Browse Device Recalls
3,528 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,528 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 3,528 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card... | Battery short-run times and unanticipated stoppage may be due to user not performing battery main... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiova... | If battery maintenance is not performed per instructions, the battery may provide less than the m... | Class I | Datascope Corp. |
| Jun 17, 2019 | Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 14, 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with v... | Device vented gas below the stated pressure. | Class I | TELEFLEX-MORRISVILLE |
| Jun 7, 2019 | Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. | Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes du... | Class I | Centurion Medical Products Corporation |
| Jun 5, 2019 | Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used ... | Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with ... | Class I | Qiagen Sciences LLC |
| May 30, 2019 | Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 100... | Reports of pressure relief manifold venting gas below the standard pressure. | Class I | Galemed Corporation |
| May 30, 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710... | Reports of pressure relief manifold venting gas below the standard pressure. | Class I | Galemed Corporation |
| May 30, 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxyge... | Reports of pressure relief manifold venting gas below the standard pressure. | Class I | Galemed Corporation |
| May 29, 2019 | Quantum Pump Console | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut d... | Class I | Spectrum Medical Ltd. |
| May 24, 2019 | Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 24, 2019 | Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 24, 2019 | Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Pro... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 24, 2019 | Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Trachea... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 24, 2019 | Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tub... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 24, 2019 | Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm,... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 24, 2019 | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Ca... | Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... | Class I | Cook Inc. |
| May 24, 2019 | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Cat... | Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... | Class I | Cook Inc. |
| May 24, 2019 | Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b)... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 24, 2019 | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Cat... | Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... | Class I | Cook Inc. |
| May 24, 2019 | Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6... | This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product... | Class I | Teleflex Medical |
| May 14, 2019 | IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.... | Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during c... | Class I | Edwards Lifesciences, LLC |
| May 10, 2019 | Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code ... | This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to... | Class I | Medline Industries Inc |
| May 10, 2019 | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated L... | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonata... | Class I | Teleflex Medical |
| May 6, 2019 | Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294,... | An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment... | Class I | Becton Dickinson & Company |
| May 3, 2019 | Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warm... | The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum leve... | Class I | Medline Industries Inc |
| May 1, 2019 | B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog ... | Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint ... | Class I | B. Braun Medical, Inc. |
| Apr 26, 2019 | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, S... | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... | Class I | Terumo Medical Corporation |
| Apr 26, 2019 | Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSO... | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... | Class I | Terumo Medical Corporation |
| Apr 26, 2019 | SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR... | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... | Class I | Terumo Medical Corporation |
| Apr 11, 2019 | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The E... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 11, 2019 | Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Apr 8, 2019 | MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System ... | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... | Class I | Integra LifeSciences Corp. |
| Apr 8, 2019 | LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS902... | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... | Class I | Integra LifeSciences Corp. |
| Apr 8, 2019 | MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniT... | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... | Class I | Integra LifeSciences Corp. |
| Mar 28, 2019 | Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 28, 2019 | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, ... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 25, 2019 | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTO... | New software version for affected ventilators reduces the probability of the ventilator entering ... | Class I | Hamilton Medical AG |
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.