Browse Device Recalls
3,037 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,037 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 3,037 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 20, 2023 | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 12, 2023 | Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 400... | The product contains an expired diluent vial. If the impacted product is used, the sterility of t... | Class II | TELEFLEX LLC |
| Apr 6, 2023 | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for... | Inadvertently released for distibution without sterility assurance. | Class II | Cardinal Health 200, LLC |
| Mar 28, 2023 | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 28, 2023 | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 10, 2023 | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175... | Sterility; Steril surgical procedure packs contain incomplete seals. | Class II | Alcon Research, LLC |
| Feb 13, 2023 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ... | Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. ... | Class II | Maquet Medical Systems USA |
| Jan 30, 2023 | CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog ... | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of th... | Class II | Carefusion 2200 Inc |
| Dec 20, 2022 | CustomEyes kits | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 20, 2022 | Ultracell Wick with 80cc Collection Bag, 20/box | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 15, 2022 | HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Tech... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs P... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy ... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | PICC KIT, 10/CS, ACCESS MEDICAL LABEL | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufacture... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Henry Shein GLOVES, packaged in the following sizes and descriptions: a. G... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Pac... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosp... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vi... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and ca... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per ba... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care T... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Heal... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Dec 15, 2022 | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by ... | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... | Class II | Stradis Healthcare |
| Nov 30, 2022 | Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente... | Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility... | Class II | Beaver Visitec International, Inc. |
| Nov 2, 2022 | HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, BREAST PACK, Item No.570-2397 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery ... | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, GYN PACK, Item No.570-2625 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, ENT PACK, Item No.570-2718 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
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.