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FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

29,963medical device recall records

2,598FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1198

29,963 detailed records are currently available in this category.

Medical DeviceApr 29, 2015

Specialty Appliance Works MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown recall — FDA Z-1503-2015

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Class IIFDA: TerminatedSpecialty Appliance Works, Inc.

Medical DeviceApr 29, 2015

Churchill Medical Systems 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 recall — FDA Z-1469-2015

Potential for leaking caused by insufficient bond between needleless device and female luer.

Class IIFDA: TerminatedChurchill Medical Systems, Inc.

Medical DeviceApr 29, 2015

Specialty Appliance Works M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst recall — FDA Z-1506-2015

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Class IIFDA: TerminatedSpecialty Appliance Works, Inc.

Medical DeviceApr 29, 2015

Biomet Spine Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage recall — FDA Z-1465-2015

Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or…

Class IIFDA: TerminatedBiomet Spine, LLC

Medical DeviceApr 29, 2015

Exactech Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44 recall — FDA Z-1459-2015

Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

Class IIFDA: TerminatedExactech, Inc.

Medical DeviceApr 29, 2015

Specialty Appliance Works HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism recall — FDA Z-1507-2015

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Class IIFDA: TerminatedSpecialty Appliance Works, Inc.

Medical DeviceApr 29, 2015

Diasorin recall — FDA Z-1464-2015

Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.

Class IIFDA: TerminatedDiasorin Inc.

Medical DeviceApr 29, 2015

PhotoMedex Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or recall — FDA Z-1516-2015

The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to…

Class IIFDA: TerminatedPhotoMedex, Inc.

Medical DeviceApr 29, 2015

X Spine Systems Xpress System Pedicle Screw Assembly, 5.5 x 55mm recall — FDA Z-1512-2015

One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.

Class IIFDA: TerminatedX Spine Systems Inc.

Medical DeviceApr 29, 2015

Focus Diagnostics STRATIFY JCV DxSelect, Model No recall — FDA Z-1454-2015

Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential…

Class IIFDA: TerminatedFocus Diagnostics Inc.

Medical DeviceApr 29, 2015

Specialty Appliance Works LR Telescoping Cantilever Arms (5/pk) and LL Telescoping recall — FDA Z-1508-2015

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Class IIFDA: TerminatedSpecialty Appliance Works, Inc.

Medical DeviceApr 29, 2015

OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE recall — FDA Z-1456-2015

Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.

Class IFDA: TerminatedOriGen Biomedical, Inc.

Medical DeviceApr 29, 2015

Churchill Medical Systems 7" High Pressure Set with Bionector, Product Code: CMS-808 and recall — FDA Z-1473-2015

Potential for leaking caused by insufficient bond between needleless device and female luer.

Class IIFDA: TerminatedChurchill Medical Systems, Inc.

Medical DeviceApr 29, 2015

Churchill Medical Systems 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device recall — FDA Z-1472-2015

Potential for leaking caused by insufficient bond between needleless device and female luer.

Class IIFDA: TerminatedChurchill Medical Systems, Inc.

Medical DeviceApr 29, 2015

Specialty Appliance Works Herbst Universal Nut which is used in a Herbst Appliance A Herbst recall — FDA Z-1502-2015

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Class IIFDA: TerminatedSpecialty Appliance Works, Inc.

Medical DeviceApr 29, 2015

Thermedx Fluid Management System P4000 recall — FDA Z-1463-2015

To correct software bugs that could affect the ability to accurately measure fluid deficit.

Class IIFDA: TerminatedThermedx LLC

Medical DeviceApr 29, 2015

Musculoskeletal Transplant Foundation DBX Mix, 20 cc, Product Code: 058200 recall — FDA Z-1455-2015

The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.

Class IIFDA: TerminatedMusculoskeletal Transplant Foundation, Inc.

Medical DeviceApr 29, 2015

Specialty Appliance Works Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope recall — FDA Z-1510-2015

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Class IIFDA: TerminatedSpecialty Appliance Works, Inc.

Medical DeviceApr 29, 2015

Hospira The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or recall — FDA Z-1518-2015

The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.

Class IIFDA: TerminatedHospira Inc.

Medical DeviceApr 29, 2015

Specialty Appliance Works TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS recall — FDA Z-1509-2015

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Class IIFDA: TerminatedSpecialty Appliance Works, Inc.

Medical DeviceApr 29, 2015

Churchill Medical Systems Bifurcated set with check vales and Bionectors, Product Code recall — FDA Z-1476-2015

Potential for leaking caused by insufficient bond between needleless device and female luer.

Class IIFDA: TerminatedChurchill Medical Systems, Inc.

Medical DeviceApr 29, 2015

Churchill Medical Systems 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 recall — FDA Z-1475-2015

Potential for leaking caused by insufficient bond between needleless device and female luer.

Class IIFDA: TerminatedChurchill Medical Systems, Inc.

Medical DeviceApr 22, 2015

Nobel Biocare Usa NobelReplace CC PMC RP 5.0x13mm, Article No. 37298 recall — FDA Z-1440-2015

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Class IIFDA: TerminatedNobel Biocare Usa LLC

Medical DeviceApr 22, 2015

Nobel Biocare Usa Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107 recall — FDA Z-1424-2015

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Class IIFDA: TerminatedNobel Biocare Usa 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.