Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 4, 2017 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... | A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... | Class II | Beckman Coulter Inc. |
| Nov 29, 2017 | BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 92065... | Some printing modes on the devices may not function properly (tabular data printing, real-time co... | Class II | Smiths Medical ASD Inc. |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Nov 10, 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tub... | Particulate found on the Curlin spike. | Class II | Zevex Incorporated (dba Moog Medical Medical De... |
| Oct 30, 2017 | Plum 360 Infusion System, List number 30010. | (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" sta... | Class II | ICU Medical Inc |
| Oct 30, 2017 | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Nu... | Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggybac... | Class II | ICU Medical Inc |
| Oct 19, 2017 | NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | Datascope Corporation |
| Oct 16, 2017 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: ... | For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices... | Class II | Fukuda Denshi Co., Ltd. |
| Oct 2, 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor,... | Pre-procedural issues related to software defects | Class II | Edwards Lifesciences, LLC |
| Sep 15, 2017 | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has b... | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or i... | Class II | HILL-ROM MANUFACTURING, INC. |
| Sep 13, 2017 | Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal... | Potential for failure of the device safety interlock. The safety interlock prevents an empty sing... | Class II | Covidien LLC |
| Aug 31, 2017 | SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 ... | ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metal... | Class II | ICU Medical, Inc. |
| Aug 28, 2017 | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, P... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Acce... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| 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 1, 2017 | Presource(R) Kits (custom surgical/procedural kits): The standard and custom... | The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... | Class II | Cardinal Health 200, LLC |
| 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. |
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.