Browse Device Recalls
3,192 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,192 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 3,192 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 11, 2013 | 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRU... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELF... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 1, 2013 | Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stry... | Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was... | Class II | Stryker Howmedica Osteonics Corp. |
| Oct 1, 2013 | Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV I... | Class III | Helix Medical LLC |
| Sep 26, 2013 | 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics ... | The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marke... | Class II | OrthoPediatrics Corp |
| Sep 23, 2013 | Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont... | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ... | Class III | Alere San Diego, Inc. |
| Sep 10, 2013 | Dual Luer Lock Cap The device is intended for use as a cap for male or fem... | The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... | Class II | Baxter Healthcare Corp. |
| Sep 4, 2013 | Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... | The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... | Class II | Baxter Healthcare Corp. |
| Aug 28, 2013 | VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Herit... | Based on a review of historic packaging validations, it was determined that a subset of product p... | Class II | Zimmer, Inc. |
| Aug 28, 2013 | Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates Th... | Zimmer recently conducted a review of historic packaging validations completed. Based on this re... | Class II | Zimmer, Inc. |
| Jul 31, 2013 | "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors ... | The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ... | Class II | Edwards Lifesciences, LLC |
| Jul 30, 2013 | Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fi... | Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect label... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment... | The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole... | Class II | Synthes USA HQ, Inc. |
| Jul 30, 2013 | Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject P... | Complaints were received of inconsistencies in the expiration dates shown on the packaging of the... | Class II | Synthes USA HQ, Inc. |
| Jul 25, 2013 | STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization Sys... | The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (... | Class II | Advanced Sterilization Products |
| Jul 24, 2013 | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... | On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... | Class II | Gyrus Medical, Inc |
| Jul 24, 2013 | 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System ... | OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #913... | Class II | OrthoPediatrics Corp |
| Jul 19, 2013 | C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tiss... | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... | Class II | Atrium Medical Corporation |
| Jul 19, 2013 | C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficienc... | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... | Class II | Atrium Medical Corporation |
| Jul 19, 2013 | C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue... | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... | Class II | Atrium Medical Corporation |
| Jul 19, 2013 | C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue de... | Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner pac... | Class II | Atrium Medical Corporation |
| Jul 16, 2013 | Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Ste... | Zimmer recently conducted a review of historic packaging validations completed. Based on this re... | Class II | Zimmer, Inc. |
| Jul 8, 2013 | Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. | the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil ... | Class II | Baxter Healthcare Corp. |
| Jun 25, 2013 | ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:... | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... | Class III | Convatec Inc. |
| Jun 25, 2013 | ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f... | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... | Class III | Convatec Inc. |
| Jun 24, 2013 | SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... | The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... | Class II | Stelkast Co |
| Jun 19, 2013 | VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 4, 2013 | Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disp... | Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due ... | Class II | Utah Medical Products, Inc |
| Jun 3, 2013 | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... | Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon... | Class II | Alere San Diego, Inc. |
| May 31, 2013 | 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... | Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... | Class II | Karl Storz Endoscopy America Inc |
| May 23, 2013 | Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
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.