1014584 1014585 1014586 1014587 1014589 1014590 1014591 1014592 1014594 1014595 1014596 1014597 1014598 1014599 1014600 1014601 1014602 1014603 1014604 1014605 1014606 1014607 1014608 1014609 1014610 1014611 1014612 1014613 1014615 1014616 1014618 1014619 1014622 1014623 1014624 1014721 1014722 1014723 1014724 1014725 1014726 1014727 1014728 1014729 1014730 1014731 1015247 1015248 1015250 1015251 1015252 1015253 1015254 1015255 1015256 1015257 1015258 1015259 1015260 1015261 1015262 1015263 1015264 1015266 1015854 1015855 1016110 1016111 1016112 1016113 1016114 1016115 1016117 1016118 1016119 1016120 1016122 1016123 1016124 1016125 1016126 1016127 1016128 1016129 1016130 1016136 1016137 1016138 1016139 1016140 1016141 1016142 1016143 1016144 1016150 1016151 1016152 1016153 1016154 1016155 1016475 1016478 1016479 1016480 1016481 1016482 1016483 1016484 1016601 1016602 1016603 1016604 1016605 1016606 1016607 1016608 1016791 1017181 1017182 1017327 1017328 1017329 1017330 1017331 1017332 1017333 1017334 1017336 1017337 1017338 1017340 1017341 1017343 1017345 1017346 1017347 1017348 1017545 1017547 1017549 1017550 1017552 1017553 1017555 1017556 1017557 1017558 1017560 1017561 1017562 1017565 1017566 1017569 1017570 1017571 1017572 1017573 1017867 1017871 1017873 1017874 1017875 1017878 1017879 1017880 1017882 1017884 1017887 1017888 1017890 1017891 1017893 1017894 1017895 1017896 1017898 1017899 1017900 1017902 1017903 1017904 1018075 1018076 1018108 1018109 1018110 1018111 1018112 1018114 1018146 1018148 1018150 1018151 1018152 1018153 1018194 1018195 1018196 1018197 1018198 1018199 1018256 1025415 1025416 1025417 1025418 1025419 1025420 1025421 1025427 1025433 1025434 1025435 1025436 1025437 1025438 1025439 1025440 1025442 1025443 1025444 1025716 1025717 1025718 1025719 1025720 1025721 1025722 1025723 1025724 1025725 1025726 1025727 1025728 1025729 1025730 1025731 1025732 1025733 1025734 1026046 1026047 1026048 1026049 1026051 1026052 1026770 1026771 1026772 1026773 1026774 1026775 1026776 1026779 1026780 1026781 1026782 1026783 1026784 1026786 1026787 1026788 1027960 1027961 1027962 1027963 1027964 1027965 1027966 1027967 1028043 1028044 1028045 1028046 1028047 1028048 1028049 1028050 1028051 1028052 1028053 1028054 1028057 1028078 1028080 1030040 1030042 1030043 1030044 1030045 1030046 1030048 1030069 1030090 1030091 1030092 1030093 1030095 1030096 1030098 1030099 1030102 1030103 1030104 1030105 1030106 1030108 1031386 1031387 1031388 1031389 1031390 1031391 1031392 1031393 1031394 1031395 1031396 1031397 1031398 1031399 1031400 1031401 1031402 1031403 1031404 1031406 1033055 1033056 1033057 1033058 1033059 1033060 1033061 1033062 1033063 1033064 1033066 1033067 1033068 1033069 1033070 1033071 1033072 1033073 1033074 1033075 1033076 1033077 1033078 1033079 1033080 1033081 1033083 1033084 1033085 1033086 1033087 1033088 1033089 1033090 1034577 1034578 1034579 1034580 1034581 1034582 1034583 1034585 1034586 1034587 1034588 1034589 1034590 1034593 1034594 1034595 1034596 1036621 1036622 1036625 1036626 1036630 1036631 1036632 1036633 1036634 1036635 1036636 1036637 1036638 10366… (truncated, 11123 characters total — see the official FDA record for the full value)
Recalling firm:
Intuitive Surgical, 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)
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)
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.

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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)
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.

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-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

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)
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.

ALL 50 STATES
Full report

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

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)
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

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

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

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.

ALL 50 STATES
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)
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.

ALL 50 STATES
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)
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.

ALL 50 STATES
Full report

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
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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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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)