Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage | This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ... | The sterile battery may contain particulates within the sterile package. | Class II | Pro-Dex Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection | This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System ... | Potential safety latch mechanism failure. The safety latch, within the column that supports the ... | Class II | GE Medical Systems, LLC |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-00... | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or clo... | Class II | Xeridiem Mediem Medical Devices Inc |
| Dec 22, 2015 | CA500 Epix Universal Clip Applier Product Usage: The Epix disposable lap... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 22, 2015 | EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS O... | The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the... | Class II | Bio-Rad Laboratories, Inc. |
| Dec 22, 2015 | Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System | Manufacturing of the joint between the inner catheter and stylet of the delivery system does not ... | Class II | Cook Medical Incorporated |
| Dec 22, 2015 | STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparo... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 22, 2015 | Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus V... | Drager became aware of situations where the error message "Poti unplugged" was generated causing ... | Class I | Draeger Medical, Inc. |
| Dec 22, 2015 | Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: ... | Drager became aware of situations where the error message "Poti unplugged" was generated causing ... | Class I | Draeger Medical, Inc. |
| Dec 22, 2015 | STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable la... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 22, 2015 | The Symbiq infusion pump is a device used in a health care facility to pump f... | Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. | Class II | Hospira Inc. |
| Dec 22, 2015 | InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5... | Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was r... | Class II | Ultradent Products, Inc. |
| Dec 22, 2015 | STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable lap... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 22, 2015 | Syngo Plaza Picture archiving and communication system. Software only. PACS... | Siemens is releasing an updated software version to address several software issues including RGB... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2015 | The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CL... | The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing ... | Class II | Therakos Inc |
| Dec 21, 2015 | The Concerto Basic Shower Trolley is intended for assisted hygiene care, espe... | Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting m... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Dec 21, 2015 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Dens... | A possible malfunction where a Short-term Battery Error message has appeared and has been traced ... | Class II | Fukuda Denshi USA, Inc. |
| Dec 21, 2015 | Hip Preservation System Signature Series PreBent Burs under the following lab... | Metal shavings released from burs during use are due to contact between the bur and the hood of t... | Class II | ConMed Corporation |
| Dec 21, 2015 | NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8... | Product marketed without a 510 (k) | Class II | Northeast Laboratory Services, Inc. |
| Dec 21, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT20... | Reports related to ingress of air into the manifold. | Class II | Acist Medical Systems |
| Dec 21, 2015 | VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 1... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8... | Product marketed without a 510 (k) | Class II | Northeast Laboratory Services, 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.