Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 1, 2023 | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sl... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Express Mini 500 Dry Seal Chest Drain, Part Number 16400 | The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry ... | Class II | Atrium Medical Corporation |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA... | Not able to achieve desired pressure and not holding pressure result from two different causes wh... | Class II | Stryker Corporation |
| Mar 1, 2023 | Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURG... | Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... | Class II | Covidien, LP |
| Mar 1, 2023 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PE... | Due to a software issue where the process of patient scanning, the scatter correction may occasio... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Mar 1, 2023 | Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5... | Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "no... | Class II | Stryker Sustainability Solutions |
| Mar 1, 2023 | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 1, 2023 | Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 1, 2023 | Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prost... | XXX | Class II | Coloplast Manufacturing US, LLC |
| Feb 28, 2023 | BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack | APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 28, 2023 | Omnipod 5 Automated Insulin Delivery System | An error message was received when using the Omnipod 5 App on compatible smartphones that prevent... | Class II | Insulet Corporation |
| Feb 28, 2023 | Monaco RTP System. Used to make treatment plans for patients with prescr... | Re-optimization, after adding contours without forced density outside the external structure, may... | Class II | Elekta Inc |
| Feb 28, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 28, 2023 | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | An actuator separated from the pivot mechanism on a lower monitor boom system column and became d... | Class II | Omega Medical Imaging, Inc. |
| Feb 28, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbe... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 28, 2023 | Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 28, 2023 | Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) ... | There is an issue related to the Safety Disk not meeting a performance requirement that may impac... | Class II | Datascope Corp. |
| Feb 28, 2023 | Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK;... | The external diameter of the biopsy instrument is larger than the internal diameter of the coaxia... | Class II | Bard Peripheral Vascular Inc |
| Feb 28, 2023 | EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella D... | Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porou... | Class II | Encore Medical, LP |
| Feb 27, 2023 | RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device fo... | There is the potential for the program software to malfunction which will not allow it to move fo... | Class II | Appliedvr |
| Feb 27, 2023 | CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular he... | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Fem... | Class II | Zimmer, Inc. |
| Feb 27, 2023 | FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended f... | Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could ... | Class II | FUJIFILM Healthcare Americas Corporation |
| Feb 24, 2023 | Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set ... | Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a probl... | Class II | Iradimed Corporation |
| Feb 24, 2023 | Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device us... | Problem maintaining the stable placement of the battery may come loose from the housing and beco... | Class II | Tobii Dynavox Llc |
| Feb 23, 2023 | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 16... | There have been complaints that the clip did not come out of the tube sheath during the procedure. | Class II | Olympus Corporation of the Americas |
| Feb 23, 2023 | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cer... | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955... | Class II | Aesculap Implant Systems LLC |
| Feb 23, 2023 | Tempus Pro Patient Monitor is a portable vital signs monitor intended to be u... | During internal testing, Regulatory Compliance issues were identified regarding the Monitor and P... | Class II | Remote Diagnostic Technologies Ltd. |
| Feb 22, 2023 | Automated Peritoneal Dialysis System. Used for automatic control of dialysis... | The electrical safety testing was not properly performed on the impacted devices and additional t... | Class II | Baxter Healthcare Corporation |
| Feb 21, 2023 | PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825... | Presence of misleading label statements on the product label. | Class II | Entopsis , Inc. |
| Feb 21, 2023 | Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 | Engaging titanium base contains a dimensional condition that allows vertical movement of the tita... | Class II | Preat Corp |
| Feb 21, 2023 | PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 7... | Presence of misleading label statements on the product label. | Class II | Entopsis , Inc. |
| Feb 21, 2023 | PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety o... | Presence of misleading label statements on the product label. | Class II | Entopsis , Inc. |
| Feb 21, 2023 | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), RE... | Incorrect labeling; specifically, the product name, lot number and product code on the carton lab... | Class II | Biosense Webster, Inc. |
| Feb 21, 2023 | PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid ... | Presence of misleading label statements on the product label. | Class II | Entopsis , Inc. |
| Feb 21, 2023 | PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swa... | Presence of misleading label statements on the product label. | Class II | Entopsis , Inc. |
| Feb 21, 2023 | BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP ... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 21, 2023 | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of ... | Class II | Limacorporate S.p.A |
| Feb 21, 2023 | PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025... | Presence of misleading label statements on the product label. | Class II | Entopsis , Inc. |
| Feb 21, 2023 | BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP ... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 21, 2023 | PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, RE... | Presence of misleading label statements on the product label. | Class II | Entopsis , Inc. |
| Feb 21, 2023 | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF... | Incorrect labeling; specifically, the product name, lot number and product code on the carton lab... | Class II | Biosense Webster, Inc. |
| Feb 20, 2023 | SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 | There are technical issues related to signal generation and processing, which can lead to inaccur... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 20, 2023 | Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained ... | A packaging defect may compromise the sterile barrier. | Class II | Mani, Inc. - Kiyohara Facility |
| Feb 20, 2023 | Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-ter... | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolong... | Class II | Moberg Research, Inc. |
| Feb 20, 2023 | 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 | There are technical issues related to signal generation and processing, which can lead to inaccur... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 17, 2023 | Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be... | Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach. | Class II | Arjohuntleigh Magog, Inc. |
| Feb 17, 2023 | Raystation treatment planning system for radiation therapy, Model Numbers 9.0... | It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle wil... | Class II | RAYSEARCH LABORATORIES AB |
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.