Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 12, 2017 | OTTO BOCK Kenevo knee joints Model 3C60 | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability tes... | Class II | Otto Bock Healthcare Product |
| Sep 12, 2017 | OTTO BOCK Kenevo knee joints Model 3C60=ST | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability tes... | Class II | Otto Bock Healthcare Product |
| Sep 1, 2017 | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500... | The recommended storage temperature on the label is incorrect. | Class II | Aaren Scientific Inc. |
| Sep 1, 2017 | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (com... | The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister la... | Class III | CooperVision Inc. |
| Aug 31, 2017 | Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulde... | Potentially mislabeled. | Class II | Exactech, Inc. |
| Aug 31, 2017 | Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder... | Potentially mislabeled. | Class II | Exactech, Inc. |
| Aug 30, 2017 | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the... | The device had an incorrect printed calibration value on the calibration certificate. | Class II | Carl Zeiss Meditec AG |
| Aug 25, 2017 | Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants ... | The recalled units are mislabeled with an incorrect expiration date. The expiration date printed ... | Class II | Keystone Dental Inc |
| Aug 25, 2017 | AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.... | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... | Class II | Zimmer Biomet, Inc. |
| Aug 25, 2017 | AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. ... | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... | Class II | Zimmer Biomet, Inc. |
| Aug 25, 2017 | G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arth... | The affected products are labeled and etched as F-44 mm liners; however, the physical products co... | Class II | Zimmer Biomet, Inc. |
| Aug 23, 2017 | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034... | The high control for the kit is recovering low and may be out of range for assigned values. | Class II | The Binding Site Group, Ltd. |
| Aug 14, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Aug 10, 2017 | NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega... | The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the in... | Class II | Aesculap Implant Systems LLC |
| Aug 10, 2017 | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is... | Incorrect source step size may occur in the software plans | Class II | Nucletron BV |
| Aug 9, 2017 | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size ... | Medtronic implemented a final design change intended to address the motor stall due to corrosion ... | Class II | Medtronic Neuromodulation |
| 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 7, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Aug 4, 2017 | Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, ... | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Ultradent Products, Inc. |
| Aug 4, 2017 | Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, ... | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Ultradent Products, Inc. |
| Aug 4, 2017 | Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, ... | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Ultradent Products, Inc. |
| Aug 4, 2017 | Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, ... | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Ultradent Products, Inc. |
| Aug 4, 2017 | Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ... | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Ultradent Products, Inc. |
| Aug 1, 2017 | Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a... | The products being recalled exceeded the weight previously tested leading to a possibility of dam... | Class II | Zimmer Biomet, Inc. |
| Jul 31, 2017 | 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Ro... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blo... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clav... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotat... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, R... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, S... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ ... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand P... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotatin... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile ... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Rem... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gan... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, 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.