Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

15176–15200 of 21645

ModerateFDA (Devices)·Z-0842-2016·2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling 4,567 knee prosthesis units because the LDPE packaging bag adheres to the polished implant surface.
Product
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0829-2016·2016-03-02
Cardiac Science Defibrillation Electrodes Recalled for Impedance Issues
Cardiac Science is recalling specific defibrillation electrodes that may develop high electrical impedance, causing AED self-test failures.
Product
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0830-2016·2016-03-02
Zimmer Biomet Recalls LPS-FLEX GSF OPT Knee Prostheses Due to Packaging Defect
Zimmer Biomet is recalling LPS-FLEX GSF OPT knee prostheses because the LDPE bag adheres to the implant surface. The recall covers 84,396 units distributed worldwide.
Product
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0884-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0882-2016·2016-03-02
Stryker T2 Fixation K-Wire Recall Due to Packaging Seal Integrity Concerns
Stryker Howmedica Osteonics Corp. is recalling T2 Fixation K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0880-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased, potentially affecting sterility.
Product
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0831-2016·2016-03-02
Zimmer Biomet Recalls NexGen CR-FLEX Knee Implants Due to Packaging Defect
Zimmer Biomet is recalling NexGen CR-FLEX knee prostheses because the LDPE packaging bag adheres to the implant surface. The recall covers 42,064 units distributed worldwide.
Product
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0836-2016·2016-03-02
Zimmer Biomet Recalls Knee Prosthesis Due to Packaging Adhesion Issue
Zimmer Biomet is recalling Zimmer Uni High Flex Precoat Femoral knee prostheses because the LDPE packaging bag adheres to the implant surface.
Product
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0862-2016·2016-03-02
Siemens Recalls Syngo Plaza PACS Software Due to Display and Access Issues
Siemens is recalling 68 units of Syngo Plaza PACS software to fix bugs affecting image display, saving, and access controls.
Product
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0832-2016·2016-03-02
Zimmer Biomet Recalls NexGen LPS-FLEX Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS-FLEX femoral knee implants because the packaging bag adheres to the polished implant surface.
Product
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0834-2016·2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
Zimmer Biomet is recalling NexGen Knee LPS and Lock femoral components because the LDPE packaging bag adheres to the polished implant surface.
Product
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0725-2016·2016-03-02
Zydus Recalls Risperidone Tablets Due to Impurity Failure
Zydus Pharmaceuticals is recalling 9,504 bottles of 2 mg risperidone tablets because they failed impurity specifications. The affected lot is MP4967.
Product
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0881-2016·2016-03-02
Stryker T2 Guidewire Recalled for Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0845-2016·2016-03-02
Zimmer Biomet Recalls Bipolar Shell Hip Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 72,806 Bipolar Shell hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0835-2016·2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion Issue
Zimmer Biomet is recalling NexGen Knee femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0828-2016·2016-03-02
Stryker Aero-AL Impaction Handle Recalled for Jamming Defect
Stryker Spine is recalling 31 Aero-AL Impaction Handles due to reported jamming when assembled to the Inserter guide.
Product
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0848-2016·2016-03-02
Zimmer Biomet Recalls Versus Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 1,305 Versus 6-inch hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0877-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review indicated that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0878-2016·2016-03-02
Stryker T2 Guidewire Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0879-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
Product
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0872-2016·2016-03-02
Stryker Gamma3 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma3 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
Product
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0855-2016·2016-03-02
Stryker Vitallium Wire Recalled Due to Sterilization Labeling Error
Stryker is recalling Vitallium Wire because the instructions incorrectly state the non-sterile device is sterile, omitting required sterilization steps.
Product
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0753-2016·2016-03-02
GE Precision MPi X-ray System Recalled for Touch Panel Boot Issues
Regulatory Insight, Inc. is recalling 43 GE Precision MPi X-ray systems because the Remote Touch Panel may fail to boot up as intended.
Product
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0869-2016·2016-03-02
Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0876-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide