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 |
|---|---|---|---|---|
| Jan 9, 2020 | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System | The products are being recalled due to reports of breakage broke at the point of a welded joint e... | Class II | TELEFLEX MEDICAL INC |
| Jan 8, 2020 | Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for ... | Class II | Cordis Corporation |
| Jan 8, 2020 | Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a d... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a dev... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a dev... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a... | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic ... | A software bug may lead to one image to be assigned to two different patients, which could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Mod... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2020 | SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is ... | Two software issues (1) Using the override function in case of blocked system movements affecting... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 7, 2020 | Cocoon Convective Warming System, Product Code: CWS4000 (110V). | Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to im... | Class II | Care Essentials Pty., Ltd. |
| Jan 7, 2020 | Cocoon Convective Warming System, Product Code: CWS5000 (110V). | Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to im... | Class II | Care Essentials Pty., Ltd. |
| Jan 7, 2020 | KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... | Class II | Palodex Group Oy |
| Jan 7, 2020 | cobas infinity core, Material No. 7154003001. The device is a calculator/data... | Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Valid... | Class II | Roche Diagnostics Operations, Inc. |
| Jan 7, 2020 | Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Dr... | Sterile drapes packaged in an unsealed pouch. | Class II | Stryker Corporation |
| Jan 7, 2020 | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... | There is potential for the sterile wrap to become loose while in transit and compromise the steri... | Class II | Medline Industries Inc |
| Jan 7, 2020 | Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... | Class II | Palodex Group Oy |
| Jan 7, 2020 | Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for ... | Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. | Class II | Smiths Medical ASD, Inc. |
| Jan 7, 2020 | Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. ... | Sterile drapes packaged in an unsealed pouch. | Class II | Stryker Corporation |
| Jan 7, 2020 | CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG ... | Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster ... | Class I | CME America, LLC |
| Jan 7, 2020 | Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases... | Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have bro... | Class II | Smiths Medical ASD, Inc. |
| Jan 7, 2020 | Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... | Class II | Palodex Group Oy |
| Jan 7, 2020 | Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL I... | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, E... | Class II | Palodex Group Oy |
| Jan 7, 2020 | THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 ... | Potential increase in fracture rate was detected during internal testing, in addition to potentia... | Class II | Zimmer Biomet, Inc. |
| Jan 6, 2020 | GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) | Firm has received reports of leading end catheter component separations. | Class II | W. L. Gore & Associates Inc. |
| Jan 6, 2020 | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diag... | Carestream Health has discovered a potential safety problem that can lead to unintended movement ... | Class II | Carestream Health, Inc. |
| Jan 6, 2020 | ROSA One 3.1 Brain Application | Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... | Class II | MEDTECH SAS |
| Jan 6, 2020 | Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software... | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 6, 2020 | GORE¿ EXCLUDER¿ AAA Endoprosthesis | Firm has received reports of leading end catheter component separations. | Class II | W. L. Gore & Associates Inc. |
| Jan 6, 2020 | Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software... | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 6, 2020 | ROSA Brain 3.0 Application-Brain | Some cross-sectional images from the image acquisitions of the patients head may not be reconstru... | Class II | MEDTECH SAS |
| Jan 3, 2020 | Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, package... | Lot numbers and products inadvertently not included in the scope of the previous recall. Origina... | Class II | Bard Peripheral Vascular Inc |
| Jan 3, 2020 | Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged i... | Lot numbers and products inadvertently not included in the scope of the previous recall. Origina... | Class II | Bard Peripheral Vascular Inc |
| Jan 3, 2020 | Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, pack... | Lot numbers and products inadvertently not included in the scope of the previous recall. Origina... | Class II | Bard Peripheral Vascular Inc |
| Jan 3, 2020 | Pentax Video Colonoscope Model: EC34-i10L | Distributed in the USA without an approved 510K | Class II | Pentax of America Inc |
| Jan 3, 2020 | Pentax Video Colonoscope Model: EC38-i10L | Distributed in the USA without an approved 510K | Class II | Pentax of America Inc |
| Jan 3, 2020 | Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The de... | Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced t... | Class II | Ethicon, Inc. |
| Jan 3, 2020 | Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, D... | When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to... | Class II | Zimmer Surgical Inc |
| Jan 3, 2020 | Vaginal Verification Panel Ref 8208 Lot 8208-11 | Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Poo... | Class II | Microbiologics Inc |
| Jan 3, 2020 | SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product i... | The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in... | Class II | DePuy Orthopaedics, Inc. |
| Jan 3, 2020 | Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged... | Lot numbers and products inadvertently not included in the scope of the previous recall. Origina... | Class II | Bard Peripheral Vascular Inc |
| Jan 3, 2020 | Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:... | ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were s... | Class II | ROi CPS LLC |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, 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.