Medical DeviceDec 3, 2014
Dharma Cavity Varnish 15mL recall — FDA Z-0476-2015
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Class IIFDA: TerminatedDharma Research, Inc.
30,447medical device recall records
2,766FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1247
30,447 detailed records are currently available in this category.
Medical DeviceDec 3, 2014
Abbott Ireland Diagnostics Division ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 recall — FDA Z-0474-2015
17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls…
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
Medical DeviceDec 3, 2014
Summit Industries The J700 Floor Mounted Tube Stand (FMTS) is intended to support and recall — FDA Z-0468-2015
The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.
Class IIFDA: TerminatedSummit Industries Inc.
Medical DeviceDec 3, 2014
Toshiba American Medical Systems Cardiac Function Analysis Software Product Data No recall — FDA Z-0472-2015
Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis…
Class IIFDA: TerminatedToshiba American Medical Systems Inc.
Medical DeviceDec 3, 2014
Remel Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box recall — FDA Z-0465-2015
A reagent within the test may return false negative results.
Class IIFDA: TerminatedRemel Inc.
Medical DeviceDec 3, 2014
Market-Tiers Instructions for Use for the blue endo MOREsolution Electromechanical recall — FDA Z-2145-2014
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
Class IIFDA: TerminatedMarket-Tiers Inc.
Medical DeviceDec 3, 2014
Dharma Cavity Varnish with Fluoride recall — FDA Z-0475-2015
During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
Class IIFDA: TerminatedDharma Research, Inc.
Medical DeviceDec 3, 2014
Intuitive Surgical 8MM,BLACK DIAMOND MICRO FORCEPS recall — FDA Z-0429-2015
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceDec 3, 2014
Intuitive Surgical 8MM,LARGE NEEDLE DRIVER recall — FDA Z-0428-2015
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceDec 3, 2014
Intuitive Surgical 8MM PERMANENT CAUTERY SPATULA recall — FDA Z-0437-2015
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceDec 3, 2014
Respironics California Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The recall — FDA Z-0485-2015
If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may…
Class IIFDA: TerminatedRespironics California Inc.
Medical DeviceDec 3, 2014
Novadaq Technologies LUNA Chest, Model No recall — FDA Z-0469-2015
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Class IIIFDA: TerminatedNovadaq Technologies, Inc.
Medical DeviceDec 3, 2014
Philips Medical Systems (Cleveland) IntelliSpace Portal DX/HX/EX recall — FDA Z-0473-2015
Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceDec 3, 2014
Intuitive Surgical 8MM, SMALL GRASPING RETRACTOR recall — FDA Z-0445-2015
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceDec 3, 2014
Intuitive Surgical 8MM,PROGRASP FORCEPS recall — FDA Z-0432-2015
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceDec 3, 2014
Novadaq Technologies Non-sterile drape recall — FDA Z-0470-2015
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Class IIIFDA: TerminatedNovadaq Technologies, Inc.
Medical DeviceDec 3, 2014
Intuitive Surgical 8MM FENESTRATED BIPOLAR FORCEPS recall — FDA Z-0438-2015
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceDec 3, 2014
ZOLL Circulation 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen recall — FDA Z-0477-2015
After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not…
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceDec 3, 2014
Intuitive Surgical 8MM, ATRIAL RETRACTOR SHORT RIGHT recall — FDA Z-0442-2015
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceDec 3, 2014
Zimmer Trabecular Metal Tibial Impactor recall — FDA Z-0423-2015
To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor…
Class IIFDA: TerminatedZimmer, Inc.
Medical DeviceDec 3, 2014
Toshiba American Medical Systems Cardiac Function Analysis Software Product Data No recall — FDA Z-0471-2015
Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis…
Class IIFDA: TerminatedToshiba American Medical Systems Inc.
Medical DeviceDec 3, 2014
Materialise USA Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) recall — FDA Z-0418-2015
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification:…
Class IIFDA: TerminatedMaterialise USA LLC
Medical DeviceDec 3, 2014
Philips Medical Systems Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C recall — FDA Z-0206-2015
Mold on gel filled Gel-E and Squishon products
Class IFDA: TerminatedPhilips Medical Systems, Inc.
Medical DeviceDec 3, 2014
CooperSurgical LEEP RADIUS LOOP ELECTRODE recall — FDA Z-0484-2015
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Class IIFDA: TerminatedCooperSurgical, 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.