Browse Device Recalls
25 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 25 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 25 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium He... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004 | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502 | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparin... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503 | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fl... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings ... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diamet... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| May 5, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassiu... | All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to ... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
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.