Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 31, 2011 | Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single... | Cutter was longer than was stated on the label | Class II | The Anspach Effort, Inc. |
| Mar 31, 2011 | AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.... | Cutter was longer than was stated on the label | Class II | The Anspach Effort, Inc. |
| Jan 31, 2011 | Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon... | On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilat... | Class II | Cordis Corporation |
| Jan 31, 2011 | Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Ballo... | On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dila... | Class II | Cordis Corporation |
| Nov 22, 2010 | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level ... | Incorrect control range in product labeling | Class III | Medtest Holdings, Inc. |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... | Class II | Medtronic Xomed, Inc. |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... | Class II | Medtronic Xomed, Inc. |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... | Class II | Medtronic Xomed, Inc. |
| Aug 11, 2010 | Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold th... | This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli... | Class II | Breg Inc, An Orthofix Company |
| 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. |
| Apr 28, 2010 | AperFix Femoral Implant Coring Removal Drill, labeled as the following: ... | A review of product complaints in 2010 identified a trend for the Coring Removal Drill of prematu... | Class II | Cayenne Medical Inc. |
| Jul 21, 2009 | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(H... | Individual vials of calibrator and standard were mislabeled; specifically the units on the vial l... | Class III | Medtest Holdings, Inc. |
| Jun 4, 2009 | Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modu... | Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Scre... | Class II | Atlas Spine, Inc. |
| May 28, 2009 | Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage T... | Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices becaus... | Class II | Alere San Diego, Inc. |
| Apr 6, 2009 | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring ... | The firm is initiating this recall because the implied or stated indications in their labeling as... | Class II | Stellate Systems |
| Mar 4, 2009 | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014... | Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the ... | Class II | Invatec Llc |
| Jul 16, 2008 | Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessor... | Distribution of a product that did not meet specifications. (labeling error) | Class II | SRI Surgical |
| Jan 18, 2007 | Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocol... | Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labele... | Class II | Beevers Manufacturing & Supply, 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.