Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2014 | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.... | 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may ex... | Class II | Abbott Ireland Diagnostics Division |
| Sep 11, 2014 | The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed... | Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order tha... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 10, 2014 | Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, ... | A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Len... | Class II | Intertrade Imports Inc. |
| Sep 10, 2014 | Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Ad... | A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Len... | Class II | Intertrade Imports Inc. |
| Sep 8, 2014 | VITROS 5600 Integrated System, System Product Code 6802413. For use in the... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou... | Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d... | Class III | Coloplast Manufacturing US, LLC |
| Sep 8, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 4, 2014 | Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile.... | Misbranding: Although the product labeling identifies the catheters as "soft rubber," t... | Class II | Teleflex Medical |
| Sep 2, 2014 | Siemens Ysio Max system The Ysio Max is a radiographic system used in hospit... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detecto... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | Siemens Luminos Agile Max system The Luminos Agile is intended to be used a... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 2, 2014 | Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to... | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 26, 2014 | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm... | The expiration date of the bar code on the envelope label did not match the expiration date next ... | Class II | MAST Biosurgery USA, Inc |
| Aug 22, 2014 | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc,... | These lots of suction canisters and lids have an insufficient seal under low or intermittent suct... | Class II | DeRoyal Industries Inc |
| Aug 11, 2014 | LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group | During label reconciliation a duplicate serial number label was detected to be printed for the LI... | Class III | Datascope Corporation |
| Aug 6, 2014 | B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices... | The primary packaging label (inner pouch label) indicates that the package contents are Catalog I... | Class II | B. Braun Medical, Inc. |
| Aug 4, 2014 | Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is i... | The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM. | Class II | Medical Components, Inc dba MedComp |
| Jul 28, 2014 | Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina M... | A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.... | Class II | Illumina Inc |
| Jul 25, 2014 | Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (... | Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its ca... | Class II | Estill Medical Technologies, Inc |
| Jul 24, 2014 | Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-... | Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a differ... | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 21, 2014 | Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Us... | Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue t... | Class II | Medtronic MiniMed Inc. |
| Jul 18, 2014 | BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ... | The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be ... | Class III | BD Biosciences, Systems & Reagents |
| Jul 15, 2014 | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO c... | The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicate... | Class II | Vascutek, Ltd. |
| Jul 11, 2014 | Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amer... | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Amerx Health Care Corp. |
| Jul 11, 2014 | Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Amerx Health Care Corp. |
| Jul 11, 2014 | Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets... | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Amerx Health Care Corp. |
| Jul 11, 2014 | Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads siz... | Not approved labeling claims (antimicrobial and autolytic debridement) | Class II | Amerx Health Care Corp. |
| Jul 10, 2014 | RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, S... | Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date... | Class III | Teleflex Medical |
| Jul 9, 2014 | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscop... | Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates ... | Class II | Teleflex Medical |
| Jul 9, 2014 | Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat.... | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of rev... | Class II | Integra LifeSciences Corp. |
| Jul 7, 2014 | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm... | Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and c... | Class II | Innovasis, Inc |
| Jul 2, 2014 | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Us... | The device labeling is stamped with 330cc and the device is actually 380cc device. | Class II | Mentor Texas, LP. |
| Jul 2, 2014 | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynare... | "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if... | Class II | Dynarex Corporation |
| Jul 2, 2014 | Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DE... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health Inc. |
| Jul 2, 2014 | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL... | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re... | Class III | Carestream Health Inc. |
| Jul 1, 2014 | Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRU... | The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument ma... | Class II | Biomet, Inc. |
| Jun 25, 2014 | Merci Retriever Intended to restore blood flow in the neurovasculature by ... | Merci Retrievers were shipped to US customers past their expiration date, even though they were l... | Class II | Concentric Medical Inc |
| Jun 25, 2014 | Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentrat... | The case label correctly states partial rebreather but the insert label incorrectly states non-re... | Class II | Salter Labs |
| Jun 25, 2014 | BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abut... | Identifiers on the label are correct but the label has the incorrect color coding. | Class II | Biomet 3i, LLC |
| Jun 23, 2014 | Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000... | Product was held at temperature above the labeled recommended storage temperature | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 23, 2014 | Device Brand Name: Distal Radius Fracture Repair System Device Classificatio... | The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill ... | Class II | Biomet, Inc. |
| Jun 20, 2014 | LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. L... | Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a s... | Class II | Laser Peripherals LLC |
| Jun 13, 2014 | Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable p... | Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4... | Class II | Aesculap, Inc. |
| Jun 12, 2014 | Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREA... | Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 we... | Class II | Zimmer Manufacturing B.V. |
| Jun 11, 2014 | Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aero... | Bottles did not provide positive signals within the time frame of the quality control specificati... | Class II | Remel Inc |
| Jun 9, 2014 | Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal ... | An oversight in the implementation of the design change record resulted in outdated components be... | Class II | Arthrosurface, Inc. |
| Jun 9, 2014 | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufact... | Laser aperture label was not affixed to device prior to shipment in the US. | Class II | Nidek Inc |
| Jun 9, 2014 | 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These device... | Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product con... | Class II | 3M Company - Health Care Business |
| Jun 5, 2014 | Calcium Hydroxide Powder, USP For use in root canal therapy by health care... | One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed... | Class II | Axcentria Pharmaceuticals, LLC |
| Jun 4, 2014 | Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unic... | Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... | Class II | Blue Belt Technologies MN |
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.