Browse Device Recalls
264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 264 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 264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 22, 2016 | RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 ... | Labeling Inconsistency: The products have been labeled with the incorrect expiration date which ... | Class II | Teleflex Medical |
| Nov 18, 2016 | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medica... | Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. | Class II | Teleflex Medical |
| Nov 16, 2016 | Weck Facial Closure Systems have application in laparoscopic procedures for ... | The devices wings may become partially detached from the EFx Shield during use. | Class II | Teleflex Medical |
| Nov 8, 2016 | ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow On... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Ar... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnCon... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow ... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufacture... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Oct 27, 2016 | LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: ... | Product Defect; These products may produce a straight stream instead of a fully atomized plume of... | Class II | Teleflex Medical |
| Oct 27, 2016 | FLEXI NOZZLE SHORT Product Usage: These products are used for the deliver... | Product Defect; These products may produce a straight stream instead of a fully atomized plume of... | Class II | Teleflex Medical |
| Oct 27, 2016 | FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These product... | Product Defect; These products may produce a straight stream instead of a fully atomized plume of... | Class II | Teleflex Medical |
| Oct 27, 2016 | LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Produc... | Product Defect; These products may produce a straight stream instead of a fully atomized plume of... | Class II | Teleflex Medical |
| Oct 27, 2016 | LMA MADdy, Rx only, Product Usage: These products are used for the deliv... | Product Defect; These products may produce a straight stream instead of a fully atomized plume of... | Class II | Teleflex Medical |
| Oct 27, 2016 | LMA MADomizer, Rx only, Product Usage: These products are used for the d... | Product Defect; These products may produce a straight stream instead of a fully atomized plume of... | Class II | Teleflex Medical |
| Oct 27, 2016 | Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with ... | Product Defect; These products may produce a straight stream instead of a fully atomized plume of... | Class II | Teleflex Medical |
| Oct 18, 2016 | Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed ... | Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units l... | Class II | Teleflex Medical |
| Sep 9, 2016 | Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile ... | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... | Class II | Teleflex Medical |
| Sep 9, 2016 | Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile... | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... | Class II | Teleflex Medical |
| Aug 26, 2016 | Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patie... | The connector may disconnect from the tracheostomy tube during use. | Class I | Teleflex Medical |
| Aug 24, 2016 | WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horiz... | Misbranded: Incorrect etching on the device. | Class II | Teleflex Medical |
| May 5, 2016 | Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.... | The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a... | Class II | Teleflex Medical |
| Mar 30, 2016 | Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08... | The label on the Tyvek bag is missing. This is used by customers to identify material code, lot ... | Class II | Teleflex Medical |
| Mar 24, 2016 | Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is ... | Incorrect expiration date was printed on the product label. | Class II | Teleflex Medical |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ I... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is util... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aort... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 2, 2016 | Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx O... | The clip in the applier may be missing a boss. A boss is the part of the clip that is used to ho... | Class II | Teleflex Medical |
| Dec 3, 2015 | MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusaha... | Cracking may occur at the 15mm and 22mm ISO female connector. | Class II | Teleflex Medical |
| Dec 3, 2015 | Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A he... | Cracks may occur at the 15mm and 22mm ISO female connector. | Class II | Teleflex Medical |
| Oct 14, 2015 | Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access p... | The defective component can cause gas leakage through the device. This can result in loss of pne... | Class II | Teleflex Medical |
| Aug 24, 2015 | R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx o... | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Class II | Teleflex Medical |
| Aug 24, 2015 | Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical. | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Class II | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 2... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, ... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| Jun 1, 2015 | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: ... | The double swivel connector may crack or separate on the endobronchial tube. | Class I | Teleflex Medical |
| May 14, 2015 | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Huds... | The intake port may be blocked which can cause the bag to fail to fill. | Class I | Teleflex Medical |
| Apr 1, 2015 | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. | Customer complaints were received of power to the unit ceasing and the display going blank. | Class II | Teleflex Medical |
| Mar 13, 2015 | Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Co... | Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant siz... | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adapt... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adapto... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Ad... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier ... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
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.