Medical DeviceFeb 17, 2016
Bard Distaflo Vascular Bypass Graft recall — FDA Z-0786-2016
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
29,496medical device recall records
2,407FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1114
29,496 detailed records are currently available in this category.
Medical DeviceFeb 17, 2016
Orthofix Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for recall — FDA Z-0797-2016
There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceFeb 17, 2016
C.R. Bard Arctic Sun 5000 and Arctic Sun 2000 recall — FDA Z-0760-2016
Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
Class IIFDA: TerminatedC.R. Bard, Inc.
Medical DeviceFeb 17, 2016
Toshiba American Medical Systems INFX-8000V Bi-Plane X-Ray Interventional System X-ray recall — FDA Z-0752-2016
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software.…
Class IIFDA: TerminatedToshiba American Medical Systems Inc.
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product recall — FDA Z-0773-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage recall — FDA Z-0777-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
Trumpf Medical Systems Patient transport Shuttle with Trendelenburg quick adjustment recall — FDA Z-0759-2016
Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
Class IIFDA: TerminatedTrumpf Medical Systems, Inc.
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product recall — FDA Z-0782-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
Del Medical VS200 radiographic Cassette Holder or Wall Stand recall — FDA Z-0761-2016
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Class IIFDA: TerminatedDel Medical, Inc.
Medical DeviceFeb 17, 2016
Merge Healthcare RadSuite, a picture archive and communications system recall — FDA Z-0794-2016
Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer recall — FDA Z-0775-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage recall — FDA Z-0774-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
Bard Distaflo Vascular Bypass Graft recall — FDA Z-0785-2016
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceFeb 17, 2016
GE Medical Systems GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System recall — FDA Z-0769-2016
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of…
Class IIFDA: TerminatedGE Medical Systems, LLC
Medical DeviceFeb 17, 2016
Philips Allura Xper FD20 Ceiling version only recall — FDA Z-0764-2016
Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product recall — FDA Z-0779-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage recall — FDA Z-0772-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
Zimmer Dental IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product recall — FDA Z-0784-2016
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and…
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceFeb 17, 2016
GE Medical Systems GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System recall — FDA Z-0770-2016
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of…
Class IIFDA: TerminatedGE Medical Systems, LLC
Medical DeviceFeb 17, 2016
Salter Labs T-piece Nebulizer with in-line connectors, Part number 8915-7-50 recall — FDA Z-0796-2016
Reports that the T-piece does not fit on the nebulizer.
Class IIFDA: TerminatedSalter Labs
Medical DeviceFeb 17, 2016
Accuray CyberKnife Robotic recall — FDA Z-0771-2016
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into…
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceFeb 17, 2016
Spectranetics 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power recall — FDA Z-0758-2016
The product is labeled with an expiration date that is past its shelf life.
Class IIFDA: TerminatedSpectranetics Corp.
Medical DeviceFeb 17, 2016
GE Medical Systems Mavig Monitor Suspension System, Model GD60, contained in the following recall — FDA Z-0763-2016
GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
Class IIFDA: TerminatedGE Medical Systems, LLC
Medical DeviceFeb 17, 2016
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative recall — FDA Z-0795-2016
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Class IIFDA: TerminatedPharmacaribe 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.