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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
Jan 5, 2018 Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use... Contains a gel-like contaminant that may affect product performance. Class III Diamedix Corporation
Dec 27, 2017 Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 2... Communication-connection error. Class II Mako Surgical Corporation
Dec 19, 2017 Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each devi... There is a possibility of the heparin line is occluded. Class II Nipro Medical Corporation
Dec 18, 2017 ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Cur... Package integrity failure observed during routine shift package integrity testing at an external ... Class II Johnson & Johnson Vision Care, Inc.
Dec 2, 2017 Sundream 12 V tanning bed The 30 minute maximum tanning time has been reduced to 20 minutes. Class II ProSun International, LLC
Dec 1, 2017 RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplast... Incorrect product and/or label. Sizing is labeled incorrectly. Class II Mako Surgical Corporation
Nov 20, 2017 Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonito... While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Win... Class II Invivo Corporation
Nov 15, 2017 Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated f... Potential for cracked luer hubs Class II Cordis Corporation
Oct 19, 2017 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses Some contact lenses were associated with complaints of a foreign matter caught between the bliste... Class II Johnson & Johnson Vision Care, Inc.
Oct 19, 2017 ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS Some contact lenses were associated with complaints of a foreign matter caught between the bliste... Class II Johnson & Johnson Vision Care, Inc.
Oct 19, 2017 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR Some contact lenses were associated with complaints of a foreign matter caught between the bliste... Class II Johnson & Johnson Vision Care, Inc.
Oct 9, 2017 Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Co... Wrong device description of the label identifying the implant Class II Exactech, Inc.
Oct 9, 2017 PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demon... Class II Inovo, Inc
Oct 3, 2017 iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR ... Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UF... Class II Arthrex, Inc.
Sep 29, 2017 OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/atta... This voluntary recall was initiated because a veterinary unit was physically shipped in error to ... Class II The Anspach Effort, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14,... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12,... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, ... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Aug 31, 2017 Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulde... Potentially mislabeled. 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.