Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2017 | PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (L... | 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 | 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 28, 2017 | Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merli... | 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 | PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These... | 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 | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models E... | 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 | PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devic... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 24, 2017 | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter ... | Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibra... | Class II | Beckman Coulter Inc. |
| Aug 21, 2017 | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended f... | Beckman Coulter has identified that an incorrect setting using a proprietary software configurati... | Class II | Beckman Coulter Inc. |
| Aug 9, 2017 | Alaris Pump Module model 8100 manufactured between November 2011 and March 20... | The recalling firm has received reports of increased or decreased flows that have occurred in cer... | Class II | CareFusion 303, Inc. |
| Aug 7, 2017 | MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref G... | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. | Class II | Microvention, Inc. |
| Aug 3, 2017 | Power Processor 1K Stockyard. The Power Processor performs all pre-analyti... | Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can ini... | Class II | Beckman Coulter 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. |
| Jul 31, 2017 | 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 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 | 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way ... | 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 | 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 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 | 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Cle... | 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 | 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating... | 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 | 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w... | 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 | 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClav... | 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 | 107" (272 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 | 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port,... | 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 Admin Set w/200 Micron Filter, Hand Pump, ... | 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 | 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, 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. |
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.