Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 18, 2022 | Medline CISION Sterile Blades. Labeled as follows with corresponding Item Nu... | Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTIO... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. S... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: IM NAIL | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR B... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b.... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CD... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: LS MS PACK | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as CRANI, 2 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HA... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. B... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOT... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 C... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS C... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATIO... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 8, 2022 | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | Class II | Corin Ltd |
| Nov 8, 2022 | Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | Class II | Corin Ltd |
| Nov 7, 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... | Class III | R & D Systems, Inc. |
| Oct 27, 2022 | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020,... | Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for ste... | Class II | Southmedic, Inc. |
| Oct 27, 2022 | CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell relate... | Device is mislabeled. The package insert for this ASR device contains a chromomap - an image show... | Class II | Cytocell Ltd. |
| Oct 21, 2022 | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, ... | Sinus Implant product label displays incorrect product information including: "Straight Delivery ... | Class II | Intersect ENT, Inc. |
| Oct 18, 2022 | Hill-Rom Progressa Bed System | The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the... | Class II | Baxter Healthcare Corporation |
| Oct 14, 2022 | GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Sin... | Procedure Instruments with erroneous unit carton labels. | Class II | Sonendo Inc |
| Oct 14, 2022 | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | Procedure Instruments with erroneous unit carton labels. | Class II | Sonendo 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.