Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

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Date	Product	Reason	Class	Firm
Sep 14, 2012	Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular Sy...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, Inc.
Sep 14, 2012	Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4...	InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical ...	Class II	Hologic, Inc.
Sep 14, 2012	Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is ind...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, Inc.
Sep 14, 2012	Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System ...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, Inc.
Sep 14, 2012	Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is ...	Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the po...	Class II	Zimmer, Inc.
Sep 14, 2012	Merit Medical's Custom Procedural Tray or Kits K12T-03162B &amp; K12T-02...	Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because o...	Class II	Merit Medical Systems, Inc.
Sep 14, 2012	AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identific...	GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomona...	Class II	Advandx Inc
Sep 14, 2012	ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot N...	This recall was initiated because some customers were experiencing an alarm during Creatinine cal...	Class III	Horiba Instruments, Inc dba Horiba Medical
Sep 14, 2012	Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Leve...	HORIBA Medical Irvine Technical Support received reports from some customers that have experience...	Class III	Horiba Instruments, Inc dba Horiba Medical
Sep 14, 2012	Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1an...	Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may b...	Class II	Hologic, Inc.
Sep 13, 2012	Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary...	A complaint received from sales representative that a replenishment instrument was too short. Upo...	Class II	OrthoPediatrics Corp
Sep 13, 2012	3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas S...	3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilize...	Class II	3M Company - Health Care Business
Sep 13, 2012	CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are...	Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit...	Class II	Zimmer, Inc.
Sep 13, 2012	HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to...	Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions tha...	Class I	Heartsine Technologies, Limited
Sep 13, 2012	CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are pri...	Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit...	Class II	Zimmer, Inc.
Sep 13, 2012	CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CP...	Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit...	Class II	Zimmer, Inc.
Sep 12, 2012	The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is inten...	MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software ...	Class II	Mako Surgical Corporation
Sep 12, 2012	Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic R...	When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as i...	Class II	Siemens Medical Solutions USA, Inc
Sep 12, 2012	Philips Digital Diagnost with patient carriage Model: 712050 with serial nu...	Hook does not securely hold the footplate in vertical position, causing the footplate to disengag...	Class II	Philips Healthcare Inc.
Sep 11, 2012	Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P...	Philips was notified that when performing post processing with the Brilliance Workspace Portal pl...	Class II	Philips Medical Systems (Cleveland) Inc
Sep 11, 2012	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat...	HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with ...	Class II	Philips Healthcare Inc.
Sep 11, 2012	Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) ...	BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 10, 2012	Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Te...	Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Te...	Class II	Terumo Cardiovascular Systems Corporation
Sep 10, 2012	STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERIL...	Some set screw thread profiles were found not to be within specifications.	Class II	PIONEER SURGICAL TECHNOLOGY, INC.
Sep 10, 2012	Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to...	The potential exists for the wheel to rotate freely despite engagement of hub brake.	Class II	Invacare Corporation
Sep 7, 2012	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve...	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ...	Class I	Baxter Healthcare Corp.
Sep 7, 2012	Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; ...	Firm initiated an update to Directions for Use necessitating replacement of previously distribute...	Class II	Instrumentation Industries Inc
Sep 7, 2012	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear...	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ...	Class I	Baxter Healthcare Corp.
Sep 7, 2012	Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part ...	This action is being initiated following a detailed investigation in response to reported complai...	Class II	Synthes USA HQ, Inc.
Sep 7, 2012	Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bo...	This action is being initiated following a detailed investigation in response to reported complai...	Class II	Synthes USA HQ, Inc.
Sep 7, 2012	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Bur...	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ...	Class I	Baxter Healthcare Corp.
Sep 7, 2012	Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped ...	Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "Th...	Class II	Optovue Inc.
Sep 7, 2012	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The p...	The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (...	Class II	C.R. Bard, Inc., Urological Division
Sep 7, 2012	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear...	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ...	Class I	Baxter Healthcare Corp.
Sep 7, 2012	Cemented Tibial Drill Product Usage: The cemented tibial drill is used to...	Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Kn...	Class II	Zimmer, Inc.
Sep 6, 2012	SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRA...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK ...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anc...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK ...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK ...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distri...	During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardia...	Class II	Greatbatch Medical
Sep 6, 2012	SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 22...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anc...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRA...	Fracture of SPIRALOK Anchors post op, requiring patient revision	Class II	DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012	Sterile, single-use, disposable electrosurgical electrode holder. It connect...	The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. ...	Class III	Gynex 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.