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 |
|---|---|---|---|---|
| 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. |
| Feb 5, 2018 | 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotati... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Cla... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 5, 2018 | 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connect... | The infusion sets were manufactured with an incorrect spin collar. | Class II | ICU Medical, Inc. |
| Feb 2, 2018 | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one... | Class II | Shippert Medical Technologies | |
| Feb 2, 2018 | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... | This recall has been identified due to the batch being mislabeled, with the packaged component's... | Class II | Signature Orthopedics Pty Limited |
| Feb 2, 2018 | Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patie... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-p... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Feb 2, 2018 | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one... | Class II | Shippert Medical Technologies | |
| Feb 2, 2018 | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, on... | The pouch integrity of the sterile product can't be assured without a visual examination due to p... | Class II | Shippert Medical Technologies |
| Jan 31, 2018 | FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... | Class II | 3M Company - Health Care Business |
| Jan 31, 2018 | ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... | Class II | 3M Company - Health Care Business |
| Jan 30, 2018 | Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The kn... | Customers may receive the incorrect size implant from what is labeled on the box. | Class II | Howmedica Osteonics Corp. |
| Jan 29, 2018 | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytomet... | The device may process the same sample with two different sample IDs and sample information while... | Class II | Beckman Coulter Inc. |
| Jan 23, 2018 | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0m... | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 22, 2018 | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A ... | DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valv... | Class II | DeRoyal Industries Inc |
| Jan 22, 2018 | Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors... | The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated... | Class II | Valeris Medical, LLC |
| Jan 19, 2018 | InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC | Insulin syringe retail packages incorrectly labeled as "Short Needle". | Class II | Allison 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.