Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2013 | MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Me... | Drug flow rates exceeding programmed flow rates. | Class I | Codman & Shurtleff, Inc. |
| Aug 12, 2013 | Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed i... | A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... | Class II | MicroAire Surgical Instruments, LLC |
| Aug 12, 2013 | T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile ... | One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 12, 2013 | Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introd... | Due to a labeling error related to the conversion of the inner diameter of the catheter from inch... | Class II | Cordis Corporation |
| Aug 12, 2013 | Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change K... | Microbore tubing disconnecting from male luers on the extension sets. | Class II | Churchill Medical Systems, Inc. |
| Aug 12, 2013 | Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for th... | Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration ... | Class II | Abbott Laboratories, Inc |
| Aug 12, 2013 | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is ... | Microbore tubing disconnecting from male luers on the extension sets. | Class II | Churchill Medical Systems, Inc. |
| Aug 12, 2013 | DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoy... | One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable p... | Class II | DeRoyal Industries Inc |
| Aug 12, 2013 | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a steril... | A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... | Class II | MicroAire Surgical Instruments, LLC |
| Aug 12, 2013 | ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN... | Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120... | Class II | Siemens Healthcare Diagnostics |
| Aug 9, 2013 | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen... | The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia... | Class III | Copan Italia |
| Aug 9, 2013 | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTI... | OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could pe... | Class II | OPTI Medical Systems, Inc |
| Aug 9, 2013 | Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagno... | During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and... | Class II | Sonogage Inc |
| Aug 9, 2013 | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INST... | The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Brid... | Class II | Varian Medical Systems, Inc. |
| Aug 8, 2013 | Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-... | The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for si... | Class II | Philips Healthcare Inc. |
| Aug 8, 2013 | Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, S... | The manufacturing and expiration dates are not printed on the blister pack label. | Class II | Teleflex Medical |
| Aug 7, 2013 | Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1... | There is a potential for water to collect in the vent pipe elbow in the magnet venting system. W... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 7, 2013 | GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be u... | GE has recently become aware of a potential safety issue due to the incorrect calculation of the ... | Class II | GE Healthcare, LLC |
| Aug 7, 2013 | Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syrin... | Manufacturer made a change in the production process that resulted in a change in final gel weigh... | Class I | Enhancement Medical, LLC |
| Aug 7, 2013 | E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. ... | Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode St... | Class II | Megadyne Medical Products, Inc. |
| Aug 6, 2013 | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (b... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue;... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 7220077... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biod... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 7220077... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Num... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; P... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; P... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Nu... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Numbe... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 5, 2013 | Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended ... | The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that... | Class II | Medicel Ag |
| Aug 5, 2013 | Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic im... | The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... | Class II | Toshiba American Medical Systems Inc |
| Aug 5, 2013 | Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic... | The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... | Class II | Toshiba American Medical Systems Inc |
| Aug 5, 2013 | 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and... | 3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast P... | Class II | 3M Company - Health Care Business |
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.