Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Apr 5, 2024 WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedi... The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titan... Class II Wishbone Medical, Inc.
Apr 1, 2024 EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Devices may contain elevated levels of bacterial endotoxin. Class II Cook Medical Incorporated
Apr 1, 2024 EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 Devices may contain elevated levels of bacterial endotoxin. Class II Cook Medical Incorporated
Mar 28, 2024 NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of ... Out of specification violation of devices that results in a gap existing within the fixture that ... Class II Zimmer, Inc.
Mar 25, 2024 AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to ... Class I SonarMed Inc
Mar 21, 2024 AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indic... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated f... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indica... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indica... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 13, 2024 Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... Class II Biomet, Inc.
Mar 12, 2024 ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... Product incorrectly labelled. Class II DePuy Orthopaedics, Inc.
Mar 1, 2024 Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts f... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Trocar Needle - Used for dilating puncture sites or catheter tracts for percu... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous f... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator - Intended to be used for dilating puncture sites or catheter tracts ... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Peel-Away Introducer - Intended for the percutaneous introduction of balloon,... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Dec 21, 2023 FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t... Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati... Class II G & H Wire Company
Dec 7, 2023 MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Numb... The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static ... Class II Cook Medical Llc
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessf... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, 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.