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 |
|---|---|---|---|---|
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal F... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixati... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 55mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal F... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Poly Screw Driver B. Part of MAXIMIS Pedicle Screw Spina... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedic... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixati... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal F... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Sc... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| 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 |
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.