Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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Date	Product	Reason	Class	Firm
Aug 21, 2019	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a...	Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)...	Class II	Boston Scientific Corporation
Aug 21, 2019	BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product U...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM000009...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331...	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ...	Class II	Zimmer Biomet, Inc.
Aug 21, 2019	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.	Reports received of the device fracturing during insertion.	Class II	CTL Medical Corporation
Aug 20, 2019	TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828	Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie...	Class II	Quality Electrodynamics LLC
Aug 20, 2019	TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524	Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie...	Class II	Quality Electrodynamics LLC
Aug 20, 2019	FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IV...	The firm has identified that an incorrect instruction for use (IFU) revision was included in the ...	Class III	Biofire Defense
Aug 20, 2019	20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product...	Mislabeled needle lengths	Class II	Repro-Med Systems, Inc.
Aug 20, 2019	TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453	Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie...	Class II	Quality Electrodynamics LLC
Aug 20, 2019	TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460	Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie...	Class II	Quality Electrodynamics LLC
Aug 20, 2019	TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525	Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie...	Class II	Quality Electrodynamics LLC
Aug 20, 2019	TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464	Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie...	Class II	Quality Electrodynamics LLC
Aug 20, 2019	TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829	Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie...	Class II	Quality Electrodynamics LLC
Aug 19, 2019	BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when us...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatr...	Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays i...	Class II	OrthoPediatrics Corp
Aug 19, 2019	TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - ...	Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com...	Class II	Howmedica Osteonics Corp.
Aug 19, 2019	BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when us...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - P...	Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com...	Class II	Howmedica Osteonics Corp.
Aug 19, 2019	BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 6591...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing P...	Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a de...	Class II	OrthoPediatrics Corp
Aug 19, 2019	BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when us...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical ...	Discrepancy between the correct expiration dates on the individual pouches inside the boxes and i...	Class III	CooperSurgical, Inc.
Aug 19, 2019	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when us...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic su...	Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing...	Class II	Intuitive Surgical, Inc.
Aug 19, 2019	TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal A...	Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com...	Class II	Howmedica Osteonics Corp.
Aug 19, 2019	Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pe...	Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays i...	Class II	OrthoPediatrics Corp
Aug 19, 2019	BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when us...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - ...	Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com...	Class II	Howmedica Osteonics Corp.
Aug 19, 2019	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when us...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when u...	Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (...	Class II	Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019	RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (1...	It has been determined that some units of catheters were not tightly connected to the thumb port....	Class II	RESPIRATORY THERAPEUTICS GROUP LLC
Aug 16, 2019	REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 99999...	The femoral impactors have a higher than normal risk of the arm breaking. During impaction the ti...	Class II	Enztec Limited
Aug 16, 2019	Irrisept Wound Debridement and Cleansing System. 12 units per case.	Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.	Class II	IrriMAX Corporation
Aug 15, 2019	Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200...	It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ...	Class II	Beckman Coulter Inc
Aug 15, 2019	XP-XP Tibial Tray - Interlok 91mm Item # 195761	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	Vanguard XP Tibial Tray 83 mm Item # 195253	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	XP-CR Tibial Tray - Interlok 69mm Item # 195272	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	XP-CR Tibial Tray - Interlok 67mm Item # 195271	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	XP-XP Tibial Tray - Interlok 87 mm Item # 195760	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	Vanguard XP Tibial Tray 87 mm Item # 195254	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Gra...	Limited access to flow settings as a result of the control knob having been rotated beyond its f...	Class II	Western / Scott Fetzer Company
Aug 15, 2019	XP- CR Tibial Tray- Interlok 59mm Item # 195268	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	XP-XP Tibial Tray - Interlok 71 mm Item # 195755	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	Vanguard XP Tibial Tray 71 mm Item # 195249	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	XP-XP Tibial Tray - Interlok 63 mm Item # 195751	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Gra...	Limited access to flow settings as a result of the control knob having been rotated beyond its f...	Class II	Western / Scott Fetzer Company
Aug 15, 2019	XP-CR Tibial Tray - Interlok 79 mm Item # 195276	The locking bar not fully engaging	Class II	Zimmer Biomet, Inc.
Aug 15, 2019	XP-CR Tibial Tray - Interlok 73mm Item # 195274	The locking bar not fully engaging	Class II	Zimmer Biomet, 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.