Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Short When used wi... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 04404... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERIL... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used wit... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This k... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siem... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K201... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, ST... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Sieme... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When u... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/104643... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx ... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STER... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on ... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrill... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 29, 2017 Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a)... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plas... Device was distributed with the etching missing from the product. Class II Zimmer Biomet, Inc.
Jun 29, 2017 ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative dete... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When ... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is inten... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 29, 2017 NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, N... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Shor... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, R... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit incl... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 6272550... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 29, 2017 SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERI... Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged ... Class II Sorin Group USA, Inc.
Jun 28, 2017 GE Inspection Technologies Blade|line Industrial Cabinet X-ray system GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to compl... Class II GE Inspection Technologies, LP
Jun 27, 2017 Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspi... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a)... Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-press... Class II Terumo Cardiovascular Systems Corporation
Jun 27, 2017 TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-press... Class II Terumo Cardiovascular Systems Corporation
Jun 27, 2017 NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH... The sterile drape material may contain a pinhole compromising its integrity resulting in a breach... Class II NOVADAQ TECHNOLOGIES INC.
Jun 27, 2017 Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # ... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STE... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Jun 27, 2017 NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH... The sterile drape material may contain a pinhole compromising its integrity resulting in a breach... Class II NOVADAQ TECHNOLOGIES INC.
Jun 27, 2017 Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Car... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Jun 27, 2017 Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...

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.