Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

34151–34175 of 40449

HighFDA (Devices)·Z-0563-2015·2014-12-17
PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits
PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.
Product
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Product
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0579-2015·2014-12-17
ArthroCare Medical Recalls Ambient HipVac and KVac Wands for Sterile Barrier Breach
ArthroCare Medical Corporation is recalling 23,119 Ambient HipVac and KVac wands due to a potential breach of the sterile barrier caused by defective product trays.
Product
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0578-2015·2014-12-17
Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negative Risk
Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement because it may cause false negative Legionella test results.
Product
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2015·2014-12-17
Snug Seat Recalls Crocodile Size 3 Walking Aids Due to Bolt Failure
Snug Seat Inc is recalling 726 Crocodile size 3 walking aids because bolts securing the handles could break, causing the handles to dislodge.
Product
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0522-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.
Product
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0536-2015·2014-12-17
Instrumed Recalls External Vein Strippers Due to Regulatory Non-Compliance
Instrumed International is withdrawing 479 external vein strippers because the company did not market them before 1976, failing to meet FDA pre-amendment requirements.
Product
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0528-2015·2014-12-17
Concentric Medical Recalls Trevo Pro 4 Stent Retrievers Due to Labeling Error
Concentric Medical is recalling 10 units of Trevo Pro 4 Stent Retrievers because they were shipped with non-U.S. instructions for use that did not align with U.S. indications.
Product
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0539-2015·2014-12-17
Instrumed Recalls Manual Trephines for Regulatory Compliance
Instrumed International is withdrawing 74 manual trephines from the market because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0513-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System
Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.
Product
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0525-2015·2014-12-17
Concentric Medical Recalls Distal Access Catheters Due to Incorrect Labeling
Concentric Medical is recalling 87 Distal Access Catheters because they were shipped with Directions for Use containing instructions for aspiration, which are only approved outside the US.
Product
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the…
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0514-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.
Product
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0532-2015·2014-12-17
Instrumed Recalls Uterine Tenaculum Hooks for Regulatory Compliance
Instrumed International is withdrawing 26 uterine tenaculum hooks because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0517-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Product
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0511-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Product
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0581-2015·2014-12-17
Conformis iTotal CR G2 Knee Replacement System Recalled for Incorrect Serial Numbers
ConforMIS, Inc. is recalling one unit of the iTotal CR G2 Knee Replacement System due to an incorrect serial number on the tibial insert packaging.
Product
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0543-2015·2014-12-17
Instrumed Recalls Cushing Burr Instruments for Regulatory Non-Compliance
Instrumed International is withdrawing Cushing burrs because the company failed to meet FDA requirements for marketing pre-amendment devices.
Product
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0512-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 total temporomandibular joint replacement systems because laser etching on the parts is wider and deeper than previously validated conditions.
Product
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0569-2015·2014-12-17
Stryker 1488 HD 3-Chip Camera Recall for Colored Screen Image
Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.
Product
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0510-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System
Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated.
Product
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0520-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Product
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0574-2015·2014-12-17
Zimmer Title 2 Bone Screw Remover Recalled for Weld Failure Risk
Zimmer, Inc. is recalling 14 Title 2 Bone Screw Remover instruments due to a risk that the weld may break during use, potentially delaying surgery.
Product
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0529-2015·2014-12-17
Cooper Vision Recalls Soft Contact Lenses Due to Incorrect Lens Axis
Cooper Vision Caribbean Corp. is recalling 1,170 soft contact lenses because portions of the lots may contain units with an incorrect lens axis condition.
Product
Soft Contact Lens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0570-2015·2014-12-17
Stryker 1488 HD 3-Chip Inline Camera Recalled for Colored Screen Image
Stryker Endoscopy is recalling 1,965 HD 3-Chip Inline Cameras because a colored screen image may occur in certain operating room environments.
Product
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0521-2015·2014-12-17
Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.
Product
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Category
Medical Device
Distribution
3 states

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34151–34175 of 40449