Medical DeviceNov 25, 2015
Ameditech 10-Panel Pipette Drug Screen, Item No recall — FDA Z-0299-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
29,496medical device recall records
2,407FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1133
29,496 detailed records are currently available in this category.
Medical DeviceNov 25, 2015
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) recall — FDA Z-0288-2016
Sterility of the product cannot be assured.
Class IIFDA: TerminatedCivco Medical Instruments Co. Inc.
Medical DeviceNov 25, 2015
Ameditech CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No recall — FDA Z-0304-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with recall — FDA Z-0289-2016
Sterility of the product cannot be assured.
Class IIFDA: TerminatedCivco Medical Instruments Co. Inc.
Medical DeviceNov 25, 2015
Ameditech DrugSmart 11 Test Cup, Item No. 61127D recall — FDA Z-0308-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
Ameditech THERMO FISHER 6 DRUG CASSETTE, Item No recall — FDA Z-0317-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
Synthes Application Instrument for Sternal ZIPFIX recall — FDA Z-0276-2016
Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceNov 25, 2015
Ameditech 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K recall — FDA Z-0301-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147 recall — FDA Z-0295-2016
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to…
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
Medical DeviceNov 25, 2015
CIVCO Sales Demo Kit recall — FDA Z-0290-2016
Sterility of the product cannot be assured.
Class IIFDA: TerminatedCivco Medical Instruments Co. Inc.
Medical DeviceNov 25, 2015
ErgoSafe Products, LLC (DBA) Prism Medical Prism Medical C-300 Consumer Ceiling Lift recall — FDA Z-0284-2016
Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use
Class IIFDA: TerminatedErgoSafe Products, LLC (DBA) Prism Medical
Medical DeviceNov 25, 2015
Fresenius Modified Mixer Motor recall — FDA Z-0296-2016
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to…
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
Medical DeviceNov 25, 2015
Ameditech 12-Panel Dip Drug Screen with adulterant, Item No recall — FDA Z-0302-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus recall — FDA Z-0287-2016
Sterility of the product cannot be assured.
Class IIFDA: TerminatedCivco Medical Instruments Co. Inc.
Medical DeviceNov 25, 2015
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 recall — FDA Z-0280-2016
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.
Class IIFDA: TerminatedCyberonics, Inc.
Medical DeviceNov 25, 2015
Ameditech Micro Screen 6 Panel Cup with Adult (AU), Item No recall — FDA Z-0313-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
Ameditech ArcPoint Labs 10 Panel Dip Screen (OXY), Item No recall — FDA Z-0303-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO recall — FDA Z-0286-2016
Sterility of the product cannot be assured.
Class IIFDA: TerminatedCivco Medical Instruments Co. Inc.
Medical DeviceNov 25, 2015
Ameditech 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K recall — FDA Z-0300-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip recall — FDA Z-0281-2016
Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.
Medical DeviceNov 25, 2015
Ameditech EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step recall — FDA Z-0310-2016
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class IIFDA: TerminatedAmeditech Inc.
Medical DeviceNov 25, 2015
TZ Medical SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate recall — FDA Z-0318-2016
During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
Class IIFDA: TerminatedTZ Medical Inc.
Medical DeviceNov 25, 2015
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101 recall — FDA Z-0294-2016
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to…
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
Medical DeviceNov 25, 2015
Precision Medical Easy Dial Oxygen Regulator, 168708D and 168715D recall — FDA Z-0272-2016
These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting…
Class IIFDA: TerminatedPrecision Medical, 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.