FDA · USDA · CPSC · NHTSA · updated twice a day

Medical device recalls

8 recalls published in the last 7 days. Food, medicines, medical devices, meat and poultry, consumer products and vehicles – 547 recalls since Aug 17, 2026, each with the lot codes, dates and model numbers exactly as the agency lists them.

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Latest recalls

DateRecallProblemAgency
Sep 30, 2026Fresenius Medical Care Renal Therapies Group recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsMedical devices · 1743026 unitsCommunication to recommend reviewing the IFU and ensuring that all treatment preparation a…
Serious
FDA
Class II
Sep 30, 2026Abiomed recall: Automated Impella ControllerMedical devices · 3,322 unitsRetrospective report of issues remedied in 2019 with firmware and software patches: 1. Def…
Serious
FDA
Class II
Sep 30, 2026Philips recall: Achieva 1.5T and 11 more productsMedical devices · 387; 210; 15; 91; 2038; 922; 1447; 596; 82; 611; 37; 965A software issue will terminate an examination during the image reconstruction process if …
Serious
FDA
Class II
Sep 30, 2026Midmark recall: IQvitals ZoneMedical devices · 1 units; 153 units; 20 units; 33 unitsA performance issue may result in inaccurate blood pressure readings when the Linear Defla…
Serious
FDA
Class II
Sep 30, 2026Medline Industries recall: Medline convenience kits containing Healthmark Instrument Channel BrushesMedical devices · 90 kits (US)Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacture…
Serious
FDA
Class II
Sep 30, 2026Olympus Corporation of the Americas recall: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector and 3 more productsMedical devices · 404 units; 105 units; 2,142 units; 816 unitsPotential for detachment of ceramic tip due to manufacturing without the designated amount…
Serious
FDA
Class II
Sep 23, 2026BD Switzerland Sarl recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump…Medical devices · 94,230,757Due to discrepancies in specific attributes in the performance data for infusion sets, whi…
Most serious
FDA
Class I
Sep 23, 2026AVID Medical recall: Halyard IV START KIT NON-STERILE REF: KRIV26-02Medical devices · 288 unitsConvenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators whi…
Most serious
FDA
Class I
Sep 23, 2026Bard Access Systems recall: Power-Trialysis Short-Term Straight Dialysis Catheter and 1 more productMedical devices · 149521; 22,980this is a downstream recall of class I recall RES 98777
Most serious
FDA
Class I
Sep 23, 2026Abiomed recall: Automated Impella Controller and 2 more productsMedical devices · 5232 units (3733 US, 1499 OUS) 36 3; 1422 units (487 US, 935 OUS); 4100 units (2785 US, 1315 OUS) 11 10The potential for purge cassette recognition issues due to the failure of the purge flag c…
Most serious
FDA
Class I
Sep 23, 2026Nova Biomedical recall: StatStrip Glucose Hospital Meter System and 1 more productMedical devices · 20,616 units; 10,941 units; 1,858 units; 8,939 units; 2,044 unitsA software synchronization/timing issue in the barcode scanning and patient data processin…
Most serious
FDA
Class I
Sep 23, 2026Medline Industries recall: Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET and 6 more productsMedical devices · 12 kits; 489 kits; 447 kits; 10407 kits; 2718 kits; 1100 kits; 47848 kitsThe kits contain certain lots of sterile applicators which may contain fungal contaminatio…
Most serious
FDA
Class I
Sep 23, 2026AVID Medical recall: Haylard and 3 more productsMedical devices · 1640 kits; 80 kits; 240 kits; 340 kitsa sterility problem
Most serious
FDA
Class I
Sep 23, 2026Medical Action Industries, Inc. 306 recall: Blood Culture Collection Venipuncture Kit 20/CsMedical devices · 6,420Blood culture convenience kits contain a component subject to a drug recall that due to an…
Serious
FDA
Class II
Sep 23, 2026Nuclein recall: DASH Rapid PCR InstrumentMedical devices · 182Due to a software issue
Serious
FDA
Class II
Sep 23, 2026ICU Medical recall: CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes…Medical devices · 185,688 unitsReservoirs may exhibit medication leakage at the joint between luer connector and tubing. …
Serious
FDA
Class II
Sep 23, 2026restor3d recall: Kinos Axiom Total Ankle System with Axiom PSRMedical devices · 2Ankle implantation systems were packaged with incorrect patient-specific cutting guides, w…
Serious
FDA
Class II
Sep 23, 2026Well Lead Medical recall: SunMed Tracheal TubeMedical devices · 27200The 6Fr suction catheter could not pass through the samples smoothly.
Serious
FDA
Class II
Sep 23, 2026Straumann recall: GM Helix ImplantMedical devices · 216There is a discrepancy between the product identification on the packaging and the dimensi…
Serious
FDA
Class II
Sep 23, 2026embecta Medical II recall: EWO_02512 and 1 more productMedical devices · 4300 Final Count (in EA); 3000 Final Count (in EA)Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvert…
Serious
FDA
Class II
Sep 23, 2026PTW Freiburg recall: RT MonteCarlo 3D v3Medical devices · 2When a bolus is included in a treatment plan and sent for secondary dose calculation, the …
Serious
FDA
Class II
Sep 23, 2026Noxbox recall: NOxBOXi Nitric Oxide Delivery System.Medical devices · 1,547 unitsPotential for oxygen tubing leaks due to failure of the tubing or tubing connection, which…
Serious
FDA
Class II
Sep 23, 2026Medline Industries recall: Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A and 3 more productsMedical devices · 341; 459; 60; 336a sterility problem
Serious
FDA
Class II
Sep 23, 2026Boston Scientific recall: Corporation StoneSmart Connect Console Contents:Medical devices · 982 unitsA subset of power adapters used with the connect console may exhibit higher-than-expected …
Serious
FDA
Class II
Sep 23, 2026Maquet Cardiopulmonary recall: Percutaneous Insertion KitMedical devices · 68371 units (1765 US, 66606 OUS); 185617 units (5926 US, 179691 OUS); 16697 units (492 USA, 16205 OUS)The packaging may not consistently maintain sterile barrier integrity.
Serious
FDA
Class II
Sep 23, 2026Wilson-Cook Medical recall: Hemospray Endoscopic HemostatMedical devices · 121,241 units (U.S.-49240, O.U.S.-72001)Due to issue with endoscope adherence and inability to spray powder. Firm will provide an …
Serious
FDA
Class II
Sep 23, 2026Bayer Medical Care recall: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection SystemMedical devices · 27800 kits (556 boxes)Some devices may not have been properly sterilized due to a manufacturing sterilization is…
Serious
FDA
Class II
Sep 23, 2026Pi Cardia recall: Pi-Cardia IncMedical devices · 46 unitsTransfemoral catheter, positing arm may detached due to weld issue.
Serious
FDA
Class II
Sep 23, 2026Mirion Technologies recall: Captus 4000e Thyroid Uptake SystemMedical devices · 783a fall hazard
Serious
FDA
Class II
Sep 23, 2026F & A Foundation recall: Reign Medical Clench Staple SystemMedical devices · 600Bone fixation staple requires a new 510(k); the performance characteristics of this device…
Serious
FDA
Class II
Sep 23, 2026Howmedica Osteonics recall: AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No and 11 more productsMedical devices · 12,156 USAffected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) …
Serious
FDA
Class II
Sep 23, 2026Philips recall: Patient Information Center iX REF:866389 and 1 more productMedical devices · 7359 Units; 312 unitsDue to software malfunction, patient information system may freeze and become unresponsive…
Serious
FDA
Class II
Sep 23, 2026GE Healthcare recall: Centricity Enterprise Archive V2 and 5 more productsMedical devices · 1856 systems; 1298 systems; 1443 systems; 116 systems; 169 systems; 250 systemsUnder certain conditions historical imaging data migrated from a legacy system may become …
Serious
FDA
Class II
Sep 23, 2026Happiest Baby recall: Inc SNOO Sleep Sack and 1 more productMedical devices · 1055 units; 14837Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety…
Serious
FDA
Class II
Sep 23, 2026Medline Industries recall: Medline Convenience Kit: OPEN HEART A PACKMedical devices · 135 unitsa sterility problem
Serious
FDA
Class II
Sep 23, 2026ICU Medical recall: Plum administration sets and 3 more productsMedical devices · 163,500,199; 2,450; 107,800; 28,550; 100,712,657; 6,105,468; 86,113; 56,553,672Intravascular administration tubing set drip chambers may have black specks potentially du…
Serious
FDA
Class II
Sep 23, 2026GE Medical Systems Information Technologies recall: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04Medical devices · 29,570 (23,632 US; 5,938 OUS)Device may not resume patient monitoring for at least 3 minutes following system restart. …
Serious
FDA
Class II
Sep 23, 2026Datex-Ohmeda recall: Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 and 3 more productsMedical devices · 475 units; 140 units; 7 units; 410 unitsAnesthesia Delivery Systems containing certain electronic gas mixer assemblies can automat…
Serious
FDA
Class II
Sep 23, 2026Stryker Sustainability Solutions recall: REF:2B5LT Ethicon Endo-Surgery and 5 more productsMedical devices · 7,5966 units; 2838 units; 25746 units; 2682 units; 205,704 units; 9072 UNITSReusable access port system may crack or seperate during use.
Serious
FDA
Class II
Sep 16, 2026Given Imaging recall: Bravo CF capsule delivery deviceMedical devices · 127,416a laceration hazard
Most serious
FDA
Class I
Sep 16, 2026Medical Action Industries, Inc. 306 recall: Kit: Epidural/Pain TQC 20/Cs and 1 more productMedical devices · 1,960; 3,606a sterility problem
Most serious
FDA
Class I
Sep 16, 2026AVID Medical recall: Halyard IV Start Kit Non-Sterile REF: KRIV26-02Medical devices · 98 Kitsa sterility problem
Serious
FDA
Class II
Sep 16, 2026Windstone Medical Packaging recall: AMS Convenience Kit: DSAEK PackMedical devices · 3,260 kitsThe convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose …
Serious
FDA
Class II
Sep 16, 2026HeartSine Technologies recall: HeartSine SAM 350P 350P US DeviceMedical devices · 11,912Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Serious
FDA
Class II
Sep 16, 2026Atrium Medical recall: Getinge PVC Thoracic CatheterMedical devices · 3618; 2533; 256An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lo…
Serious
FDA
Class II
Sep 16, 2026C.R. Bard recall: Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914… and 5 more productsMedical devices · 12,463 trays/kits; 283883 trays/kits; 212580; 391720 units/kits; 33850 units/kits; 364Due to complaints received indicating presence of contamination on the surface of pericare…
Serious
FDA
Class II
Sep 16, 2026Lutronic recall: DermaV Laser SystemMedical devices · 1065a fire hazard
Serious
FDA
Class II
Sep 16, 2026Nipro Renal Soultions recall: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 and 3 more productsMedical devices · 3,286 cases; 2,327 cases; 7,770 cases; 100 drums/1072 casesHemodialysis concentrates contain high endotoxin levels
Serious
FDA
Class II
Sep 9, 2026B Braun Medical recall: Discofix Four Way StopcockMedical devices · 25850Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date print…
Serious
FDA
Class II
Sep 9, 2026Baxter Healthcare recall: Baxter Novum IQ Syringe PumpMedical devices · 14601 units; 4 unitsA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a s…
Serious
FDA
Class II
3 or more recalls

Recalls by brand

How to read a recall

Identifiers decide whether your product is included. A recall almost never covers every package with a brand name: it lists lot codes, UPC barcodes, best-by or use-by dates, establishment numbers (the “EST.” number inside the USDA mark on meat and poultry), model numbers or – for vehicles – model years and build dates. Compare them with what you have before you throw anything away.

Which agency: the FDA covers most food, medicines, supplements, cosmetics and medical devices; USDA's Food Safety and Inspection Service covers meat, poultry and processed egg products; the CPSC covers consumer products from toys to appliances; NHTSA covers vehicles, tires, child car seats and motor-vehicle equipment. FDA enforcement reports appear weekly and can list a recall several weeks after the company first announced it.

FAQ

Recall questions

What products were recalled this week?

8 recalls were published by the FDA, USDA, CPSC and NHTSA in the last 7 days, 0 of them in the most serious category: 6 consumer products, 2 vehicles. The newest: Fresenius Medical Care Renal Therapies Group recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (Sep 30, 2026).

How do I know if a product I bought is recalled?

Search this page by brand or product name, then compare the lot code, UPC, best-by date or model number on your package with the identifiers on the recall page – a recall usually covers only certain lots or dates, not every product with that name. For a car, enter your 17-character VIN at nhtsa.gov/recalls.

What does Class I recall mean?

The FDA and USDA rate recalls by risk. Class I is the most serious: a reasonable probability that the product will cause serious health problems or death. Class II may cause temporary or reversible health problems; Class III is unlikely to cause harm.

Do I get my money back for a recalled product?

Usually yes. Food recalls ask you to throw the product away or return it to the store for a refund; CPSC recalls offer a free refund, repair or replacement; vehicle safety recalls are repaired free at a dealer. Each recall page shows the remedy the agency lists.

More

Recalls by type

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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