Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 16, 2020 | BodyGuard Microset, REF: A120-112XSFK | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: ... | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-003XS2YV | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A100-163XE90S | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset with Filter, REF: A100-164XESF | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | Standard BodySet with Needleless Connectors, REF: A120-125XS | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A100-163XSL | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-161XYBS | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-161XPSV | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset with Filter, REF: A120-160XSFE | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | MatrixMIDFACE Screws - Product Usage: The intended use for this device is in ... | One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a bo... | Class II | Synthes Produktions GmbH |
| Jun 16, 2020 | BodyGuard set with Female Luer, REF: A120-003XSN | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: ... | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | CMExpress Microbore Sets, REF: A120-161C | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-160XSFK | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard BodySet, REF: A120-160SAS | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-160X2YB | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset With Female Luer, REF: A120-160XPSN | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-161XPS | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 15, 2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell C... | Convenience kit mislabeled with the incorrect catheter effective length on the device label and t... | Class III | Access Scientific LLC |
| Jun 15, 2020 | Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Cultu... | An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat... | Class II | Luminex Corporation |
| Jun 15, 2020 | Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Cultur... | An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat... | Class II | Luminex Corporation |
| Jun 12, 2020 | Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is ind... | During internal testing execution of the next generation of Integrated Power Console (IPC) protot... | Class II | Medtronic Xomed, Inc. |
| Jun 11, 2020 | PORT-A-CATH¿ II POWER P.A.C. Low Profile" system. | Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System ... | Class II | Smiths Medical ASD Inc. |
| Jun 10, 2020 | ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:0088687... | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... | Class II | Intuitive Surgical, Inc. |
| Jun 10, 2020 | Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 | The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may ... | Class II | Elekta Instrument AB |
| Jun 10, 2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 008... | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal sur... | Class II | NuVasive Inc |
| Jun 10, 2020 | Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:008868741... | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... | Class II | Intuitive Surgical, Inc. |
| Jun 10, 2020 | PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7... | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years | Class II | Ethicon, Inc. |
| Jun 9, 2020 | enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb... | The toric axis marks were misaligned (from the expected position in relation to the haptics) on a... | Class II | Bausch & Lomb Surgical, Inc. |
| Jun 9, 2020 | Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE O... | QC inspection observed that a portion of the lot may have been contaminated with blood. | Class II | EHOB, Inc. |
| Jun 8, 2020 | Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lnte... | Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867... | Class II | Philips North America, LLC |
| Jun 8, 2020 | ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERIC... | The device may power off without notification to the user resulting in a stoppage of negative pre... | Class II | KCI USA, INC. |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Numbe... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPr... | The motor controller may fail, which can potentially lead to an error in functionality of the Bod... | Class II | Hocoma AG |
| Jun 8, 2020 | Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Numb... | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 8, 2020 | 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External P... | 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The incr... | Class II | New Standard Device Inc |
| Jun 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Jun 5, 2020 | Atellica CH Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 5, 2020 | STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intende... | A missing component (hand suction pump) in the emergency medical kits. | Class II | HF Acquisition Co. LLC |
| Jun 5, 2020 | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) com... | Tube material of a smaller diameter was used. | Class II | Richard Wolf GmbH |
| Jun 5, 2020 | ADVIA Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 5, 2020 | GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the Gli... | When video laryngoscopy system users apply, twisting motions while connecting the blade in the HD... | Class I | Verathon, Inc. |
| Jun 5, 2020 | StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437... | There is a potential for specific camera units to be affected by a characterization issue during ... | Class II | Medtronic Navigation, 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.