Browse Device Recalls
1,506 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,506 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 1,506 FDA device recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Sep 23, 2015 | Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset,... | Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. | Class II | Exactech, Inc. |
| Sep 21, 2015 | BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC... | Inadequate biocompatibility testing. | Class II | Biomet 3i, LLC |
| Sep 21, 2015 | BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, ... | Inadequate biocompatibility testing. | Class II | Biomet 3i, LLC |
| Sep 21, 2015 | BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC6... | Inadequate biocompatibility testing. | Class II | Biomet 3i, LLC |
| Sep 21, 2015 | BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654,... | Inadequate biocompatibility testing. | Class II | Biomet 3i, LLC |
| Aug 13, 2015 | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood... | Some 1 1/4" needles were packaged and labeled in the 1" blister package. | Class II | Nipro Medical Corporation |
| Aug 10, 2015 | Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to ... | RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, ... | Class II | Biomet 3i, LLC |
| Aug 10, 2015 | Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attac... | The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a squa... | Class II | Biomet 3i, LLC |
| Aug 6, 2015 | Thinflap System Case The cases hold surgical instrumentation in place during... | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user withou... | Class II | Biomet Microfixation, LLC |
| Aug 6, 2015 | Neuro Combo Set Case The cases hold surgical instrumentation in place during... | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user withou... | Class II | Biomet Microfixation, LLC |
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.