Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COAT... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)1803... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COA... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | Touchscreen display kit. Sold under the following product names: TOUCHSCREE... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127M... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPL... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT S... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COAT... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280M... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | Aisys Anesthesia System. Sold under the following product names: AISYS, AIS... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 26, 2018 | PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: ... | The products have the potential to leak between the connection of the male luer lock and the yell... | Class II | Becton Dickinson & Company |
| Sep 26, 2018 | Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specim... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straig... | During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connecto... | Class I | Oscor, Inc. |
| Sep 26, 2018 | PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usag... | The products have the potential to leak between the connection of the male luer lock and the yell... | Class II | Becton Dickinson & Company |
| Sep 26, 2018 | Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens ... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indic... | A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-l... | Class II | Accuray Incorporated |
| Sep 26, 2018 | Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens.... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens ... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cra... | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View usin... | Class I | Medtronic Navigation, Inc. |
| Sep 25, 2018 | Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Panda Wall Mount warmer. Infant radiant warmer | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Panda iRes Infant Radiant Warmer. Device sold under the following product nam... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Giraffe Warmer. Device sold under the following product names: Giraffe Warmer... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the follow... | Potential electric leakage affecting the user. | Class II | GE Healthcare, LLC |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
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.