Browse Device Recalls
1,516 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,516 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 1,516 FDA device recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 25, 2015 | Titanium Square Uniscrew Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | IOL Transfer Impression Coping Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Gingihue 15 Degree Pre-Angled Post Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Gingihue Post Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Gingihue TM 15 degree Angled Post Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | MAKOplasty Hip Array Kit Laminate 150230 | Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array ... | Class II | Mako Surgical Corporation |
| Nov 25, 2015 | Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Ansp... | Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, R... | Class II | The Anspach Effort, Inc. |
| Nov 25, 2015 | Certain EP Twist Lock TM Coping Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental imp... | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Preformance Temporary Cylinder Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Preformance Post Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Conical Abutment Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Locator Light Retention Replacement Males 4pk Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Conical Abutment Gold Standard ZR TM Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Gold Slotted Screw Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Locator Replacement Males 4pk Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Temporary Hexed Cylinder Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Twist Lock TM Coping Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Denta... | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | IOL Distal Extension Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Standard Abutment Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | IOL Healing Cap Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Gold-Tite Square Uniscrew Item: UNISG Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item:... | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Gingihue 15 degree Angled Post Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Pick-up Coping Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | DAL-RO Abutment Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain EP Pick-Up Coping Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | DAL-RO Housing, Female Assembly Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G ... | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Conical EP Twist Lock TM Coping Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Micromini Flat Implant Cover Screw Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Preformance 15 degrees Pre-Angled Post Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Conical EP Healing Cap Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Bellatek Encode Healing Abutment Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Conical 17 degree Angled Abutment Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental impl... | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Conical 25 degree Angled Abutment Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Provide Protection Cap Dental implants | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 25, 2015 | Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 ... | Pouches may not have been sealed during packing. | Class II | Biomet 3i, LLC |
| Nov 16, 2015 | Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vial... | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... | Class II | Nephron Pharmaceuticals Corp. |
| Nov 16, 2015 | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vial... | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... | Class II | Nephron Pharmaceuticals Corp. |
| Nov 16, 2015 | Radiographic Transparency for Certain and External Connection Tapered Implant... | Images contained within radiographic transparency ART 1036 are undersized. | Class II | Biomet 3i, LLC |
| Nov 2, 2015 | Irrigation Clip 30; Intended to position and hold irrigation tubing during su... | Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). | Class II | The Anspach Effort, Inc. |
| Oct 22, 2015 | Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Te... | Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit a... | Class II | Mercury Enterprises, Inc. dba Mercury Medical |
| Oct 19, 2015 | The system provides the ability to transmit patient data files for storage, v... | Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze | Class II | Invivo Corporation |
| Oct 1, 2015 | The "Pacifier Activated Lullaby" (PAL) System composed of three major compone... | PAL unit has undergone significant technological changes since the previous 510(k) and labeling i... | Class II | Powers Medical Devices, LLC |
| Sep 28, 2015 | Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Su... | Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella ... | Class II | Exactech, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.