Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1692

The newest recall records with useful source details are listed here.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product recall — FDA Z-1174-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product recall — FDA Z-1173-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702 recall — FDA Z-1240-2017

The single use devices are provided sterile and do not have an expiration date on the label.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMar 1, 2017

Reckitt Benckiser Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine recall — FDA Z-1249-2017

Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.

Class IIFDA: TerminatedReckitt Benckiser LLC

Medical DeviceMar 1, 2017

Biomet U.K Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments recall — FDA Z-1154-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for recall — FDA Z-1170-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for recall — FDA Z-1168-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706 recall — FDA Z-1244-2017

The single use devices are provided sterile and do not have an expiration date on the label.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMar 1, 2017

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care recall — FDA Z-1246-2017

Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial recall — FDA Z-1165-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage recall — FDA Z-1159-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Applied Medical Technology AMT 12 inch Right Angle Feeding Set with Y-Port Used with recall — FDA Z-1224-2017

Expired expiration dates are listed on the pouches.

Class IIIFDA: TerminatedApplied Medical Technology Inc.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product recall — FDA Z-1172-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703 recall — FDA Z-1241-2017

The single use devices are provided sterile and do not have an expiration date on the label.

Class IIFDA: TerminatedSmith & Nephew, Inc.

Medical DeviceMar 1, 2017

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN recall — FDA Z-1247-2017

DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the…

Class IIIFDA: TerminatedDeRoyal Industries Inc.

Medical DeviceMar 1, 2017

Vascular Solutions GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide recall — FDA Z-1250-2017

Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.

Class IIFDA: TerminatedVascular Solutions, Inc.

Medical DeviceMar 1, 2017

Cardiovascular Systems DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 recall — FDA Z-1230-2017

CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

Class IIFDA: TerminatedCardiovascular Systems Inc.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage recall — FDA Z-1157-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Tosoh Smd Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting recall — FDA Z-1245-2017

Power outages causes reporting software to shutdown.

Class IIFDA: TerminatedTosoh Smd Inc.

Medical DeviceMar 1, 2017

BioMerieux SA ETEST XM256 (Cefuroxime), Foam: 506958-506918 recall — FDA Z-1226-2017

Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.

Class IIFDA: TerminatedBioMerieux SA

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage recall — FDA Z-1167-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use recall — FDA Z-1153-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product recall — FDA Z-1171-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

Medical DeviceMar 1, 2017

Biomet U.K Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage recall — FDA Z-1160-2017

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the…

Class IIFDA: TerminatedBiomet U.K., Ltd.

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