Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 6, 2020 | 12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 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 | Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Produc... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoCla... | 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 w/Baseplate, Rotating Luer; 1 u... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use... | The lidstock states the incorrect expiration date for the product. This issue could result in use... | Class II | Arrow International Inc |
| Jul 6, 2020 | 8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Fil... | 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 | 135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way S... | 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 (01)... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 5... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 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 | 8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit pe... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product ... | Breaking at the point of a welded joint | Class II | TELEFLEX MEDICAL INC |
| Jul 6, 2020 | 11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 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 | 8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 un... | 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) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/M... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoCla... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, C... | 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 | Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in t... | The lidstock states the incorrect expiration date for the product. This issue could result in use... | Class II | Arrow International Inc |
| Jul 6, 2020 | 58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, Mic... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire ca... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | 7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotati... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave ST... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoCl... | 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 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock... | 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 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1... | 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 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit pe... | 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) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to prov... | Suspect poor weld on back KD bar. | Class II | Golden Technologies, Inc. |
| Jul 6, 2020 | 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, ... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per p... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| Jul 6, 2020 | 5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1... | Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... | Class II | ICU Medical, Inc. |
| 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 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
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.