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 |
|---|---|---|---|---|
| Feb 27, 2019 | MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with... | Administration sets leaked at the filter. | Class II | Zevex Incorporated (dba MOOG Medical Devices Gr... |
| Feb 27, 2019 | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF... | The device label incorrectly states that the device is sterile. This product is an externally app... | Class III | Teleflex Medical |
| Feb 22, 2019 | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ... | The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduc... | Class III | GE Healthcare, LLC |
| Feb 19, 2019 | smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 ... | Complaints were received indicating that the outer label incorrectly identified the product as si... | Class II | Smith & Nephew, Inc. |
| Feb 19, 2019 | smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZ... | Complaints were received indicating that the outer label incorrectly identified the product as si... | Class II | Smith & Nephew, Inc. |
| Feb 18, 2019 | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 15, 2019 | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 | The product does not meet sterility requirements. Product labeled as sterile was distributed wit... | Class II | COVIDIEN LLC |
| Feb 11, 2019 | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes in... | Packaged with an incorrect size inner cannula. | Class II | Smiths Medical ASD Inc. |
| Feb 8, 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The ... | The integrity of the sterile grid packaging is potentially compromised. | Class II | Riverpoint Medical, LLC |
| Feb 5, 2019 | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | Inner blister pack label is incorrect and does not match the correct external box label. | Class III | SPINEART SA |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Jan 31, 2019 | Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile,... | The product was mislabeled with an incorrect expiration date. | Class II | RHONDIUM LIMITED |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 28, 2019 | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOn... | Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Speci... | Class III | LivaNova USA Inc. |
| Jan 18, 2019 | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product U... | Cosmetic Kit was packaged with a mislabel medical product. | Class II | Bellus Medical |
| Jan 17, 2019 | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X... | On-X Valve was mislabeled with the incorrect serial number. | Class II | CryoLife, Inc. |
| Jan 17, 2019 | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expirati... | The product may not meet sterility requirements. Product labeled as sterile, however all units do... | Class II | DJO, LLC |
| Jan 16, 2019 | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as... | Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... | Class II | Polymer Technology Systems, Inc. |
| Jan 16, 2019 | Lipid Panel test strips (as a component of smart bundles), REF 2729, also pri... | Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... | Class II | Polymer Technology Systems, Inc. |
| Jan 14, 2019 | RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device | The device labels are not UDI compliant. The missing UDI compliance information on the labelling ... | Class III | Teleflex Medical |
| Jan 14, 2019 | RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device | The device labels are not UDI compliant. The missing UDI compliance information on the labelling ... | Class III | Teleflex Medical |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Jan 9, 2019 | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Due to a complaint received and internal investigation it was determined that implant vials were ... | Class II | Implant Direct Sybron Manufacturing LLC |
| Jan 9, 2019 | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled ... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Jan 9, 2019 | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Jan 4, 2019 | iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-... | The labeling of the boxes and sterile pouches did not match the contents. | Class II | Conformis, Inc. |
| Jan 4, 2019 | King LTS-D Kit Size 1, Model Number KLTSD431 | Size 0 products were incorrectly packaged and labeled as a size 1 products. | Class II | King Systems Corp. dba Ambu, Inc. |
| Dec 26, 2018 | Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G... | On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica... | Class III | Luminex Corporation |
| Dec 21, 2018 | Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... | Class II | Zimmer Biomet, Inc. |
| Dec 21, 2018 | DigitalDiagnost C50, Stationary X-ray System | During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing... | Class II | Philips Healthcare |
| Dec 21, 2018 | Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 | Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... | Class II | Zimmer Biomet, Inc. |
| Dec 20, 2018 | Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 | Presence of natural rubber latex is not declared in the label | Class II | Terumo Cardiovascular Systems Corporation |
| Dec 19, 2018 | Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of b... | A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. | Class II | Boston Scientific Corporation |
| Dec 18, 2018 | COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4S... | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ... | Class II | Wilson-Cook Medical Inc. |
| Dec 18, 2018 | COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with ... | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) ... | Class II | Wilson-Cook Medical Inc. |
| Dec 18, 2018 | PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Pr... | The sutures inside the packaging are not the same size or type as indicated on the label. | Class II | Ethicon, Inc. |
| Dec 17, 2018 | DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric ... | Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. | Class II | DeRoyal Industries Inc |
| Dec 14, 2018 | Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter ... | Incorrect (higher) Rated Burst Pressure information printed on label. | Class II | BrosMed Medical Co.,Ltd. |
| Dec 13, 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2... | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ... | Class II | Arrow International Inc |
| Dec 13, 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2... | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ... | Class II | Arrow International Inc |
| Dec 10, 2018 | ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the fo... | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio... | Class II | ProSun International, LLC |
| Dec 10, 2018 | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled a... | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio... | Class II | ProSun International, LLC |
| Dec 7, 2018 | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diamet... | The incorrect outer carton box was used for the product. | Class II | Spectranetics Corporation |
| Dec 4, 2018 | BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LI... | The internal labeling included with these implants may include incorrect part numbers and could r... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
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.