Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2017 | Liquid Cardiac Control CQ5053 | Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot ... | Class II | Randox Laboratories, Limited |
| Aug 8, 2017 | Alcon Custom Pak | Alcon is initiating a medical device recall, after receiving notification from a supplier of a re... | Class II | Alcon Research, LTD. |
| Aug 8, 2017 | REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and t... | Presence of bacterial endotoxins levels above the acceptable limit | Class II | LifeCell Corporation, A Wholly Owned Subsidiary... |
| Aug 8, 2017 | Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. ... | Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecti... | Class I | Leonhard Lang Medizintechnik GmbH |
| Aug 7, 2017 | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (rei... | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... | Class II | Covidien LLC |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Mat... | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... | Class II | Covidien LLC |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Mat... | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... | Class II | Covidien LLC |
| Aug 7, 2017 | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP M... | May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect... | Class II | Synthes, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (rei... | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... | Class II | Covidien LLC |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For ... | There is a potential for intermittent cracks in the raw material batch used to produce the affect... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (rei... | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... | Class II | Covidien LLC |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM | During the rework process for the April 17, 2017, field action, it was detected that the set scre... | Class II | Zimmer Biomet, Inc. |
| Aug 7, 2017 | Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 F... | There is a potential for intermittent cracks in the raw material batch used to produce the affect... | Class II | Zimmer Biomet, 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.