Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 17, 2017 | various polyethylene implants Sports Med Repicci II Tibial Components P... | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... | Class II | Zimmer Biomet, Inc. |
| Feb 16, 2017 | Cordis S.M.A.R.T. Flex Vascular Stent System | Deployment Difficulty. | Class II | Cordis Corporation |
| Feb 16, 2017 | MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1... | Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 1... | Class II | Crossroads Extremity Systems Llc |
| Feb 16, 2017 | 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, P... | Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F P... | Class I | Merit Medical Systems, Inc. |
| Feb 16, 2017 | Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Numbe... | A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was a... | Class II | Datascope Corporation |
| Feb 15, 2017 | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantit... | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... | Class II | Focus Diagnostics Inc |
| Feb 15, 2017 | Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small... | One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. | Class II | Greatbatch Medical |
| Feb 15, 2017 | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed ... | Firm has received reports of device operators failing to adhere to instructions for use pertainin... | Class II | Baxter Healthcare Corporation |
| Feb 15, 2017 | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Caps... | When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was d... | Class II | IntroMedic Co., Ltd. |
| Feb 15, 2017 | Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting ... | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... | Class II | Focus Diagnostics Inc |
| Feb 14, 2017 | ARTISTE" MV System | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | Mevatron M2/Primus Mid-Energy PRIMUS HI | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | ONCOR" Expression ONCOR" Impression ONCOR" Impression plus | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (an... | Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200)... | Class II | Euro Diagnostica AB |
| Feb 14, 2017 | ONCOR" Avant-garde | Software update | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2017 | Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates... | Digital templates were created with the incorrect files. | Class II | Zimmer Biomet, Inc. |
| Feb 13, 2017 | Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 | This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modul... | Class II | New Era Orthopaedics, LLc |
| Feb 13, 2017 | Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack I... | Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack... | Class II | Beckman Coulter Inc. |
| Feb 13, 2017 | CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN R... | The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may pre... | Class II | Abbott Laboratories |
| Feb 10, 2017 | Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 m... | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to becom... | Class II | Olympus Corporation of the Americas |
| Feb 10, 2017 | UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical in... | The locking lever pin component of the femoral driver may become deformed and break, resulting in... | Class II | United Orthopedic Corporation |
| Feb 10, 2017 | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI... | Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit diff... | Class II | Abbott Vascular |
| Feb 9, 2017 | SynchroMed II implantable drug infusion pump, Model 8637-40, | Medtronic received a complaint that there was an error code displayed on the programmer when the... | Class II | Medtronic Neuromodulation |
| Feb 9, 2017 | RSP Impaction Fixture | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t... | Class II | Encore Medical, Lp |
| Feb 9, 2017 | Proteus 235 | It has been observed during testing that there could be clinically non-negligible amount of dark ... | Class II | Ion Beam Applications S.A. |
| Feb 9, 2017 | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number... | CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . ... | Class II | Cardiovascular Systems Inc |
| Feb 9, 2017 | Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, ... | Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy ... | Class II | Smiths Medical ASD Inc. |
| Feb 9, 2017 | Turon Impaction Fixture | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t... | Class II | Encore Medical, Lp |
| Feb 9, 2017 | Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm ... | Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users... | Class II | Remel Inc |
| Feb 8, 2017 | BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | AIA-PACK TgAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Feb 8, 2017 | SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | AIA-PACK TPOAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Feb 8, 2017 | Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous... | Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting dow... | Class II | Del Mar Reynolds Medical, Ltd. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (pap... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | Raindrop Near Vision Inlay, Model# RD1-1 | ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to ... | Class II | Revision Optics Inc |
| Feb 7, 2017 | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (e... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) RE... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e240... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIF... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF #... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Intr... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, 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.