Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 5, 2018 | EVO Excel, Emission Computed Tomographic System, Material Number 10910501 | The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be l... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 2, 2018 | Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are... | Laser engraved label does not match with the item in the package | Class II | Straumann Manufacturing, Inc. |
| Sep 28, 2018 | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar... | The WHD/WHV impactors can rust over time due to an improper manufacturing process. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, R... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The fi... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 28, 2018 | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type:... | It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. ... | Class II | Paragon 28, Inc. |
| Sep 28, 2018 | TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on t... | The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name ... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 26, 2018 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straig... | During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connecto... | Class I | Oscor, Inc. |
| Sep 25, 2018 | DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305... | Incorrect package labeling identifying the device | Class II | DT MedTech, LLC |
| Sep 25, 2018 | DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114... | Incorrect package labeling identifying the device | Class II | DT MedTech, LLC |
| Sep 24, 2018 | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 | The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the follo... | Class II | Invivo Corporation |
| Sep 21, 2018 | BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos... | The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. ... | Class III | Becton Dickinson & Co. |
| Sep 21, 2018 | Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 in... | The products labeling contains inconsistencies. In certain instances, the lidstock, banner card ... | Class II | Arrow International Inc |
| Sep 18, 2018 | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... | Class I | COVIDIEN LLC |
| Sep 17, 2018 | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with... | The power supply unit for the printer used with the device can potentially overheat or cause a fi... | Class II | Leica Microsystems, Inc. |
| Sep 17, 2018 | Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra... | O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and... | Class II | Medtronic Navigation, Inc.-Littleton |
| Sep 12, 2018 | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 ... | The product inside the package does not match the label. The product was labeled as long thread ... | Class II | Synthes (USA) Products LLC |
| Sep 11, 2018 | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, RE... | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D... | Class III | R & D Systems, Inc. |
| Sep 10, 2018 | -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) ... | Firm identified an issue in the manufacturing process which might contribute to elevated rates of... | Class II | BioFire Diagnostics, LLC |
| Sep 7, 2018 | APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas... | The firm identified customer sites where modules which the safety pacemaker label is missing. Inf... | Class II | Abbott Laboratories, Inc |
| Sep 6, 2018 | CryoPatch SG Pulmonary Hemi-Artery, 1 graft | The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product l... | Class II | CryoLife, Inc. |
| Aug 28, 2018 | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14... | Certain HVAD System Controller units may not meet the labeled standard for protection against wat... | Class II | Heartware, Inc. |
| Aug 24, 2018 | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product... | The firm has identified customer sites where there are modules on which the safety pacemaker labe... | Class II | Inpeco S.A. |
| Aug 24, 2018 | TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tra... | Modifications to the specification were not appropriately qualified through the company's design ... | Class II | TriMed Inc. |
| Aug 23, 2018 | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated... | The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These label... | Class II | Tosoh Bioscience Inc |
| Aug 16, 2018 | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. | There is a possibility that the product was packaged in the wrong box. Specifically, the product... | Class III | Collagen Matrix, Inc. |
| Aug 16, 2018 | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec... | Class III | Medtronic Vascular |
| Aug 14, 2018 | APTIO CENTRIFUGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO 9000 REFRIGERATED STORAGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ... | The product may be counterfeit and could have microbial issues. | Class II | Lens.com |
| Aug 14, 2018 | APTIO RACK OUTPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB - REFRIGERATED STORAGE MODULE 15000 | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB - REFRIGERATED STORAGE MODULE 9000 | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO INPUT/OUTPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | STREAMLAB CORE UNIT / LYNX WITH IOM | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO RACK INPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2018 | APTIO 15000 REFRIGERATED STORAGE MODULE | The modules may have been shipped without a warning label for potential risk of interference to p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 10, 2018 | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | Class III | Medtest Holdings, Inc. |
| Aug 8, 2018 | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic ... | The positive control on some tests of the lots did not appropriately react within the specified t... | Class II | Helena Laboratories, Corp. |
| Aug 8, 2018 | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic U... | The positive control on some tests of the lots did not appropriately react within the specified t... | Class II | Helena Laboratories, Corp. |
| Aug 8, 2018 | Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:008... | The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging ... | Class II | Philips North America LLC |
| Aug 8, 2018 | ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mm... | Two units in distribution were found to be mislabeled on the vial cap with the incorrect part num... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Aug 7, 2018 | ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, R... | The incorrect device was packaged in the vial. | Class II | Implant Direct Sybron Manufacturing, LLC |
| Aug 3, 2018 | Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol i... | Expiration date incorrectly listed on the label | Class II | Zimmer Biomet, Inc. |
| Aug 2, 2018 | Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazon... | The product is labeled with an incorrect expiration date. | Class III | Acumedia Manufacturers, Inc. |
| Aug 2, 2018 | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media... | Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and labe... | Class III | Acumedia Manufacturers, Inc. |
| Aug 1, 2018 | Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ... | Potentially counterfeit products in/and counterfeit packaging were imported to the U.S. | Class II | Allied Vision Group Inc |
| Jul 30, 2018 | Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 P... | The item is labeled as an 8.3mm, but it is actually a 12 mm. | Class II | Zimmer Biomet, Inc. |
| Jul 30, 2018 | ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product ... | Products are labeled with an incorrect expiration date | Class II | Arrow International 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.