Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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) |
| Dec 4, 2018 | BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 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) |
| Dec 3, 2018 | iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121... | The kits were prepared with incorrect patient ID labels and may contain incorrect components. | Class II | Conformis, Inc. |
| Dec 1, 2018 | MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque St... | The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feedin... | Class II | Canadian Hospital Specialties |
| Nov 28, 2018 | ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platfor... | The peek part was loose on the titanium base of the device which could result in it falling into ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 28, 2018 | ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platfor... | The peek part was loose on the titanium base of the device which could result in it falling into ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 21, 2018 | Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits ... | Potential that product has not reached complete sterilization, | Class II | American Contract Systems, Inc. |
| Nov 20, 2018 | Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product... | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... | Class II | Zimmer Biomet, Inc. |
| Nov 20, 2018 | Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Produ... | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... | Class II | Zimmer Biomet, Inc. |
| Nov 16, 2018 | Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir... | This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... | Class II | LivaNova USA Inc |
| Nov 16, 2018 | Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi... | This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... | Class II | LivaNova USA Inc |
| Nov 16, 2018 | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... | Lead impedance values reported by the affected VNS generator will be higher compared to those rep... | Class II | LivaNova USA Inc |
| Nov 15, 2018 | Revanesse Versa, PN40081 | Labeling error. The product is labeled with an 18 month expiration date, however the product is a... | Class II | Prollenium Medical Technologies Inc. |
| Nov 13, 2018 | Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE ... | Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter pa... | Class II | Stryker Neurovascular |
| Nov 9, 2018 | TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter ... | A limited number of lenses may be mislabeled with the incorrect diopter power. | Class II | Tekia, Inc. |
| Nov 2, 2018 | CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08,... | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket d... | Class II | CIVCO Medical Instruments Co., Inc. |
| Nov 2, 2018 | CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket wit... | Class II | CIVCO Medical Instruments Co., Inc. | |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile ligh... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2018 | Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light ... | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... | Class II | Cardinal Health 200, 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.