Browse Device Recalls
1,532 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,532 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 1,532 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 8, 2014 | Hudson burrs are bone cutting and drilling instruments that are used without ... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | CVB distraction screws are bone cutting and drilling instruments that are use... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | An endometrial suction curette is a device used to remove material from the u... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A circumcision clamp is an instrument used to compress the foreskin of the pe... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A zipser clamp is an instrument used to compress reduce blood flow to the pen... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Mar 20, 2014 | Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrap... | This lot did not go through the correct sterilization procedures. This product may potentially be... | Class II | Medline Industries Inc |
| Nov 4, 2013 | Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap;... | There is a potential that the specified mucus specimen traps are not sterile. Use of the affected... | Class II | Medline Industries Inc |
| Aug 14, 2013 | ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industri... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries,... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline I... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries,... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., M... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Aug 14, 2013 | HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Indus... | Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... | Class I | Medline Industries, Inc. |
| Apr 30, 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... | Class II | American Optisurgical Inc |
| Nov 8, 2012 | Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... | The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... | Class II | Medline Industries Inc |
| Sep 20, 2012 | Medline Total Knee CDS; a single patient prescription procedure pack and disp... | The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pa... | Class II | Medline Industries Inc |
| 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.