Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 6, 2020 | 11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Cl... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per cas... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit p... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(0... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoC... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Dro... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Ye... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotatin... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 p... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Re... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Val... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Ro... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cl... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 Micro... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave R... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/R... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn,... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave C... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Base... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 un... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 u... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Rem... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Cla... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 1, 2020 | REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClav... | Incorrect filter assemblies in IV administration set. | Class II | ICU Medical, Inc. |
| Jun 30, 2020 | Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained ... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide traine... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8000 modular infusion pump and monitoring system | If one or more screws or washers are loose or missing causing the battery not to be properly secu... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris PCA Module Model 8120, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to ... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and mon... | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Pump Module Model 8100 | Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Pump Module Model 8100, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trai... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8015. modular infusion pump and monitoring system | If one or more screws or washers are loose or missing causing the battery not to be properly secu... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, 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.