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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

28,992medical device recall records

2,381FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1051

28,992 detailed records are currently available in this category.

Medical DeviceAug 17, 2016

Ivoclar Vivadent OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID recall — FDA Z-2373-2016

After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol,…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceAug 17, 2016

Philips Medical Systems (Cleveland) Ingenuity Core Computed Tomography X-ray systems is recall — FDA Z-2371-2016

Software defect causing intermittently slow response of Host.

Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceAug 17, 2016

BioMerieux SA NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are recall — FDA Z-2342-2016

Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.

Class IFDA: TerminatedBioMerieux SA

Medical DeviceAug 17, 2016

Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot recall — FDA Z-2377-2016

Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft…

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceAug 17, 2016

Intuitive Surgical STAPLER 30, IS4000, model number 470430 recall — FDA Z-2349-2016

An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found…

Class IIFDA: TerminatedIntuitive Surgical, Inc.

Medical DeviceAug 17, 2016

Philips Medical Systems (Cleveland) Ingenuity Core128 Model No. 728323 recall — FDA Z-2384-2016

Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.

Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceAug 17, 2016

Edan Diagnostics EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70 recall — FDA Z-2388-2016

Incorrect CO2 readings with some patient monitors.

Class IIFDA: TerminatedEdan Diagnostics

Medical DeviceAug 10, 2016

Draeger Medical Oxylog 3000, Disposable Pediatric Patient Circuit recall — FDA Z-2215-2016

Isolated episodes of leakage at the check valve were found

Class IFDA: TerminatedDraeger Medical, Inc.

Medical DeviceAug 10, 2016

Beckman Coulter AU680 Chemistry Analyzers, Reference No recall — FDA Z-2309-2016

Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer,…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceAug 10, 2016

Zimmer Gmbh V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd recall — FDA Z-2323-2016

Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire…

Class IIFDA: TerminatedZimmer Gmbh

Medical DeviceAug 10, 2016

Teleflex Medical Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only recall — FDA Z-2327-2016

The manufacturing and expiration dates are not printed on the blister pack label.

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceAug 10, 2016

Branan Medical AmediCheck Instant Test Cup, Part No recall — FDA Z-2311-2016

Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.

Class IIIFDA: TerminatedBranan Medical Corporation

Medical DeviceAug 10, 2016

Zimmer Air Dermatome II Width Plate, 2 inch recall — FDA Z-2337-2016

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Class IIFDA: TerminatedZimmer Surgical Inc.

Medical DeviceAug 10, 2016

Medtronic Navigation S7 MACH FrameLink. The software application is sent in CD format with recall — FDA Z-2315-2016

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

Class IIFDA: TerminatedMedtronic Navigation, Inc.

Medical DeviceAug 10, 2016

AccessClosure, Inc., A Cardinal Health Company 6F/7F MynxGrip Vascular Closure Device recall — FDA Z-2329-2016

A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Class IIFDA: TerminatedAccessClosure, Inc., A Cardinal Health Company

Medical DeviceAug 10, 2016

Spacelabs Healthcare 91496 Ultraview SL Command Module, Options A, B, C, and I recall — FDA Z-2343-2016

The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the…

Class IIFDA: TerminatedSpacelabs Healthcare Inc.

Medical DeviceAug 10, 2016

Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X recall — FDA Z-2255-2016

Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the…

Class IIFDA: OngoingOlympus Scientific Solutions Americas

Medical DeviceAug 10, 2016

Medtronic Navigation FrameLink. The software application is sent in CD format with an IFU recall — FDA Z-2314-2016

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

Class IIFDA: TerminatedMedtronic Navigation, Inc.

Medical DeviceAug 10, 2016

Merge PACS software recall — FDA Z-2301-2016

Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceAug 10, 2016

Roche Diagnostics Operations ONLINE TDM Vancomycin 100 tests recall — FDA Z-2304-2016

Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method…

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

Medical DeviceAug 10, 2016

Medtronic Navigation Synergy Cranial S7 recall — FDA Z-2313-2016

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

Class IIFDA: TerminatedMedtronic Navigation, Inc.

Medical DeviceAug 10, 2016

Zimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01 recall — FDA Z-2335-2016

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Class IIFDA: TerminatedZimmer Surgical Inc.

Medical DeviceAug 10, 2016

Merge HEMO software recall — FDA Z-2341-2016

The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceAug 10, 2016

Zimmer Air Dermatome II Width Plate, 1.5 inch recall — FDA Z-2338-2016

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Class IIFDA: TerminatedZimmer Surgical Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.