Browse Device Recalls
77 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 77 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 77 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 21, 2026 | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 000... | The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with ... | Class II | Instrumentation Laboratory |
| May 21, 2026 | GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 000554075... | The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots ... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premie... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQ... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407504. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445010 & 00055445011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055415004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No: 00055415011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407510. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407508. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407511. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Model No. 00055430010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415005. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK, Part No. 00055360004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Dec 11, 2025 | The product is used for the evaluation of the intrinsic coagulation pathway, ... | Potential for microbial contamination. | Class II | Instrumentation Laboratory |
| Nov 18, 2025 | HemosIL SynthAFax. Partial Thromboplastin Time Tests. | Recalled lots were manufactured with double the amount of preservative concentration. | Class III | Instrumentation Laboratory |
| Feb 3, 2025 | HemosIL LMW Heparin Controls; Part Number: 0020300200; | Multiple complaints indicating lower than expected quality control (QC) results and in some insta... | Class II | Instrumentation Laboratory |
| Dec 18, 2024 | HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic | Control indicating lower than expected quality control (QC) results and in some instances QC reco... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Jul 13, 2023 | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use... | Sample misidentification could occur under specific conditions and patient management altered b... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis ... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostas... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Feb 3, 2023 | ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the ... | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the AC... | Class II | Instrumentation Laboratory |
| Apr 8, 2022 | HemosIL ReadiPlasTin, Part No. 0020301400 | Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots ... | Class II | Instrumentation Laboratory |
| Feb 22, 2022 | ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP... | Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevate... | Class II | Instrumentation Laboratory |
| Oct 13, 2021 | HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic... | The firm has received customer reports of performance issues with the affected lot, including inc... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic ... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Jul 23, 2019 | ROTEM ex-tem; US Part No: 503-05-US | Prolonged clotting times | Class II | Instrumentation Laboratory Co. |
| Jul 23, 2019 | ROTEM ex-tem Rest of the world part No: 503-05 (ROW) | Prolonged clotting times | Class II | Instrumentation Laboratory Co. |
| Jul 23, 2019 | ROTEM ex-tem Canada Part No: 503-05-CA | Prolonged clotting times | Class II | Instrumentation Laboratory Co. |
| Aug 1, 2018 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - ... | There is a potential for increased imprecision, out of range quality controls and prolonged sampl... | Class II | Instrumentation Laboratory Co. |
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.