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 |
|---|---|---|---|---|
| Oct 3, 2013 | Invivo Corporation Expression IP5 Information Portal Product Usage: T... | Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expres... | Class II | Invivo Corporation |
| Oct 3, 2013 | ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bo... | Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitut... | Class III | Biomet 3i, LLC |
| Oct 2, 2013 | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for ... | Manufactured with an incorrect factory set unit of measure. | Class II | Nipro Diagnostics, Inc. |
| Oct 2, 2013 | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for ... | Manufactured with an incorrect factory set unit of measure. | Class II | Nipro Diagnostics, Inc. |
| Sep 27, 2013 | Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of ... | Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orie... | Class II | Cordis Corporation |
| Sep 20, 2013 | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa... | Product mix occurred prior to final package and labeling process. | Class II | Biomet Microfixation, LLC |
| Sep 11, 2013 | ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm ... | Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in... | Class II | Exactech, Inc. |
| Sep 6, 2013 | DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms... | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... | Class II | Winco Mfg., LLC |
| Sep 6, 2013 | CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholste... | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... | Class II | Winco Mfg., LLC |
| Sep 6, 2013 | XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold... | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... | Class II | Winco Mfg., LLC |
| Sep 6, 2013 | PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table option... | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... | Class II | Winco Mfg., LLC |
| Aug 29, 2013 | BIOMET 3i Endosseous Dental Implant. | Due to residual machining fluid identified by discoloration (darker in appearance) on the externa... | Class II | Biomet 3i, LLC |
| Aug 26, 2013 | Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL... | Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. | Class II | Biomet 3i, LLC |
| Aug 23, 2013 | Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e... | One lot of the product was assembled using the Cam Head version of the same prosthesis instead of... | Class II | Medtronic Xomed, Inc. |
| Aug 21, 2013 | SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cut... | No antibacterial bandages were packed in boxes labeled as antibacterial. | Class II | ASO, LLC |
| Aug 12, 2013 | Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introd... | Due to a labeling error related to the conversion of the inner diameter of the catheter from inch... | Class II | Cordis Corporation |
| Jul 26, 2013 | Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 ... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used ... | The device was not appropriately set to mitigate the risk of implant fracture upon rotation insid... | Class II | Atlas Spine, Inc. |
| Jul 26, 2013 | TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. S... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. ... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in.... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 22, 2013 | Contra-Angle Torque Driver Kit For Certain and External Connection Product... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Navigator Surgical Kit Product Usage: Molded plastic tray used in holding... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 9, 2013 | Tray Surgical, ENT (various instrument trays) Used for stot age and transp... | The firm will recall and replace the identified instrument trays in the field, with trays that ha... | Class II | Medtronic Xomed, Inc. |
| Jul 1, 2013 | MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an opti... | The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate v... | Class I | Iradimed Corporation |
| Jun 27, 2013 | MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25-... | The product was registered and distributed as a Class I medical device and was subsequently deter... | Class II | Insight Instruments, Inc. |
| Jun 10, 2013 | Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product ... | One of the dental implants do not have the internal hex feature. One of the dental implants do n... | Class II | Biomet 3i, LLC |
| Jun 10, 2013 | Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant ... | One of the dental implants do not have the internal hex feature. One of the dental implants do n... | Class II | Biomet 3i, LLC |
| Jun 5, 2013 | PANTERA Proximal Humerus Fracture Plate System | Potential suture clip breaking during a humerus fixation surgery. | Class II | Toby Orthopaedics, Inc. |
| May 30, 2013 | ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irr... | Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... | Class II | Linvatec Corp. dba ConMed Linvatec |
| May 30, 2013 | ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for j... | Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Co... | Class II | Linvatec Corp. dba ConMed Linvatec |
| May 30, 2013 | Exactech Articulated Driver A nonpowered hand-held device intended for me... | When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift ou... | Class II | Exactech, Inc. |
| May 23, 2013 | Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthe... | Failure to submit a premarket submission and gain approval of a medical device. | Class II | Pinook-Usa |
| May 23, 2013 | Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthe... | Failure to submit a premarket submission and gain approval of a medical device. | Class II | Pinook-Usa |
| May 16, 2013 | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) | Potential to electrostatic discharged (ESD) | Class II | HeartWare Inc |
| May 10, 2013 | Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) | A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... | Class II | Biomet 3i, LLC |
| May 10, 2013 | Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (... | A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, ... | Class II | Biomet 3i, LLC |
| May 6, 2013 | Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachm... | Product did not reach expected sterility assurance level | Class II | The Anspach Effort, Inc. |
| May 4, 2013 | NIPRO Safe Touch Safety Scalp Vein Set | There is a possibility of a crack in the CP luer connector. The position of the crack is at the c... | Class II | Nipro Medical Corporation |
| Apr 30, 2013 | AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ ... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 30, 2013 | EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medication... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
| Apr 30, 2013 | EZ Breathe Medication Cup. For the delivery of liquid medications for resp... | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking ... | Class I | Nephron Pharmaceuticals Corp. |
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.