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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 12, 2022 DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic No... Class II DeRoyal Industries Inc
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 12, 2022 BD Pyxis MedBank System - Product Label/labeling pending Due to customer complaints related to the MedBank software which may indicate that a different me... Class II CareFusion 303, Inc.
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Inten... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Nu... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 cobas infinity central lab, Material Number 07154003001 A complaint investigation revealed that an incorrect behavior relating to the rejection of orders... Class II Roche Diagnostics Operations, Inc.
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Inte... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item N... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 epoc Host 2 as follows: Product SMN epoc Host 10736387 e... pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class II Siemens Healthcare Diagnostics Inc
Dec 9, 2022 AXIOM Luminos Agile There is potential for the footrest to detach from the patient table during use. Class II Siemens Medical Solutions USA, Inc
Dec 9, 2022 Alinity m System. The Alinity m System is designed to automate the steps... The firm identified the following three potential issues which may have impacted ADUs installed o... Class II Abbott Molecular, Inc.
Dec 9, 2022 AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF There is potential for the footrest to detach from the patient table during use. Class II Siemens Medical Solutions USA, Inc
Dec 9, 2022 Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max There is potential for the footrest to detach from the patient table during use. Device intend... Class II Siemens Medical Solutions USA, Inc
Dec 8, 2022 RadiaLux Lighted Retractor (Pink), REF: 50-101-1 Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of conta... Class II Medtronic Navigation, Inc.
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasa... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotrache... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Detect Covid-19 Test Product/Model Number: 21205 There is an increased chance that the tests from affected lots may give false negative results. H... Class II Detect Headquarters
Dec 8, 2022 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended ... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 7, 2022 Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 FUSION Dual Pump Packs, REF: OPO73 Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... Class II Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Dec 7, 2022 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY,... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Pediatric Craniotome Ref:CRANI-P-G1 Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Re... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder N... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST T... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Veritas Advanced Infusion Packs, REF: VRT-AI Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... Class II Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Syste... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Nu... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Single-Use Packs, REF: OPO80 Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... Class II Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMa... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, 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.