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 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Jun 4, 2020 | Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - ... | Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne... | Class II | Cardinal Health 200, LLC |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visu... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescript... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by ... | Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | Class II | HF Acquisition Co., LLC |
| Jun 4, 2020 | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S SR MRI, Model Number W3SR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Azure S DR MRI, Model Number W3DR01 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescripti... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various ... | Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | Class II | HF Acquisition Co., LLC |
| Jun 4, 2020 | Patient Connector, Model Number 24967 | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Pr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescript... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Pre... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various prod... | Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | Class II | HF Acquisition Co., LLC |
| Jun 4, 2020 | STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various p... | Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | Class II | HF Acquisition Co., LLC |
| Jun 4, 2020 | Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usa... | Canisters potentially contain an oversized O-ring that cannot be installed into the mating conne... | Class II | Cardinal Health 200, LLC |
| Jun 4, 2020 | CareLink SmartSync Device Manager, Model Number 24970A | There is a rare communication sequence during the first device interrogation with a SmartSync Dev... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit V... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Pr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 3, 2020 | HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam fo... | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... | Class II | Coltene Whaledent Inc |
| Jun 3, 2020 | MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541... | When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA P... | Class II | Roche Molecular Systems, Inc. |
| Jun 3, 2020 | PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3,... | The tubes may have been delivered to some users without labels. Users may not be able to identify... | Class II | LONGHORN VACCINES AND DIAGNOSTIC |
| Jun 3, 2020 | DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturi... | Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when hold... | Class II | Dufner Instrumente GmbH |
| Jun 3, 2020 | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam ... | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... | Class II | Coltene Whaledent Inc |
| Jun 3, 2020 | HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam f... | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... | Class II | Coltene Whaledent Inc |
| Jun 3, 2020 | HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam... | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... | Class II | Coltene Whaledent Inc |
| Jun 3, 2020 | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Len... | Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicati... | Class II | CooperSurgical, Inc. |
| Jun 2, 2020 | Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usag... | Identified products may contain a damaged bushing within the delivery system, which could potenti... | Class II | Cook Inc. |
| Jun 2, 2020 | EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagn... | Thermo switches in the main power supply for the system may be incorrectly installed, resulting i... | Class II | Philips North America, LLC |
| Jun 2, 2020 | Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only | A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a... | Class II | Baxter Healthcare Corporation |
| May 29, 2020 | RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 10... | Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicat... | Class II | TELEFLEX MEDICAL INC |
| May 28, 2020 | Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection ... | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection ... | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 6 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 5 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 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.