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.

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DateProductReasonClassFirm
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.