Browse Device Recalls
2,601 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,601 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 2,601 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 24, 2023 | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-... | Full screen error message may occur on patient monitors with affected hardware version, either du... | Class II | Remote Diagnostic Technologies Ltd. |
| Aug 23, 2023 | MINISCAV (tm) Vacuum Pump | Inadequate documentation of acceptance activity | Class II | R A Medical Services |
| Aug 23, 2023 | LFS Flat screen arm system with surgical lamp for Models Aurora series, Auror... | The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Aug 23, 2023 | Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 | Expired Product distributed | Class II | Stryker Corporation |
| Aug 23, 2023 | LFS Flat screen support arm systems without surgical lamp for models Aurora s... | The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| 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 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 | 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 | therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Roto... | Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_... | Class II | Qiagen GmbH |
| Aug 22, 2023 | Puritan Bennett Cuff Pressure Manager, REF: 180-03 | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes t... | Class II | Covidien |
| Aug 22, 2023 | 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qu... | 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 | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designe... | 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 | Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm | Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implan... | Class II | Covidien 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 | 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 | Apellis Injection Kit 29g Injection Needle -single use intended to inject flu... | 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred charact... | Class II | Apellis Pharmaceuticals, Inc. |
| Aug 22, 2023 | 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualif... | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... | Class II | 3M Company - Health Care Business |
| 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 | 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 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 | 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 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 | 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 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 | 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 | 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. 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 | 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 | 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 | 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 | 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 | 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 16, 2023 | Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) ... | XXX | 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 | 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 | 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 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 | 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 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 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 | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides ... | Class III | Microbiologics Inc |
| 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 | 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 Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854... | This recall has been initiated due to reports that the product code and product name were incorre... | Class I | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pr... | This recall has been initiated due to reports that the product code and product name were incorre... | Class I | ARROW INTERNATIONAL Inc. |
| 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 | 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 |
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.