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 31, 2015 | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a C... | Incorrect cannula of the sheath introducer (smaller than intended). | Class II | Cordis Corporation |
| Dec 31, 2015 | The e.cam Dual Signature Gamma Camera system. Used to detect or image the di... | To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not ... | Class II | Siemens Medical Solutions USA, Inc. |
| Dec 30, 2015 | This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody ... | The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequat... | Class II | Leica Microsystems, Inc. |
| Dec 29, 2015 | ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit)... | PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 29, 2015 | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and ... | The AQURE System has a design error regarding sample type in which sample type may be specified f... | Class II | Radiometer America Inc |
| Dec 29, 2015 | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Pr... | Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) | Class II | Pharmacaribe llc |
| Dec 28, 2015 | EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is int... | All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may ... | Class II | Phadia Ab |
| Dec 24, 2015 | MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. | The system loaded a completion fraction in the incorrect order after a treatment interruption. | Class II | Viewray Incorporated |
| Dec 24, 2015 | BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bott... | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradati... | Class II | bioMerieux, Inc. |
| Dec 24, 2015 | BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottl... | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradati... | Class II | bioMerieux, Inc. |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548920 (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: M00548750 (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: M00548560 (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: M00549390 (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: M00548850 (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: M00549570 (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: M00548830 (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: M00548650 (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: M00548950 (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: M00548680 (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: MM00548410 (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 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548470 (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: M00549410 (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: M00548620 (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: M00548510 (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: M00549340 (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-450XT5 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: M00548900 (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: M00548340 (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 | Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusi... | Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMD... | Class II | MOOG Medical Devices Group |
| Dec 23, 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00549330 (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: M00548720 (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: M00548800 (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: M00549520 (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: M00549580 (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: M00548330 (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: M00549600 (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: M00548480 (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: M00549310 (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: M00548450 (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: M00548660 (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: M00548440 (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: M00548810 (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: M00548960 (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: M00549480 (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: M00549440 (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: M00548540 (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: M00548600 (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: M00548770 (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 |
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.