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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

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

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.

Clear
DateProductReasonClassFirm
May 30, 2017 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manif... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 30, 2017 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotat... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 30, 2017 LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977... The incorrect Loctite adhesive was used to assemble the impactor heads. Class II Smith & Nephew, Inc.
May 30, 2017 ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle... ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not ... Class II EOS Imaging
May 30, 2017 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... Class II ICU Medical, Inc.
May 25, 2017 Logic Fit Tibial Tamp Head The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-2... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all othe... Carestream found a single unit where four screws in the assembly were not applied in the manufact... Class II Carestream Health Inc
May 25, 2017 EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalo... Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7m... Class II Becton Dickinson & Company
May 25, 2017 EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyuretha... The kit was packaged with the incorrect introducer needle size. The label indicates the kit cont... Class II Medical Components, Inc dba MedComp
May 25, 2017 Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part... Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received ... Class II Atrium Medical Corporation
May 25, 2017 EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmi... Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the micros... Class II Alcon Research, Ltd.
May 25, 2017 EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Cat... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: ... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 24, 2017 Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used wi... The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. Acc... Class II Northgate Technologies, Inc.
May 24, 2017 Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha... Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... Class II Merge Healthcare, Inc.
May 24, 2017 Merge OrthoPACS software. A migrated study that has annotations will display the annotations, but when a prior study is loa... Class II Merge Healthcare, Inc.
May 24, 2017 Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in ... When performing the Stitching function on GU60A system, unintended area is exposed to radiation Class II NeuroLogica Corporation
May 23, 2017 SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-20... Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class II Shimadzu Medical Systems Usa Com
May 23, 2017 Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SM... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product U... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, Inc.
May 23, 2017 Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to... Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and E... Class II Pentax of America Inc
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ra... Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class II Shimadzu Medical Systems Usa Com
May 23, 2017 Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (S... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: ... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended t... Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and E... Class II Pentax of America Inc
May 23, 2017 SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. Class II Shimadzu Medical Systems Usa Com
May 23, 2017 Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic ir... If the gantry module is replaced after original installation the configuration settings may be mi... Class II Elekta, Inc.
May 23, 2017 Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (S... Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [... Class II Siemens Healthcare Diagnostics, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 22, 2017 TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE There is a potential risk of puncture to the packaging material which can compromise the devices ... Class II Somatex Medical Technologies GmbH
May 22, 2017 Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 0048060... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, It... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Co... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Num... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepP... When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... Class II Beckman Coulter Inc.
May 22, 2017 Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonste... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... Lack of sterility assurance. Class II Creganna Medical Devices
May 22, 2017 ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Leng... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, 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.