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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.

28,535medical device recall records

2,363FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1035

28,535 detailed records are currently available in this category.

Medical DeviceSep 28, 2016

Global Healthcare MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer recall — FDA Z-2870-2016

The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.

Class IIFDA: TerminatedGlobal Healthcare Inc.

Medical DeviceSep 28, 2016

McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving recall — FDA Z-2872-2016

The STAT priority icon was not displayed in the Study List when the study was opened.

Class IIFDA: TerminatedMckesson Medical Imaging Group

Medical DeviceSep 28, 2016

Siemens Medical Solutions USA Syngo.x picture archiving and communication system Syngo.x is recall — FDA Z-2852-2016

Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceSep 28, 2016

TriMed Semi-Tubular Plate, 10-Hole, Model No recall — FDA Z-2849-2016

TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.

Class IIFDA: TerminatedTrimed Inc.

Medical DeviceSep 28, 2016

CooperSurgical Sage In-Vitro Fertilization- CSC recall — FDA Z-2850-2016

Products contain international package insert and not the correct USA package insert

Class IIIFDA: TerminatedCooperSurgical, Inc.

Medical DeviceSep 28, 2016

OrthoPediatrics 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics recall — FDA Z-2844-2016

OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.

Class IIFDA: TerminatedOrthoPediatrics Corp

Medical DeviceSep 28, 2016

AMO SENSAR 1-Piece IOL, Model No recall — FDA Z-2860-2016

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)

Medical DeviceSep 28, 2016

The Anspach Effort G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M recall — FDA Z-2840-2016

The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceSep 28, 2016

Carefusion 2200 Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module recall — FDA Z-2846-2016

The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly…

Class IIFDA: TerminatedCarefusion 2200 Inc.

Medical DeviceSep 28, 2016

AMO TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No recall — FDA Z-2863-2016

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)

Medical DeviceSep 28, 2016

OrthoPediatrics 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics recall — FDA Z-2843-2016

OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.

Class IIFDA: TerminatedOrthoPediatrics Corp

Medical DeviceSep 28, 2016

Merge Healthcare CADstream software recall — FDA Z-2871-2016

An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceSep 28, 2016

CooperSurgical Sage In-Vitro Fertilization- CSC recall — FDA Z-2851-2016

Products contain international package insert and not the correct USA package insert

Class IIIFDA: TerminatedCooperSurgical, Inc.

Medical DeviceSep 28, 2016

Siemens Medical Solutions USA Syngo.via picture archiving and communication system Syngo via recall — FDA Z-2853-2016

Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceSep 28, 2016

Merge Cardio software recall — FDA Z-2865-2016

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceSep 28, 2016

Sorin Group USA St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung recall — FDA Z-2866-2016

Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceSep 28, 2016

AMO TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No recall — FDA Z-2862-2016

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)

Medical DeviceSep 28, 2016

AMO TECNIS 1-Piece IOL, Model No recall — FDA Z-2858-2016

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)

Medical DeviceSep 28, 2016

Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor recall — FDA Z-2875-2016

Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

Class IIFDA: TerminatedPentax of America Inc.

Medical DeviceSep 28, 2016

Carefusion 2200 Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of recall — FDA Z-2847-2016

The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly…

Class IIFDA: TerminatedCarefusion 2200 Inc.

Medical DeviceSep 28, 2016

Philips Electronics HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A recall — FDA Z-2842-2016

The handle can separate from the MRx housing due to breakage of mounts on the rear case.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceSep 28, 2016

EKOS recall — FDA Z-2854-2016

The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant…

Class IIFDA: TerminatedEKOS Corporation

Medical DeviceSep 28, 2016

Siemens Healthcare Diagnostics IG1, IGF-I reagent, Catalog # LKGF1 recall — FDA Z-2841-2016

24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceSep 28, 2016

AMO TECNIS Multifocal 1-Piece Intraocular Lens, Model No recall — FDA Z-2856-2016

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)

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.