Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 22, 2023 | REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, ... | Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5... | Class II | Encore Medical, LP |
| Aug 22, 2023 | Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P... | The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) b... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2023 | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed... | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... | Class II | 3M Company - Health Care Business |
| Aug 22, 2023 | EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H | Knee insert and acetabular system parts were swapped within inner pack prior to the product being... | Class II | Encore Medical, LP |
| Aug 22, 2023 | EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 | Knee insert and acetabular system parts were swapped within inner pack prior to the product being... | Class II | Encore Medical, LP |
| Aug 18, 2023 | Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC866... | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the pro... | Class II | North Coast Medical Inc |
| Aug 18, 2023 | OPMI LUMERA 300, REF 6137 | Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, whic... | Class II | Carl Zeiss Suzhou Co., Ltd. |
| Aug 18, 2023 | Constellation Vision System, REF: 8065751150 | Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could ... | Class II | Alcon Research, LLC |
| Aug 18, 2023 | BD Pyxis MedBank MedPass Software, REF: 139088-01 | After dispensing a timed dose medication for a patient, the automated dispensing cabinet software... | Class II | CareFusion 303, Inc. |
| Aug 17, 2023 | Patient Information Center iX with Software Version Number 4.x in the followi... | Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driv... | Class II | Philips North America Llc |
| Aug 17, 2023 | exoplan version 3.1 Rijeka Software -A medical software, intended to support ... | A software library filtering error has been discovered which occurs when users are using the Step... | Class II | Exocad GmbH |
| Aug 17, 2023 | SOZO Bilateral Arm L-Dex Software | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect ea... | Class II | Impedimed Limited |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) ... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gal... | Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... | Class II | Abbott Medical |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MH... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDH... | Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... | Class II | Abbott Medical |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexne... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on... | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Steri... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Fr... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced S... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) ... | XXX | Class II | Cardinal Health 200, LLC |
| Aug 16, 2023 | Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 | A force sensor in the occlusion detector may drift out of calibration leading to increased occlus... | Class II | Smiths Medical ASD Inc. |
| Aug 15, 2023 | Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and Mu... | A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiatio... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 14, 2023 | remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B St... | On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during custome... | Class II | Remel, Inc |
| Aug 10, 2023 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, R... | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in ... | Class II | Covidien |
| Aug 10, 2023 | Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SP... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05... | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Su... | Class II | ETHICON, LLC |
| Aug 10, 2023 | Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for ... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 | Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy i... | Class II | Bard Peripheral Vascular Inc |
| Aug 10, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software update corrected an issue where "low" and "terminal" battery alerts did not display on... | Class II | Turncare, Inc |
| Aug 10, 2023 | Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS ... | This recall has been initiated due to reports that the product code and product name were incorre... | Class II | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 2... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP... | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Su... | Class II | ETHICON, LLC |
| Aug 10, 2023 | Functional MR V1.0 | When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting mu... | Class II | OLEA MEDICAL |
| Aug 10, 2023 | Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Univ... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ... | Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2023 | Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Naviga... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, R... | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in ... | Class II | Covidien |
| Aug 10, 2023 | Welch Allyn Connex Spot Monitor | Product is being recalled due to the improper placement of a copper tape on the back of the liqui... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2023 | Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; cathe... | This recall has been initiated due to reports that the product code and product name were incorre... | Class II | ARROW INTERNATIONAL Inc. |
| Aug 9, 2023 | Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry Sy... | Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactur... | Class II | Ortho-Clinical Diagnostics, 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.