Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1337

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

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 recall — FDA Z-0132-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 recall — FDA Z-0133-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 recall — FDA Z-0134-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product recall — FDA Z-0122-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 recall — FDA Z-0157-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

OriGen Biomedical Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO recall — FDA Z-0179-2019

These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip

Class IIFDA: TerminatedOriGen Biomedical, Inc.

Medical DeviceOct 24, 2018

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF recall — FDA Z-0108-2019

Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the…

Class IIFDA: TerminatedCarl Zeiss Meditec AG

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 recall — FDA Z-0156-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 recall — FDA Z-0159-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

CryoLife CryoPatch SG Pulmonary Hemi-Artery, 1 graft recall — FDA Z-0121-2019

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is…

Class IIFDA: TerminatedCryoLife, Inc.

Medical DeviceOct 24, 2018

Life Technologies Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for recall — FDA Z-0171-2019

Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

Class IIFDA: TerminatedLife Technologies, Corp.

Medical DeviceOct 24, 2018

Siemens Healthcare Diagnostics Atellica IM CKMB Master Curve Material, Cat No. 10995534 recall — FDA Z-0117-2019

A potential bias was identified with certain kits compared to the internal standards.

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 recall — FDA Z-0123-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 recall — FDA Z-0149-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 recall — FDA Z-0163-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product recall — FDA Z-0158-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 recall — FDA Z-0130-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Siemens Medical Solutions USA Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) recall — FDA Z-0178-2019

The terminals on the plug may become loose and overheat.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 24, 2018

Baxter Healthcare SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 recall — FDA Z-0107-2019

If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit…

Class IIFDA: TerminatedBaxter Healthcare Corporation

Medical DeviceOct 24, 2018

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188 recall — FDA Z-0176-2019

The service manual was not updated at the time of the release of software version 1.30.

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 recall — FDA Z-0127-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Siemens Healthcare Diagnostics Atellica Sample Handler Additional (SMN 11069004) recall — FDA Z-0191-2019

Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 24, 2018

Liko AB Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer recall — FDA Z-0105-2019

The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is used for patient transport, this could allow the patient to fall, resulting in…

Class IIFDA: TerminatedLiko AB

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 recall — FDA Z-0125-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

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