Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2018 | Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.0... | Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller ... | Class II | Zimmer GmbH |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 30, 2018 | Porcine Anorganic Bone Mineral 4.0cc | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume an... | Class III | Collagen Matrix Inc |
| Oct 26, 2018 | Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX ... | Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... | Class II | Merit Medical Systems, Inc. |
| Oct 26, 2018 | Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, R... | Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling... | Class II | Merit Medical Systems, Inc. |
| Oct 24, 2018 | NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoM... | The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date... | Class III | Neomed Inc |
| Oct 22, 2018 | Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108 | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | Class II | Zimmer Biomet, Inc. |
| Oct 22, 2018 | Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | Class II | Zimmer Biomet, Inc. |
| Oct 18, 2018 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. T... | Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitiv... | Class II | Beckman Coulter Inc. |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve S... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Ste... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 16, 2018 | (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx.... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL ... | specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 16, 2018 | Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE ... | Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 16, 2018 | Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 16, 2018 | (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig... | The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... | Class II | Argon Medical Devices, Inc |
| Oct 10, 2018 | Comprehensive Mini Stem, Item No. 113631: | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2018 | Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic S... | Class II | Zimmer Biomet, Inc. |
| 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. |
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.