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 |
|---|---|---|---|---|
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04020-C | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04120 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04018 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Co... | A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Ski... | Class II | ConvaTec, Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04122 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04020 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04220 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 24, 2017 | Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an ... | Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as... | Class II | Medtronic Minimally Invasive Therapies Group |
| Oct 23, 2017 | Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone. | The expiration date provided on the label is incorrect. | Class II | Smith & Nephew, Inc. |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx O... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Oct 18, 2017 | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... | Class II | Bioseal Corporation |
| Oct 17, 2017 | Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL... | Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 13, 2017 | Newton Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Rosen Curved Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | TFE Coated Curved Newton LLT | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Fixed Core Bentson | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Disposable Reuter Tip Deflecting Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Plus Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Fixed Core Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Central Venous Catheter Tray | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Extra Stiff Whisker Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Left Atrial Catheter Set | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device insi... | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. | Class II | Ecolab, Inc. |
| Oct 13, 2017 | Double Flexible Tipped Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Reuter Tip Deflecting Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Femoral Artery Pressure Monitoring Set | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Cerebral Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Ultra Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Extra Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Movable Core Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Coons Interventional Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 11, 2017 | Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manu... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 10, 2017 | MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Oct 10, 2017 | MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHE... | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Oct 10, 2017 | STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (out... | The label outside the cardboard box is labeled correctly but the pouches inside of some of the bo... | Class II | Karl Storz Endoscopy |
| 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 6, 2017 | Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz... | The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a ... | Class II | CooperSurgical, Inc. |
| Oct 3, 2017 | Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is e... | HighPuragar was mislabeled and inadvertently sold as Noble Agar. | Class II | Becton Dickinson & Co. |
| Oct 3, 2017 | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Num... | Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue ... | Class III | Degania Silicone, Ltd. |
| Oct 3, 2017 | Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arth... | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70... | Class II | Zimmer Biomet, 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. |
| Oct 2, 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... | The system may duplicate sample requests leading to sample misidentification when connected to a ... | Class II | Beckman Coulter Inc. |
| Sep 30, 2017 | Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is a... | Product was released to market without the adulteration strip included in the product. | Class III | Ameditech Inc |
| Sep 29, 2017 | Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Numb... | Knee implant components (tibial bearings) are labeled with the incorrect size. | Class II | Zimmer 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.