Hazard

Improper Placement recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 8
Critical: 0
Severe: 1
Most recent: 2023-09-27

Of the 8 improper placement recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all improper placement recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–8 of 8

HighFDA (Devices)·Z-2612-2023·2023-09-27
TyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement
Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.
Product
TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2610-2023·2023-09-27
TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions
Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.
Product
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0519-2021·2020-12-09
Bausch & Lomb Recalls Toric Intraocular Lenses Due to Missing Axis Marks
Bausch & Lomb is recalling 31 MX60ET toric intraocular lenses because they may be missing toric axis marks, which are necessary for proper surgical placement.
Product
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0073-2021·2020-10-14
Biomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
Biomet 3i, LLC is recalling BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.
Product
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-2445-2015·2015-09-02
FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect
Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.
Product
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2325-2015·2015-08-12
Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect
Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.
Product
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1960-2013·2013-08-21
Biomet 3i Dental Implant Recall Due to Outer Box Mislabeling
Biomet 3i is recalling 51 dental implants because outer boxes may be mislabeled. The implants themselves are correctly labeled, but the error could prevent proper placement.
Product
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1961-2013·2013-08-21
Biomet 3i Dental Implant Recall for Potential Outer Box Mislabeling
Biomet 3i is recalling 33 dental implants because outer boxes may be mislabeled. The inner trays are correctly labeled, but the error could prevent proper implant placement.
Product
Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Category
Medical Device
Distribution
1 state