Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 20, 2018 | BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 3... | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. | Class II | Becton Dickinson & Company |
| Mar 19, 2018 | Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVI... | Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... | Class II | Teleflex Medical Europe Ltd |
| Mar 16, 2018 | Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 3661... | The product label has missing information, such as the lot number and expiration date, as well as... | Class II | Nobel Biocare Usa Llc |
| Mar 15, 2018 | URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... | Class II | Biocare Medical, LLC |
| Mar 14, 2018 | ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platfor... | The cap on the vial might be labeled with the incorrect part number but the main vial label is co... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Mar 14, 2018 | Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Ac... | The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus ident... | Class II | Accelerate Diagnostics Inc |
| Mar 13, 2018 | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... | Class II | LivaNova USA |
| Mar 13, 2018 | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... | Class II | LivaNova USA |
| Mar 13, 2018 | Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F ... | The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, r... | Class II | Medtronic Vascular |
| Mar 12, 2018 | Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TM... | This device was mislabeled and is not the correct component for this patient. | Class II | TMJ Solutions Inc |
| Mar 12, 2018 | Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of ... | The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labe... | Class II | Stryker GmbH |
| Mar 9, 2018 | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.... | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the... | Class II | The Binding Site Group, Ltd. |
| Mar 8, 2018 | SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) i... | The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. | Class II | Southern Implants, (Pty.) Ltd. |
| Mar 7, 2018 | Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resteri... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Vascular Solutions Venture Rx Catheter, 6F, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic B... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40C... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Bili... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. ... | Products labeled for distribution outside the United States may have been distributed to customer... | Class II | Ethicon, Inc. |
| Mar 5, 2018 | ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medic... | The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 1, 2018 | Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... | Class II | Zimmer Biomet, Inc. |
| Mar 1, 2018 | Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... | Class II | Zimmer Biomet, Inc. |
| Feb 28, 2018 | Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01)... | A potential commingle that could result in the product in the package not matching the product o... | Class II | Zimmer GmbH |
| Feb 28, 2018 | Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)... | A potential commingle that could result in the product in the package not matching the product o... | Class II | Zimmer GmbH |
| Feb 27, 2018 | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) ... | Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of thei... | Class II | Integrity Implants Inc. |
| Feb 26, 2018 | Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catal... | Bags of solution may have a small leak at the base of the injection port where the port is welded... | Class II | Preservation Solutions, Inc. |
| Feb 26, 2018 | Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Numbe... | Products were packaged with incorrect labeling, | Class II | Beaver-Visitec International Inc. |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, da... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 15, 2018 | Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lac... | Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular device... | Class II | Teleflex Medical |
| Feb 8, 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The... | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outl... | Class II | Stanbio Laboratory, LP |
| Feb 7, 2018 | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter Syste... | RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will resu... | Class II | Advanced Instruments, LLC |
| Feb 7, 2018 | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. End... | Device may display a battery missing error. | Class II | Medela Inc |
| Feb 7, 2018 | Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to ... | Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ... | Class II | Halyard Health, Inc |
| Feb 6, 2018 | Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product... | Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with ... | Class II | Baxter Healthcare Corporation |
| Feb 5, 2018 | 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer,... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouche... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, 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.