Medical DeviceAug 24, 2016
Biomet 3i Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental recall — FDA Z-2417-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
28,992medical device recall records
2,381FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1046
28,992 detailed records are currently available in this category.
Medical DeviceAug 24, 2016
ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog recall — FDA Z-2580-2016
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality…
Class IIIFDA: TerminatedORTHO-CLINICAL DIAGNOSTICS
Medical DeviceAug 24, 2016
AB Sciex API 3200MD" LC/MS/MS System recall — FDA Z-2526-2016
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Class IIFDA: TerminatedAb Sciex
Medical DeviceAug 24, 2016
Danville Materials Perioscopy Sheath: Part number: 1008 recall — FDA Z-2530-2016
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not…
Class IIFDA: TerminatedDanville Materials, Inc.
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 recall — FDA Z-2555-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab recall — FDA Z-2564-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
Biomet 3i Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental recall — FDA Z-2419-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item recall — FDA Z-2557-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
GE Healthcare It GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture recall — FDA Z-2579-2016
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a…
Class IIFDA: TerminatedGE Healthcare It
Medical DeviceAug 24, 2016
OraSure Technologies OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807 recall — FDA Z-2403-2016
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Class IFDA: TerminatedOraSure Technologies, Inc.
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab recall — FDA Z-2566-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
Synthes (USA) Products TI Single Vector Distractor Proximal Foot/Left recall — FDA Z-2586-2016
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab recall — FDA Z-2576-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512 recall — FDA Z-2535-2016
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
Class IIFDA: TerminatedStraumann Manufacturing, Inc.
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab recall — FDA Z-2571-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
Biomet 3i Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item recall — FDA Z-2409-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP recall — FDA Z-2577-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
Biomet 3i Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental recall — FDA Z-2509-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Baxter Healthcare Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and recall — FDA Z-2533-2016
Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or…
Class IIFDA: TerminatedBaxter Healthcare Corp.
Medical DeviceAug 24, 2016
LeMaitre Vascular 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm recall — FDA Z-2544-2016
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Class IIFDA: TerminatedLeMaitre Vascular, Inc.
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP recall — FDA Z-2575-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
Medical DeviceAug 24, 2016
LeMaitre Vascular 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product recall — FDA Z-2543-2016
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Class IIFDA: TerminatedLeMaitre Vascular, Inc.
Medical DeviceAug 24, 2016
Resmed Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with recall — FDA Z-2550-2016
Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.
Class IIFDA: TerminatedResmed Corporation
Medical DeviceAug 24, 2016
Medtronic Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP recall — FDA Z-2574-2016
Potential for compromise of the package resulting in a breach of the sterile barrier
Class IIFDA: TerminatedMedtronic
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.