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 |
|---|---|---|---|---|
| Dec 16, 2019 | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. ... | The product contains a different plate than indicated by the package labeling. The product is lab... | Class II | Nextremity Solutions |
| Dec 12, 2019 | Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane ove... | The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instea... | Class II | Arrow International Inc |
| Dec 11, 2019 | Model 250D Ambulatory Blood Pressure Monitor labeled under the following bran... | The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalle... | Class II | Suntech Medical, Inc. |
| Dec 11, 2019 | Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 m... | 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Dia... | Class II | Brasseler USA I Lp |
| Dec 3, 2019 | Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, RE... | Labels with incorrect translations were identified by Exactech is a distributor in the Netherland... | Class II | Exactech, Inc. |
| Dec 3, 2019 | Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, R... | Labels with incorrect translations were identified by Exactech is a distributor in the Netherland... | Class II | Exactech, Inc. |
| Dec 2, 2019 | BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial... | Incorrect product labeling. | Class II | Argon Medical Devices, Inc |
| Dec 2, 2019 | Medical convenience trays and kits, labeled as: Medical Action Industries,... | The kits contain a bottle of saline solution which may exceed the USP specified pH requirements o... | Class II | Medical Action Industries, Inc. 306 |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers ... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers ... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Ster... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolizatio... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Emb... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 21, 2019 | The products involved are DeWALT laser distance measurers, model numbers DW01... | The products are labeled as Class II lasers. However, the level of laser radiation emitted by the... | Class II | STANLEY BLACK & DECKER INC. |
| Nov 18, 2019 | Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. T... | The devices were mislabeled with the incorrect product size resulting in 16Fr devices being label... | Class II | W. L. Gore & Associates Inc. |
| Nov 14, 2019 | Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 11, 2019 | Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST | Components 2mm shorter than indicated on the package label | Class II | Nextremity Solutions |
| Nov 11, 2019 | CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF... | A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm... | Class II | Abbott Medical |
| Nov 11, 2019 | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST | Components 2mm shorter than indicated on the package label | Class II | Nextremity Solutions |
| Nov 11, 2019 | Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST | Components 2mm shorter than indicated on the package label | Class II | Nextremity Solutions |
| Nov 4, 2019 | Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple pr... | False positive results due to potential contamination of reagent. | Class II | Immuno-Mycologics, Inc |
| Nov 4, 2019 | Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product... | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the packa... | Class II | Integra Lifesciences Sales Llc |
| Oct 30, 2019 | HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usa... | The tracheal and brochial swivel connectors are incorrectly labeled. | Class II | Teleflex Medical |
| Oct 30, 2019 | Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each... | Product shelf life may be shorter than that indicated on the label. | Class II | Young Dental Manufacturing Co, LLC |
| Oct 28, 2019 | Genius 2 Tympanic Thermometer Private Label Item Code: 3069 | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... | Class II | Cardinal Health 200, LLC |
| Oct 25, 2019 | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic ma... | Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... | Class II | Zimmer Biomet, Inc. |
| Oct 25, 2019 | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manua... | Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... | Class II | Zimmer Biomet, Inc. |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
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.