Browse Device Recalls

1,503 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,503 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 1,503 FDA device recalls in FL.

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DateProductReasonClassFirm
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.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... 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, general & plastic surgery, labe... 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, gastroenterological & urologica... 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, general hospital use, labeled 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, cardiac, labeled as: a) HEAR... 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, Obstetrical & Gynecological use... 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, Obstetrical & Gynecological use... 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, general hospital use, labeled 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, gastroenterological & urologica... 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, general & plastic surgery, labe... 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, cardiac, labeled as: a) CENT... 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, Obstetrical & Gynecological use... 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, ear, nose & throat, labeled as:... 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.