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 |
|---|---|---|---|---|
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fi... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixat... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 19, 2017 | Nussloch GmbH ASP6025 Tissue Processor | Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. | Class II | Leica Microsystems, Inc. |
| Jun 16, 2017 | Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalo... | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. | Class II | Keystone Dental Inc |
| Jun 15, 2017 | Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per ca... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes pe... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 6, 2017 | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchang... | Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite At... | Class II | Spectranetics Corporation |
| Jun 5, 2017 | ECHO POR FMRL NC 9X125, model # 192009 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Lateral Troch Plate Full Crimp - 254mm, model # 350837 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | CER BIOLOXD OPTION HD 32MM, model # 650-1056 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | COMP PRIMARY STEM 8MM MINI, model # 113628 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | OSS CEMENTED IM STEM 12X150, model # 150366 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | Lateral Troch Plate Full Crimp - 254mm, model # 350838 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 5, 2017 | RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 | Possibility that the patient label inside the product box was incorrectly labeled. The outer box... | Class II | Zimmer Biomet, Inc. |
| Jun 2, 2017 | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 | Label on product box contains the incorrect reference #317-09 while the shelf box label with barc... | Class III | C.R. Bard, Inc. |
| Jun 1, 2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above... | Label on the affected devices incorrectly identifies the injection location as "above" the ball... | Class II | Boston Scientific Corporation |
| Jun 1, 2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below... | Label on the affected devices incorrectly identifies the injection location as "above" the ball... | Class II | Boston Scientific Corporation |
| May 31, 2017 | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec... | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pac... | Class III | PerkinElmer Health Sciences, Inc. |
| May 25, 2017 | Logic Fit Tibial Tamp Head | The firm determined that the labeling (surgical technique) should be updated to clarify the prope... | Class II | Exactech, Inc. |
| May 25, 2017 | BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalo... | Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7m... | Class II | Becton Dickinson & Company |
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.