Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2m... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic S... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypode... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 7, 2016 | Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laprosc... | Potential lack of assurance of sterility | Class II | Banyan Medical, LLC |
| Sep 7, 2016 | Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Lapr... | Potential lack of assurance of sterility | Class II | Banyan Medical, LLC |
| Aug 11, 2016 | DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surg... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 11, 2016 | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom s... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 3, 2016 | BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe i... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available ... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adap... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, T... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 2, 2016 | Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T... | On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C ha... | Class I | Greatbatch Medical |
| Jul 29, 2016 | Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start... | Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) ... | Class II | B. Braun Medical, Inc. |
| Jul 21, 2016 | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that conta... | Sterility seal integrity failures on the Renasys Sterile Transparent Film | Class II | Smith & Nephew, Inc. |
| Jul 19, 2016 | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... | Sterility compromised due to breach in sterile packaging | Class II | Smith & Nephew, Inc. |
| Jun 27, 2016 | CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 27, 2016 | CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
| Jun 17, 2016 | Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The... | Data from internal studies suggests there may be a potential that the secondary package seal inte... | Class II | Integra LifeSciences Corp. |
| Jun 13, 2016 | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure o... | Potential sterility deficiency. | Class II | Biomet Microfixation, LLC |
| Jun 3, 2016 | Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... | Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recomme... | Class II | Stryker Howmedica Osteonics Corp. |
| May 10, 2016 | Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for... | Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal ... | Class II | CarboFix Orthopedics, Ltd. |
| May 10, 2016 | Double Pump RF Patient Cassette; Product Number: 72204055. Intended to pro... | Sterility of device may be compromised due to sterile package breakage. | Class II | Medical Vision Ab |
| Apr 26, 2016 | Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distribute... | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... | Class II | Greatbatch Medical |
| Apr 26, 2016 | Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: ... | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... | Class II | Greatbatch Medical |
| Apr 26, 2016 | Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, N... | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... | Class II | Greatbatch Medical |
| Mar 31, 2016 | Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neuro... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Prod... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Ne... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usag... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Us... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Prod... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgi... | Product packaging defective compromising sterility | Class II | American Surgical 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.