Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Nov 29, 2016 Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with i... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/I... The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to ... Class II Synthes (USA) Products LLC
Nov 29, 2016 Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean In... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain w... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pedi... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual ch... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 29, 2016 symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C1... Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... Class II Symmetry Surgical, Inc.
Nov 29, 2016 Atrium Medical 400 Series Express Drains as follows: 4000-100N Express sing... Outer Packaging is not sterile Class II Atrium Medical Corporation
Nov 28, 2016 Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Ca... Cook Medical has received reports of the trays containing the incorrect needle, which in some cas... Class II Cook Inc.
Nov 28, 2016 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 4... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 4... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-8... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM M... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-8... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalo... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No.... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 4... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog ... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 Th... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 28, 2016 GoDirect Screw-Retaining Top Part Numbers: 4500-61 Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDi... Class II Implant Direct Sybron Manufacturing, LLC
Nov 28, 2016 XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 Th... Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV ... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Nov 25, 2016 Brilliance iCT Product Usage: Computed Tomography X-ray systems intended... Failure to correctly document the installation of four M12 Bolts into the system rotor. Class II Philips Medical Systems (Cleveland) Inc
Nov 23, 2016 AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335... Design error when displaying additional information in the patient view window; error may result ... Class II Radiometer America Inc
Nov 23, 2016 Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant ac... Drills cannot be inserted into handpiece due to tolerance specification not met Class II Straumann Manufacturing, Inc.
Nov 23, 2016 Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant ... Drills cannot be inserted into handpiece due to tolerance specification not met Class II Straumann Manufacturing, Inc.
Nov 23, 2016 MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS... A drift of the performance with the BK test (BK virus, worst case application) was observed for s... Class I BioMerieux SA
Nov 23, 2016 Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in ... Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage... Class II Medline Industries Inc
Nov 23, 2016 NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Prod... A drift of the performance with the BK test (BK virus, worst case application) was observed for s... Class I BioMerieux SA
Nov 23, 2016 Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and d... During use, the unit could separate un-expectantly. This failure would allow the patient's arm t... Class II Allen Medical Systems, Inc.
Nov 23, 2016 i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmac... The firm has initiated a product correction due to a bag carousel motor error causing misalignmen... Class II HEALTH ROBOTICS S.R.L.
Nov 22, 2016 G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9... During implantation, the proximal end of the device could separate if the angle between the devic... Class II Interventional Spine Inc
Nov 22, 2016 Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plat... There is a problem with the mating feature between the plate and screw which could cause the plat... Class II Amendia, Inc
Nov 22, 2016 SOMATOM Scope, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Conne... Class II Siemens Medical Solutions USA, Inc
Nov 22, 2016 CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/... Accuray has become aware of a potential safety issue involving unexpected treatment robot motion ... Class II Accuray Incorporated
Nov 22, 2016 SOMATOM Scope Power, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Conne... Class II Siemens Medical Solutions USA, Inc
Nov 22, 2016 Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx on... Product malfunction: Needle does not retract. Class II J&J Solutions, Inc. DBA Corvida Medical
Nov 22, 2016 SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) T... Siemens is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Pa... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2016 Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine l... Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the... Class II Reckitt Benckiser LLC
Nov 22, 2016 RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 ... Labeling Inconsistency: The products have been labeled with the incorrect expiration date which ... Class II Teleflex Medical
Nov 22, 2016 Ceres-C Standalone Cervical Interbody The product is a stand-alone anterio... Absent tantalum market pin. Class II Amendia, Inc
Nov 22, 2016 AbbVie PEG Kit 20 FR AbbVie is issuing an urgent field correction notification due to an increased number of reports o... Class II AbbVie Inc.
Nov 22, 2016 Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Ro... The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... Class II Amendia, Inc
Nov 22, 2016 Optimus Fixed Awl Complaints that the tip of the awl broke after impaction during surgery. Class II Amendia, Inc
Nov 22, 2016 Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through ... The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... Class II Amendia, Inc
Nov 22, 2016 Zeus-P Lumbar Interbody Device Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluat... Class II Amendia, Inc
Nov 22, 2016 SOMATOM Perspective, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connect... Class II Siemens Medical Solutions USA, Inc
Nov 22, 2016 Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm ... There is a problem with the mating feature between the plate and screw which could cause the plat... Class II Amendia, Inc
Nov 22, 2016 K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm... The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... Class II Amendia, 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.