Medical DeviceDec 9, 2015
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 recall — FDA Z-0346-2016
Monitor Ceiling Suspension system may fall
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
29,496medical device recall records
2,407FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1131
29,496 detailed records are currently available in this category.
Medical DeviceDec 9, 2015
Procedure Products U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387 recall — FDA Z-0355-2016
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Class IIFDA: TerminatedProcedure Products, Inc.
Medical DeviceDec 9, 2015
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper recall — FDA Z-0348-2016
Monitor Ceiling Suspension system may fall
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 9, 2015
Carl Zeiss Meditec AG IOL Master 500: Software versions 7.5 and 7.7 recall — FDA Z-0358-2016
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Class IIFDA: TerminatedCarl Zeiss Meditec AG
Medical DeviceDec 9, 2015
Ormco/Sybronendo Copper NiTi Preformed Archwires recall — FDA Z-0343-2016
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Class IIFDA: TerminatedOrmco/Sybronendo
Medical DeviceDec 9, 2015
Philips Medical Systems Patient Support Material Number: 9890 010 87431 used with recall — FDA Z-0364-2016
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 9, 2015
Medtronic InSync III, model 8042, 8042B and 8042U recall — FDA Z-0342-2016
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Class IIFDA: TerminatedMedtronic Inc.
Medical DeviceDec 9, 2015
Philips Medical Systems Patient Support Material Number: 9890 010 87431, used recall — FDA Z-0365-2016
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 9, 2015
Baylis Medical Corp * ProTrack Microcatheter recall — FDA Z-0356-2016
Microcatheter may have circumferential defects (cracks) along its shaft.
Class IIFDA: TerminatedBaylis Medical Corp *
Medical DeviceDec 9, 2015
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) recall — FDA Z-0363-2016
These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small…
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceDec 9, 2015
Quest Medical Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat recall — FDA Z-0361-2016
The products have been found to intermittently exhibit a seal failure during use.
Class IIFDA: TerminatedQuest Medical, Inc.
Medical DeviceDec 9, 2015
DeRoyal Industries HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units recall — FDA Z-0345-2016
DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to…
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceDec 9, 2015
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series recall — FDA Z-0352-2016
Monitor Ceiling Suspension system may fall
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 9, 2015
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile recall — FDA Z-0362-2016
Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.
Medical DeviceDec 9, 2015
Merz Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1 recall — FDA Z-0366-2016
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.
Medical DeviceDec 9, 2015
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper recall — FDA Z-0353-2016
Monitor Ceiling Suspension system may fall
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 9, 2015
Stryker Medical Division of Stryker Two-stage and three-stage I.V. poles are shipped as an recall — FDA Z-0344-2016
It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which…
Class IIFDA: TerminatedStryker Medical Division of Stryker Corporation
Medical DeviceDec 9, 2015
ConMed Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) recall — FDA Z-0359-2016
Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to…
Class IIFDA: TerminatedConMed Corporation
Medical DeviceDec 9, 2015
Carl Zeiss Meditec AG IOL Master 5.5: Software versions 7.5 and 7.7 recall — FDA Z-0357-2016
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Class IIFDA: TerminatedCarl Zeiss Meditec AG
Medical DeviceDec 9, 2015
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series recall — FDA Z-0351-2016
Monitor Ceiling Suspension system may fall
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 9, 2015
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 recall — FDA Z-0347-2016
Monitor Ceiling Suspension system may fall
Class IIFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 9, 2015
Merz PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5 recall — FDA Z-0367-2016
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.
Medical DeviceDec 2, 2015
Synthes (USA) Products 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm recall — FDA Z-0323-2016
It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 2, 2015
Covidien Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 recall — FDA Z-0330-2016
Incorrectly packaged with a 90 degree bend at the distal tip
Class IIFDA: TerminatedCovidien LLC
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.