Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 11, 2015 | Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 9, 2015 | Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUN... | One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced... | Class II | Smith & Nephew, Inc. |
| Nov 6, 2015 | MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; T... | Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE ... | Class II | Cardica, Inc. |
| Nov 6, 2015 | Destination Renal Guiding Sheath Intended for the introduction of interven... | Based on internal investigation and testing that revealed the distal end of certain lots of Terum... | Class II | Terumo Medical Corporation |
| Nov 4, 2015 | Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part N... | Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation... | Class II | Ormco/Sybronendo |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 6523002... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Oct 30, 2015 | RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx ... | An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner ... | Class II | BioHorizons Implant Systems Inc |
| Oct 27, 2015 | Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS... | It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - ... | Class III | Lab Vision Corporation |
| Oct 26, 2015 | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable impl... | The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... | Class II | Merz North America, Inc. |
| Oct 26, 2015 | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated fo... | The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... | Class II | Merz North America, Inc. |
| Oct 26, 2015 | MiniArc Pro Single incision Sling System, Model number / Product Reference 90... | The lot number on the outer carton label did not match the lot number printed on the tray label o... | Class II | Astora |
| Oct 26, 2015 | PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) I... | The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... | Class II | Merz North America, Inc. |
| Oct 9, 2015 | miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Han... | Update to labeling for the miraDry Console to remind users to only use approved lubricants in a t... | Class II | Miramar Labs, Inc. |
| Oct 8, 2015 | Merge OrthoCase software. The firm name on the label is Merge Healthcare, H... | Measurements in the software are changing after saving a plan with a measurement result, which ma... | Class II | Merge Healthcare, Inc. |
| Oct 8, 2015 | Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 t... | These lots of Oxygen Dial Regulators could have the settings label off by one position. When the ... | Class II | Precision Medical, Inc. |
| Oct 6, 2015 | 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes mod... | Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. | Class II | Synthes (USA) Products LLC |
| Oct 5, 2015 | MAMMOGRAPHY | Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ... | Class II | Avid Medical, Inc. |
| Oct 5, 2015 | Convenience Kits, MOHS "OPENING" PROCEDURE TRAY | Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ... | Class II | Avid Medical, Inc. |
| Oct 5, 2015 | Convenience Kits, MOHS "OPENING" PROCEDURE TRAY | Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ... | Class II | Avid Medical, Inc. |
| Oct 5, 2015 | PEDIATRIC KIDNEY BIOPSY TRAY | Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ... | Class II | Avid Medical, Inc. |
| Oct 2, 2015 | Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold i... | Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Cathet... | Class III | C.R. Bard, Inc. |
| Oct 1, 2015 | The "Pacifier Activated Lullaby" (PAL) System composed of three major compone... | PAL unit has undergone significant technological changes since the previous 510(k) and labeling i... | Class II | Powers Medical Devices, LLC |
| Sep 30, 2015 | BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 a... | Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. | Class III | Becton, Dickinson and Company, BD Biosciences |
| Sep 29, 2015 | TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 | Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they m... | Class II | Tekia, Inc. |
| Sep 29, 2015 | MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate... | The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter scr... | Class II | Biomet Spine, LLC |
| Sep 28, 2015 | Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Su... | Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella ... | Class II | Exactech, Inc. |
| Sep 28, 2015 | Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile... | The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.41... | Class II | Synthes (USA) Products LLC |
| Sep 22, 2015 | Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi... | Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Inject... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Sep 22, 2015 | Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the... | For sites using the Issuer of Patient ID (IPID), the system will display the study list and image... | Class II | Merge Healthcare, Inc. |
| Sep 21, 2015 | Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator,... | The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is ... | Class II | Valeant Pharmacueticals International |
| Sep 21, 2015 | TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indica... | One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (tota... | Class II | Biocompatibles U.K., Ltd. |
| Sep 21, 2015 | Custom Pak 9319-27. Single-use medical devices and accessories designed by m... | The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than th... | Class II | Alcon Research, Ltd. |
| Sep 18, 2015 | 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic cathete... | Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card... | Class II | Arrow International Inc |
| Sep 17, 2015 | Philips DuraDiagnost stationary X-ray system | Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which ca... | Class II | Philips Electronics North America Corporation |
| Sep 16, 2015 | Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For us... | The labeling is missing the size/diameter information. | Class II | Encore Medical, Lp |
| Sep 14, 2015 | MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 ... | The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packagin... | Class III | CooperSurgical, Inc. |
| Sep 14, 2015 | CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Pr... | CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels wh... | Class III | Biochemical Diagnostics Inc |
| Sep 14, 2015 | PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF... | The label on the lid stock of the individual needle packages for a portion of Lot number 46262 co... | Class II | Smiths Medical ASD, Inc. |
| Sep 11, 2015 | Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder ... | Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labe... | Class III | Acumedia Manufacturers, Inc. |
| Sep 3, 2015 | Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochem... | These Lot numbers are not stable up to the expiry date on the product labeling. | Class II | Leica Microsystems, Inc. |
| Sep 1, 2015 | CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Elect... | Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains ... | Class III | CooperSurgical, Inc. |
| Aug 31, 2015 | Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The S... | The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled M... | Class II | Synthes (USA) Products LLC |
| Aug 27, 2015 | CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Cata... | CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. | Class III | Becton, Dickinson and Company, BD Biosciences |
| Aug 27, 2015 | Zimmer Guide Wires for orthopedic procedures. | Product labeling of these sterile guide wires (external carton label and patient record label) st... | Class II | Zimmer, Inc. |
| Aug 24, 2015 | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Br... | Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot nu... | Class II | STERILMED, INC. |
| Aug 18, 2015 | Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-10... | The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the ... | Class II | Ecolab Inc |
| Aug 13, 2015 | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood... | Some 1 1/4" needles were packaged and labeled in the 1" blister package. | Class II | Nipro Medical Corporation |
| Aug 12, 2015 | FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:... | The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship... | Class III | Abbott Electrophysiology |
| Aug 10, 2015 | Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to ... | RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, ... | Class II | Biomet 3i, LLC |
| Aug 10, 2015 | Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attac... | The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a squa... | Class II | Biomet 3i, LLC |
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.