Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replace... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | The Alinity ci-series System Control Modules which are configured with Alinit... | All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... | Class II | Abbott Gmbh & Co. KG |
| May 21, 2019 | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack... | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line | Class II | Dutch Ophthalmic USA, Inc. |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 17, 2019 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARR... | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (... | Class II | Arrow International Inc |
| May 16, 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Class III | Microbiologics Inc |
| May 16, 2019 | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | Incorrect coil length on the label | Class II | Codman & Shurtleff Inc |
| May 9, 2019 | Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald i... | The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner an... | Class II | Abbott Laboratories |
| May 3, 2019 | Leica Cryostats, used to produce frozen sample sections for biological, medic... | The current labelling does not include any specific warning about usage of flammable freezing spr... | Class II | Leica Microsystems, Inc. |
| May 3, 2019 | OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERIL... | The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (... | Class II | XTANT MEDICAL INC |
| Apr 26, 2019 | Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D... | There is an error in the chromomap on the package insert. | Class III | Cytocell Ltd. |
| Apr 25, 2019 | Lidar System for Erosion Flume Application Class 1 Laser Product Product ... | Failure to comply event due to incorrect labeling of a class 1 laser product. | Class II | ASTRA, LLC |
| Apr 24, 2019 | ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 18, 2019 | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestra... | The products are mislabeled. | Class II | K2M, Inc |
| Apr 18, 2019 | Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO,... | A design related issue can contribute to the device exhibiting brittle behavior. This behavior ma... | Class II | Stryker Neurovascular |
| Apr 18, 2019 | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)... | The products are mislabeled. | Class II | K2M, Inc |
| Apr 16, 2019 | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth El... | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon en... | Class II | Ad-Tech Medical Instrument Corporation |
| Apr 11, 2019 | NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage Pure... | Certain lots were mislabeled with incorrect product number. | Class II | NxStage Medical, Inc. |
| Apr 11, 2019 | NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B S... | Certain lots were mislabeled with incorrect product number. | Class II | NxStage Medical, Inc. |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)0019070701651... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 1, 2019 | Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... | Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x1... | Intermittent heat seal failures on the outer pouch of some EZ Derm products. | Class II | Molnlycke Health Care, Inc |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus ... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usa... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product U... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 22, 2019 | ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus ... | Kit label states not made with natural rubber latex,however safety goggles within the kits contai... | Class II | Cardinal Health 200, LLC |
| Mar 21, 2019 | Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" includin... | Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... | Class II | ROi Consolidated Service Center (CSC) |
| Mar 21, 2019 | Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recal... | Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... | Class II | ROi Consolidated Service Center (CSC) |
| Mar 20, 2019 | Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ... | Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes | Class III | GETINGE US SALES LLC |
| Mar 15, 2019 | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabele... | The form received three complaints related to the user obtaining a result that fell below the tar... | Class II | Response Biomedical Corp. |
| Mar 15, 2019 | Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific re... | There is an error in the chromomap included in the labeling for the product. | Class III | Cytocell Ltd. |
| Mar 13, 2019 | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | Procedure kits include devices from the affected lots distributed OUS only: ... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 13, 2019 | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 13, 2019 | Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidi... | Sterilization method used was not consistent with the labeling and the approved sterilization method | Class II | COVIDIEN LLC |
| Mar 12, 2019 | VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UN... | VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... | Class II | Ethicon, Inc. |
| Mar 12, 2019 | Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized i... | Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, th... | Class II | Beaver Visitec |
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.