Browse Device Recalls
39,539 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,539 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 39,539 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 16, 2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... | Class II | Accuray Incorporated |
| Jun 16, 2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... | Class II | Accuray Incorporated |
| Jun 9, 2026 | Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console ... | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersec... | Class II | CMR SURGICAL LIMITED |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 8, 2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atelli... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 8, 2026 | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, | A product error defect may cause incorrect bracket placement. | Class II | Klowen Braces |
| Jun 8, 2026 | Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R | Surgical dressing manufactured out of specification (greater thickness). | Class II | ConvaTec, Inc |
| Jun 8, 2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place.... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2026 | OmniTract Surgical Retractor System, which includes 633 of the firm s product... | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra Lif... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Jun 5, 2026 | Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXE... | Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to repla... | Class II | Olympus Corporation of the Americas |
| Jun 5, 2026 | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model... | May contain incorrect connectors and will not attach or misconnect to ENFit connections and is th... | Class II | Medela Inc |
| Jun 5, 2026 | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the fo... | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device c... | Class II | Philips North America Llc |
| Jun 4, 2026 | VITEK 2 AST-N447 TEST KIT Product reference 424620 | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with... | Class II | Biomerieux Inc |
| Jun 4, 2026 | MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Numb... | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. mar... | Class II | BD SWITZERLAND SARL |
| Jun 3, 2026 | GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 | Reduced or no recovery of some strains of Neisseria gonorrhoeae. | Class II | Remel, Inc |
| Jun 1, 2026 | Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. | Class II | Carl Zeiss Meditec AG |
| May 29, 2026 | Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with... | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to v... | Class I | Hamilton Medical AG |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; ... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTH... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEA... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CD... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEA... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL A... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEAR... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC M... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMA... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL... | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. | Class II | Acumed LLC |
| May 27, 2026 | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circ... | Class II | Medtronic MiniMed, Inc. |
| May 27, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction wer... | Class II | Dexcom, Inc. |
| May 27, 2026 | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 50460... | Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorr... | Class II | Inter-Med Llc |
| May 26, 2026 | Philips Avalon Fetal Monitor, FM 30 Part numberM2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... | Class II | Philips North America Llc |
| May 26, 2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... | Class II | Philips North America Llc |
| May 22, 2026 | IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a re... | Class II | Hamilton Medical AG |
| May 22, 2026 | Medtronic Harmony Delivery Catheter System | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased ... | Class I | Medtronic Heart Valves Division |
| May 22, 2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set ... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set ... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 21, 2026 | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Cata... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAI... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Numb... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catal... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lu... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
| May 21, 2026 | CRE Pro Wireguided 18-20mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgica... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 ... | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... | Class II | Bard Access Systems, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.