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 9, 2026Fresenius Medical Care Renal Therapies Group recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B and 2 more productsMedical devices · 27,216 cs; 2,316 ea; 2,998 cs; 68 ea; 56,036 cs; 1,788 drums; 204 eaComplaints of blue-green discoloration in product
Serious
FDA
Class II
Sep 9, 2026Medos International Sarl recall: Velys Enabling Tech Robotic-Assist Station REF: 451611001Medical devices · 29 stationsSoftware issue within robotic controller which may cause unintended movement of the roboti…
Serious
FDA
Class II
Sep 9, 2026Medline Industries recall: Medline Convenience Kits containing BD ChloraPrep ClearMedical devices · 222,653 totalConvenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that wer…
Serious
FDA
Class II
Sep 9, 2026Philips recall: Brilliance and 3 more productsMedical devices · N/APhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity…
Serious
FDA
Class II
Sep 9, 2026Boston Scientific recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…Medical devices · N/AThere is potential for a delay in AF Burden Alert notification affecting the server softwa…
Serious
FDA
Class II
Sep 9, 2026Johnson & Johnson Surgical Vision recall: HEALON EndoCoat PROMedical devices · 111,478Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical …
Serious
FDA
Class II
Sep 9, 2026Fresenius Medical Care Renal Therapies Group recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 and 3 more productsMedical devices · 120 units; 62,544 units; 18,600; 6,624 unitsHeightened probability of blood leak from the connection between the Arterial Alpha Clip a…
Serious
FDA
Class II
Sep 9, 2026Cardinal Health 200 recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)…Medical devices · 36 units; 846 units; 19 units; 115 units; 2448 units; 60 units; 61 units; 1398 units; 956 units; 175 units; 645 units; 44 unitsThe Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be cont…
Serious
FDA
Class II
Sep 9, 2026Diagnostica Stago recall: STA Staclot Protein SMedical devices · 5220 unitsA positive drift in QC values within the reagent's stated 4-hour onboard stability period …
Serious
FDA
Class II
Sep 9, 2026AVID Medical recall: Halyard medical convenience kits labeled as: 1) ENT and 2 more productsMedical devices · 11763 kits; 16223 kits; 816 kitsa sterility problem
Serious
FDA
Class II
Sep 9, 2026Medline Industries recall: Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT and 15 more productsMedical devices · 104 kits; 4636 kits; 58037 kits; 17,750 kits; 176 kits; 300 kits; 434,595 kits; 1840 kits; 22736 Kits; 3650 kits; 13032 kits; 3752 kits; 352 kits; 2080 kits; 18290 kits; 996692 kitsa sterility problem
Serious
FDA
Class II
Sep 2, 2026Philips Healthcare recall: Philips Incisive CT with software V4.5&V5.0Medical devices · N/APotential of failing to trigger clinical scan during Bolus Tracking.
Serious
FDA
Class II
Sep 2, 2026FUJIFILM Healthcare Americas recall: FUJIFILM Synapse PACS software v7.4.310Medical devices · 6 unitsSoftware issue may cause the ruler measurement to be inaccurate.
Serious
FDA
Class II
Sep 2, 2026Healthmark Industries recall: Healthmark ProChek-II and 1 more productMedical devices · 5090 units; 53 unitsTest manufactured with an expired ingredient which may present as either a false negative …
Serious
FDA
Class II
Sep 2, 2026ConMed recall: Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm…Medical devices · 2 unitsSuture anchor may contain incorrect patient implant card which may result in incorrect dev…
Serious
FDA
Class II
Sep 2, 2026Henry Schein recall: Structur 2 SC Temporary Resin Cartridge Refill 75Gm and 1 more productMedical devices · 121 units; 853 unitsSpecific lots were distributed in the US with incorrect packaging and Instructions for Use…
Serious
FDA
Class II
Sep 2, 2026Midmark recall: IQecg Digital ECG and 1 more productMedical devices · 3624 unitsA communication anomoly may result in incorrect electrocardiogram waveforms of a patient a…
Serious
FDA
Class II
Sep 2, 2026Hollister Ulc recall: Onli 17cm Hydrophilic Urethral Intermittent CatheterMedical devices · 2526120 unitsHollister has identified that select lots of the catheters identified in the above table m…
Serious
FDA
Class II
Sep 2, 2026Medline Industries recall: Medline medical convenience kit labeled as: TRACH TUBE KITMedical devices · 45 kitsComponent labeling discrepancy
Serious
FDA
Class II
Sep 2, 2026GE Medical Systems Information Technologies recall: Portrait Core Services Software V1.1 and 3 more productsMedical devices · 23 units; 4 units; 15 units; 0Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. I…
Serious
FDA
Class II
Sep 2, 2026American Contract Systems recall: American Contract System Convenience Kit and 1 more productMedical devices · 30 units; 12 unitsThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and R…
Serious
FDA
Class II
Sep 2, 2026AVID Medical recall: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK and 1 more productMedical devices · 45 kits; 63 kits; 78 kits; 120 Kits; 130 KITSLabeling Deficiency: The medical kit labeling fails to identify that the statlock componen…
Serious
FDA
Class II
Sep 2, 2026Medline Industries recall: Medline medical convenience kitsMedical devices · 2262 kits; 246 kits; 3468 kits; 974 kitsSpecific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neuros…
Serious
FDA
Class II
Sep 2, 2026Canon Medical System recall: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital…Medical devices · 10 systemsDue to the fixing screws of ceiling movement gear in ceiling suspended arm that are part o…
Serious
FDA
Class II
Sep 2, 2026Merge Healthcare recall: Merge PACS and Merge OrthoPACSMedical devices · 20 unitsSoftware issue may cause measurements to be displayed inaccurately.
Serious
FDA
Class II
Sep 2, 2026Fresenius Medical Care Renal Therapies Group recall: Fresenius Medical CareMedical devices · 1140 systemsFresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regardi…
Serious
FDA
Class II
Sep 2, 2026Olympus Corporation of the Americas recall: Powerseal 5 MMMedical devices · 335 unitsPotential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-c…
Serious
FDA
Class II
Sep 2, 2026Medline Industries recall: Medline Hudson RCI and 2 more productsMedical devices · 20 units; 145525 units; 271406 unitsNeonatal and infant heated wire breathing circuits may experience sporadic failure. The he…
Serious
FDA
Class II
Sep 2, 2026IMRIS Imaging recall: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned… and 1 more productMedical devices · 6 units; 13 unitsThe linear actuator and rotational lock mechanism components may experience a mechanical f…
Serious
FDA
Class II
Sep 2, 2026Medline Industries recall: Medline convenience kits labeled as: 1) FEMORAL PACK and 10 more productsMedical devices · 71 kits; 263 kits; 24 kits; 94 kits; 15 kits; 663 kits; 1349 kits; 106 kits; 169 kits; 419 kits; 241 kitsKits contain a potentially contaminated component which were recalled by the manufacturer
Serious
FDA
Class II
Aug 26, 2026Bard Access Systems recall: BD Needle Kit for Powered Driver 15mm x 15GaMedical devices · 80,200After placement of intraosseous (IO) needle sets, used when intravenous access is difficul…
Most serious
FDA
Class I
Aug 26, 2026Boston Scientific recall: ENROUTE Transcarotid Neuroprotection System and 1 more productMedical devices · 115,458 units; 49,229 unitsPotential for arterial sheath tip separation or partial tip separation during use.
Most serious
FDA
Class I
Aug 26, 2026BMC Medical recall: BMC/REACTHEALTH Luna G3 APAP REF LG 3600Medical devices · 20,160 unitsRetroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Most serious
FDA
Class I
Aug 26, 2026SDI recall: Dentsply Sirona Capsule Mixer Model NoMedical devices · 1,444 unitsPotential for electrical discharge from unit when unplugged.
Serious
FDA
Class II
Aug 26, 2026Maquet Critical Care AB recall: GETINGE Y SENSOR ModuleMedical devices · 9 unitsThe module did not undergo electrical safety tests and functional tests during production.
Serious
FDA
Class II
Aug 26, 2026Arrowhead DE recall: Arrow-LOK ImplantMedical devices · 4,171a sterility problem
Serious
FDA
Class II
Aug 26, 2026Fort Defiance Industries recall: Automated Field Steam Sterilizer REF: P2131Medical devicesThe Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may e…
Serious
FDA
Class II
Aug 26, 2026Beckman Coulter recall: DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1)… and 1 more productMedical devicesa software defect in which the Parameter Package (PP) import logic overwrites all predefin…
Serious
FDA
Class II
Aug 26, 2026Spectral Instruments recall: Lago X and 1 more productMedical devices · 40; 35Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Serious
FDA
Class II
Aug 26, 2026ConvaTec recall: Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703Medical devices · 617850 unitsUrostomy Pouches may leak from cap during use.
Serious
FDA
Class II
Aug 26, 2026Covidien recall: EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307…Medical devices · 327The system's 24-hour usage limit results in catheters incorrectly flagged as expired, maki…
Serious
FDA
Class II
Aug 26, 2026Siemens Healthcare Diagnostics Products recall: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD and 1 more productMedical devices · 24 units; 478 unitsSyphilis Screen assay may contain a negative patient bias resulting in low reactive patien…
Serious
FDA
Class II
Aug 26, 2026Philips recall: Cardiac Workstation 5000 and 1 more productMedical devices · 796 units; 1,810 unitsDevice will intermittently provide inaccurate data related to native heart rate.
Serious
FDA
Class II
Aug 26, 2026Medtronic MiniMed recall: MiniMedMedical devices · 16; 7; 257Loaner insulin pumps may have been cleaned with chemically incompatible products that coul…
Serious
FDA
Class II
Aug 26, 2026Foundation Medicine recall: Hamilton Microlab STAR Liquid HandlerMedical devices · 32 unitsSoftware issue that can cause an increase in spontaneous software closures.
Serious
FDA
Class II
Aug 26, 2026Kico Knee Innovation recall: Arvis Surgical Navigation System Gen 2Medical devices · 78Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative …
Serious
FDA
Class II
Aug 26, 2026Tobii Dynavox recall: TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 and 1 more productMedical devicesUnder certain conditions, the battery mounting tabs may become damaged, allowing the batte…
Serious
FDA
Class II
Aug 26, 2026Paragonix Technologies recall: Paragonix Technologies IncMedical devices · 1445 systemsDue to a firmware defect, the portable organ transfer device datalogger may lose its confi…
Serious
FDA
Class II
Aug 26, 2026restor3d recall: Veritas Standard Glenoid BaseplateMedical devices · 59Due to incorrect machining of peripheral screw hole resulting in potential for improper en…
Serious
FDA
Class II
Aug 26, 2026Gentherm Medical recall: Blanketrol II Model 222S and 2 more productsMedical devices · 182 units; 46 units; 9714 unitsa fire hazard
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: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B and 2 more products (Sep 9, 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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