Browse Device Recalls
14 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 14 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 14 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 13, 2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D... | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient resul... | Class II | Siemens Healthcare Diagnostics Products Ltd. |
| Jul 13, 2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY... | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient resul... | Class II | Siemens Healthcare Diagnostics Products Ltd. |
| Nov 22, 2016 | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) T... | Siemens is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Pa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 18, 2016 | IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay... | Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 18, 2016 | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Cat... | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number ... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 20, 2013 | IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, S... | Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha... | Class II | Siemens Healthcare Diagnostics |
| Dec 20, 2013 | IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380... | Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the... | Class II | Siemens Healthcare Diagnostics |
| Dec 20, 2013 | IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SM... | Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater tha... | Class II | Siemens Healthcare Diagnostics |
| Dec 20, 2013 | IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD -... | Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the... | Class II | Siemens Healthcare Diagnostics |
| Nov 6, 2013 | IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ... | potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000... | Class II | Siemens Healthcare Diagnostics |
| Aug 27, 2013 | T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material N... | Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ... | Class II | Siemens Healthcare Diagnostics |
| Aug 27, 2013 | T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 1... | Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ... | Class II | Siemens Healthcare Diagnostics |
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.