Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear

Date	Product	Reason	Class	Firm
Oct 20, 2014	Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, I...	A typographical error regarding the expiration date was identified in the control module instruct...	Class III	Siemens Healthcare Diagnostics, Inc.
Oct 20, 2014	Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta P...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are...	Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the s...	Class II	Radiometer America Inc
Oct 20, 2014	Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pf...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT P...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P090800...	PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f...	Class II	Pfm Medical Inc
Oct 20, 2014	Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EI...	A gel-like substance was found in kit component, sample diluent , that could potentially compromi...	Class II	Diamedix Corporation
Oct 20, 2014	Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA...	A gel-like substance was found in kit component, sample diluent , that could potentially compromi...	Class II	Diamedix Corporation
Oct 19, 2014	ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D13...	The recall was initiated because Biosense Webster is providing additional labeling for the safe a...	Class II	Biosense Webster, Inc.
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand ...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand ...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 ...	Under new testing protocols for MR Environment safety and compatibility, metal devices are no lon...	Class II	Synthes, Inc.
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand R...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand R...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand ...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL R...	Product was improperly labeled leading to improper storage.	Class II	Mallinckrodt Manufacturing LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand ...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi ...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapi...	An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne...	Class I	Siemens Healthcare Diagnostics, Inc.
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Re...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand ...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid...	Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa...	Class II	Maquet Cardiovascular Us Sales, Llc
Oct 17, 2014	Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Mater...	An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne...	Class I	Siemens Healthcare Diagnostics, Inc.
Oct 17, 2014	Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10...	Recalled product may not provide adequate recovery of Legionella pneumophila when used as directe...	Class II	Remel Inc
Oct 17, 2014	Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethic...	Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expec...	Class II	Ethicon, Inc.
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand ...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Rec...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0...	An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxid...	Class II	INO Therapeutics (dba Ikaria)
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Rec...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 17, 2014	Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand R...	Laser etching on the parts is wider and deeper than the conditions previously validated.	Class II	Biomet Microfixation, LLC
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is...	The box of guides for a specific case arrived intact but contained two (2) femoral guides instead...	Class II	Materialise USA LLC
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	MicroVue Bb Plus EIA is packaged as a kit which contains all reagent componen...	Samples are quantitating incorrectly, with approximately 50% higher concentration values than pre...	Class II	Diagnostic Hybrids Inc
Oct 16, 2014	Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head f...	Report received where the Align Radial Stem fractured.	Class II	Skeletal Dynamics
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 15, 2014	AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS M...	During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ...	Class II	American Medical Systems, Inc.
Oct 15, 2014	AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF...	During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ...	Class II	American Medical Systems, Inc.
Oct 15, 2014	ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in ...	Issuing a device correction because if the pin bushing is over loaded or inverted, there is the p...	Class II	DePuy Orthopaedics, Inc.
Oct 15, 2014	AlignRT- Intended for prescription use. The system is indicated for use duri...	Potential failure of AlignRT to assert interlock.	Class II	Vision Rt Inc
Oct 14, 2014	GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads ...	To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T...	Class II	Zimmer, Inc.
Oct 14, 2014	GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infini...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, St...	St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" H...	Class II	St Jude Medical

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.