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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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1130

29,496 detailed records are currently available in this category.

Medical DeviceDec 16, 2015

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68 recall — FDA Z-0389-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

Philips IntelliVue Information Center iX recall — FDA Z-0374-2016

Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48 recall — FDA Z-0387-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48 recall — FDA Z-0380-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38 recall — FDA Z-0386-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26 recall — FDA Z-0390-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88 recall — FDA Z-0381-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

GE Medical Systems GE Healthcare, Revolution CT Scanners recall — FDA Z-0401-2016

GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with…

Class IIFDA: TerminatedGE Medical Systems, LLC

Medical DeviceDec 16, 2015

Philips Medical Systems (Cleveland) Brilliance CT (computed tomography) scanners, Big Bore recall — FDA Z-0400-2016

Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of…

Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceDec 16, 2015

BioHorizons Implant Systems RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF recall — FDA Z-0391-2016

An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

Class IIFDA: TerminatedBioHorizons Implant Systems Inc.

Medical DeviceDec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68 recall — FDA Z-0385-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

Synthes (USA) Products Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA recall — FDA Z-0375-2016

TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail…

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceDec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84 recall — FDA Z-0383-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

Zimmer Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona recall — FDA Z-0410-2016

Complaints that the ratchet teeth of the tube are not latching onto the rod.

Class IIFDA: TerminatedZimmer, Inc.

Medical DeviceDec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58 recall — FDA Z-0388-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78 recall — FDA Z-0382-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 16, 2015

Boston Scientific One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy recall — FDA Z-0402-2016

Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because…

Class IIFDA: TerminatedBoston Scientific Corp

Medical DeviceDec 16, 2015

Valeant Pharmaceuticals North America Model No recall — FDA Z-0371-2016

SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

Class IIFDA: TerminatedValeant Pharmaceuticals North America LLC

Medical DeviceDec 16, 2015

Visicu The eCareManager system recall — FDA Z-0399-2016

A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the…

Class IIFDA: TerminatedVisicu, Inc.

Medical DeviceDec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34 recall — FDA Z-0378-2016

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Class IIFDA: TerminatedLeMaitre Vascular, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper recall — FDA Z-0349-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper recall — FDA Z-0354-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper recall — FDA Z-0350-2016

Monitor Ceiling Suspension system may fall

Class IIFDA: TerminatedPhilips Medical Systems, Inc.

Medical DeviceDec 9, 2015

Merz PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable recall — FDA Z-0368-2016

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Class IIFDA: TerminatedMerz North America, 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.