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 |
|---|---|---|---|---|
| Dec 31, 2024 | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G ... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Dec 20, 2024 | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-... | Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). | Class II | Integrity Implants Inc. |
| Dec 10, 2024 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Pa... | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized ... | Class I | Mercury Enterprises, Inc. dba Mercury Medical |
| Dec 6, 2024 | Temporary Titanium Abutments | Certain definitive dental implant restoration cases may have included a temporary titanium abutme... | Class II | DDS Lab |
| Nov 27, 2024 | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot... | The devices were inadvertently shipped after their expiration date. | Class II | 3B Medical, Inc. |
| Aug 30, 2024 | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric em... | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. | Class I | Mercury Enterprises, Inc. dba Mercury Medical |
| Jul 16, 2024 | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF... | Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec C... | Class III | Beckman Coulter, Inc. |
| Jul 12, 2024 | NavaClick Syringe and Needle, Model Number LIN02 | Incorrect GTIN number on carton. | Class III | LINEAGE BIOMEDICAL, INC |
| Jul 5, 2024 | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | Class II | Medtronic Xomed, Inc. |
| Jun 24, 2024 | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... | Potential for false negative response on the NIM Vital Nerve Monitoring System | Class I | Medtronic Xomed, Inc. |
| Jun 2, 2024 | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System co... | Potential issue causing a higher frequency of interference with locking screws and/or inserter ro... | Class II | Treace Medical Concepts, Inc. |
| May 20, 2024 | Pink Luminous Breast, Breast transilluminator | Firm is marketing and distributing the Pink Luminous Breast device without premarket approval | Class II | Silkprousa LLC |
| Apr 26, 2024 | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numb... | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specif... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-2... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26M... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Apr 18, 2024 | OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26... | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 3... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mate... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 3... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, I... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 4... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, S... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, It... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b)... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mat... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Feb 22, 2024 | RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graf... | The stent-graft inside the delivery system was the incorrect size. | Class II | Bolton Medical Inc. |
| Dec 19, 2023 | REV 2 Flowcell Capsule Spare, Part Number: C04154 | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, Inc. |
| Dec 19, 2023 | iQ Waste Well Adapter, Part Number: 700-3393 | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, Inc. |
| Dec 19, 2023 | iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 7... | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, Inc. |
| Dec 19, 2023 | Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C7... | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Othopedic use, labeled as: a... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Ophthalmic use, labeled as: ... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, anesthesia, labeled as: a) H... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, urological, labeled as: a) U... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, 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.