Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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Date	Product	Reason	Class	Firm
Oct 21, 2015	LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indi...	Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead...	Class II	LeMaitre Vascular, Inc.
Oct 21, 2015	CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12...	Sterility of the product cannot be assured.	Class II	Civco Medical Instruments Co. Inc.
Oct 20, 2015	iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Pane...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of th...	SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the f...	Class II	Pega Medical Inc.
Oct 20, 2015	DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of A...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abus...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. T...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Pan...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pn...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI30...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Ab...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs ...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300)...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs ...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP),...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT...	The devices were packaged and laser marked anatomically incorrect. The Left plates were laser mar...	Class II	Smith & Nephew, Inc.
Oct 20, 2015	CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. ...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests ar...	Ameditech is recalling drug abuse tests because they have shown reduced reactivity.	Class II	Ameditech Inc
Oct 20, 2015	Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGH...	The devices were packaged and laser marked anatomically incorrect. The Left plates were laser mar...	Class II	Smith & Nephew, Inc.
Oct 19, 2015	FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Siz...	Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of th...	Class II	Bard Peripheral Vascular Inc
Oct 19, 2015	The system provides the ability to transmit patient data files for storage, v...	Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze	Class II	Invivo Corporation
Oct 19, 2015	Synthes Application Instrument for Sternal ZIPFIX. Indications for use incl...	Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on Au...	Class II	Synthes (USA) Products LLC
Oct 16, 2015	Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling...	Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-steri...	Class II	Utah Medical Products, Inc
Oct 16, 2015	ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ...	Possibility that the catheter peel-away component hub tabs may prematurely detach when the pract...	Class II	Arrow International Inc
Oct 16, 2015	Monaco - Radiation Treatment Planning used to make treatment plans for patie...	Unintended update of Dose and MU and Incorrect Assignment of Bolus.	Class II	Elekta, Inc.
Oct 15, 2015	DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA...	Complaint investigation concluded that although product quality requirements stated in the instr...	Class II	Euro Diagnostica AB
Oct 15, 2015	DR Systems Unity PACS software, now known as Merge Unity PACS software.	The software fails to associate to the correct MG image if there are two images for the same view.	Class II	Merge Healthcare, Inc.
Oct 15, 2015	Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmed...	Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the U...	Class II	Stryker Howmedica Osteonics Corp.
Oct 14, 2015	Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis follo...	The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to re...	Class II	TZ Medical Inc.
Oct 14, 2015	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Styl...	Incorrectly packaged with a 90 degree bend at the distal tip	Class II	Covidien LLC
Oct 14, 2015	Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M,...	The following MRx software issue has been identified: MRx model M3535A with software version F.03...	Class II	Philips Electronics North America Corporation
Oct 14, 2015	HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per bo...	DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorr...	Class II	DeRoyal Industries Inc
Oct 14, 2015	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Styl...	Incorrectly packaged with a 90 degree bend at the distal tip	Class II	Covidien LLC
Oct 14, 2015	SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitr...	During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that s...	Class II	TZ Medical Inc.
Oct 14, 2015	Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft a...	Incorrectly packaged with a 90 degree bend at the distal tip	Class II	Covidien LLC
Oct 14, 2015	Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 ...	Incorrectly packaged with a 90 degree bend at the distal tip	Class II	Covidien LLC
Oct 14, 2015	SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades ...	It was reported that packaging was not properly sealed.	Class II	Stryker Sustainability Solutions
Oct 14, 2015	Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm)...	Incorrectly packaged with a 90 degree bend at the distal tip	Class II	Covidien LLC
Oct 14, 2015	Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access p...	The defective component can cause gas leakage through the device. This can result in loss of pne...	Class II	Teleflex Medical
Oct 13, 2015	Two-stage and three-stage I.V. poles are shipped as an optional accessory to ...	It was identified by a customer complaint that some I.V. poles were retracting/lowering from an ...	Class II	Stryker Medical Division of Stryker Corporation
Oct 13, 2015	NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plasti...	The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause th...	Class II	Ceterix Orthopedics, Inc.
Oct 13, 2015	Access CEA Assay, Part No. 33200. For the quantitative determination of Carc...	Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.	Class II	Beckman Coulter Inc.
Oct 13, 2015	Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7...	A component on the systems power board can fail in a manner which can cause the ventilator to shu...	Class I	Event Medical LTD
Oct 9, 2015	SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medic...	CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.	Class II	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.