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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.

Clear
DateProductReasonClassFirm
Jul 13, 2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate... Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... Class III OraSure Technologies, Inc.
Jul 13, 2020 VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
Jul 10, 2020 Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked... Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... Class II RANDOX LABORATORIES, LTD.
Jul 10, 2020 Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... Class II RANDOX LABORATORIES, LTD.
Jul 9, 2020 Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are si... Potential risk of brush detachment during cleaning. Class II Medline Industries Inc
Jul 9, 2020 Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:008484860... Characterization issue associated with the product. This issue may cause a discrepancy during bo... Class II Mako Surgical Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product U... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Pr... During a procedure, when images were acquired, and these images were transferred to PACS /image a... Class II Canon Medical System, USA, INC.
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus a... The plastic housing on the device may fracture Class II New Wave Endo-Surgical, Corp.
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 6, 2020 128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4... 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 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit ... 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 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Rem... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifol... 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 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.... 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: 004550004 GTIN: 14026704663085 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX 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
Jul 6, 2020 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, Na... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)108406... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave M... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock... 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: 004551002 GTIN: 14026704663115 (each) - Produc... Breaking at the point of a welded joint Class II TELEFLEX MEDICAL INC
Jul 6, 2020 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Cla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UD... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, Micro... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clam... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Co... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per po... 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 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, Nano... 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 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, N... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spi... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT Nano... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroCla... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, Nan... 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
Jul 6, 2020 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 un... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Ma... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, 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 APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 po... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... Class II ICU Medical, Inc.
Jul 6, 2020 5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 ... Identification of a potential manufacturing defect on the internal surface of the NanoClave wit... 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.