Medical DeviceMay 24, 2017
BioMerieux SA ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a recall — FDA Z-2095-2017
False susceptible results
Class IIFDA: TerminatedBioMerieux SA
28,065medical device recall records
2,353FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 955
28,065 detailed records are currently available in this category.
Medical DeviceMay 24, 2017
MEDLINE INDUSTRIES 16 mm Distraction Pin, Titanium, Qty: 1 per pack recall — FDA Z-2103-2017
Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of…
Class IIFDA: TerminatedMEDLINE INDUSTRIES Inc.
Medical DeviceMay 24, 2017
Sorin Group Italia SRL - CRF OVATIO Models: VR 6250, DR 6550, CRT 6750 recall — FDA Z-2112-2017
Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
Class IIFDA: TerminatedSorin Group Italia SRL - CRF
Medical DeviceMay 24, 2017
Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Stereotaxic instrument recall — FDA Z-2076-2017
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues…
Class IIFDA: TerminatedOrthosoft, Inc. dba Zimmer CAS
Medical DeviceMay 24, 2017
MEDLINE INDUSTRIES 12 mm Distraction Pin, Blunt Qty: 1 per pack recall — FDA Z-2107-2017
Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of…
Class IIFDA: TerminatedMEDLINE INDUSTRIES Inc.
Medical DeviceMay 24, 2017
Abbott Vascular NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12 recall — FDA Z-2038-2017
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Class IFDA: TerminatedAbbott Vascular
Medical DeviceMay 24, 2017
Medtest Holdings Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic recall — FDA Z-2116-2017
A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not…
Class IIIFDA: TerminatedMedtest Holdings, Inc.
Medical DeviceMay 24, 2017
MEDLINE INDUSTRIES 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack recall — FDA Z-2104-2017
Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of…
Class IIFDA: TerminatedMEDLINE INDUSTRIES Inc.
Medical DeviceMay 24, 2017
Zimmer Biomet NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total recall — FDA Z-2115-2017
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 24, 2017
Sorin Group Italia SRL - CRF INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage recall — FDA Z-2114-2017
Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
Class IIFDA: TerminatedSorin Group Italia SRL - CRF
Medical DeviceMay 24, 2017
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and recall — FDA Z-2096-2017
Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)
Medical DeviceMay 24, 2017
Eden Spine Europe SA GIZA Vertebral Body Replacement recall — FDA Z-2072-2017
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Class IIFDA: TerminatedEden Spine Europe SA
Medical DeviceMay 24, 2017
Siemens Healthcare Diagnostics ADVIA Centaur Systems Insulin Calibrator recall — FDA Z-2085-2017
Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values.…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 24, 2017
Aesculap Implant Systems GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 recall — FDA Z-2087-2017
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur.…
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceMay 24, 2017
Beckman Coulter Triglycerides Reagent (TG 2 x 300), Catalog No. 445850 recall — FDA Z-2083-2017
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 24, 2017
Abbott Vascular NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T recall — FDA Z-2039-2017
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Class IFDA: TerminatedAbbott Vascular
Medical DeviceMay 24, 2017
Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Orthopedic Stereotaxic recall — FDA Z-2075-2017
ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
Class IIIFDA: TerminatedOrthosoft, Inc. dba Zimmer CAS
Medical DeviceMay 24, 2017
Beckman Coulter Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785 recall — FDA Z-2079-2017
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 24, 2017
Hitachi Medical Systems Arietta 70 Ultrasound System Intended for use by trained personnel recall — FDA Z-2090-2017
The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Class IIFDA: TerminatedHitachi Medical Systems America Inc.
Medical DeviceMay 24, 2017
Sorin Group Italia SRL - CRF PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR recall — FDA Z-2113-2017
Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
Class IIFDA: TerminatedSorin Group Italia SRL - CRF
Medical DeviceMay 24, 2017
Ion Beam Applications S.A Proton therapy system -Proteus 235 aka Proteus Plus recall — FDA Z-2097-2017
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already…
Class IIFDA: TerminatedIon Beam Applications S.A.
Medical DeviceMay 24, 2017
VORTRAN Automatic Resuscitator, VARPlus recall — FDA Z-2091-2017
Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the…
Class IIFDA: TerminatedVortran Medical Technology 1, Inc.
Medical DeviceMay 24, 2017
MEDLINE INDUSTRIES 10 mm Distraction Pin, Aggressive Qty: 1 per pack recall — FDA Z-2105-2017
Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of…
Class IIFDA: TerminatedMEDLINE INDUSTRIES Inc.
Medical DeviceMay 24, 2017
Luminex ARIES System and ARIES M1 System recall — FDA Z-2094-2017
The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned…
Class IIFDA: TerminatedLuminex Corporation
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.