Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 4, 2012 | PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... | Damage to the packaging may have compromised the sterility of the device. | Class II | Ethicon Endo-Surgery Inc |
| Sep 25, 2012 | Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Telefl... | Product is being recalled due to the possibility that the tray may contain pinholes, compromising... | Class II | Teleflex Medical |
| Aug 29, 2012 | Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Rem... | Sterility of the product may be compromised. | Class II | Remington Medical Inc. |
| Aug 9, 2012 | Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable... | There is potential for the sterility of the product to be compromised. | Class II | Intuitive Surgical, Inc. |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 9, 2012 | Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: K... | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... | Class II | Omni Life Science |
| Aug 2, 2012 | 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into... | On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it ... | Class III | Steris Corporation |
| Jun 26, 2012 | BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethyle... | BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440... | Class II | Bridgepoint Medical |
| Jun 13, 2012 | seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product ... | Sterility of product may be compromised due to packaging defect | Class II | Genzyme Corporation |
| Jun 13, 2012 | seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Pro... | Sterility of product may be compromised due to packaging defect | Class II | Genzyme Corporation |
| Jun 11, 2012 | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un... | This letter is to notify you that several of our sterile screw products are being voluntarily rec... | Class II | Tedan Surgical Innovations Llc |
| May 9, 2012 | Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA T... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA ... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA ... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA T... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| May 9, 2012 | Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA ... | Potential for the sterility barrier to be compromised. | Class II | Covidien LP |
| Apr 20, 2012 | Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bon... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Optimum Expanse R Grafton is a human bone allograft product containing dem... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Optimum Expanse S Multiple sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft p... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograf... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Jul 1, 2011 | Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction T... | ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 ... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with E... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Ex... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with E... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm ... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Ex... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Ex... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" ... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, 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.