Browse Device Recalls
1,023 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,023 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 1,023 FDA device recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 20, 2013 | TDHistology/Cytology Classification name: Calculator/data processing modul... | A recall was initiated by Technidata because use of symbols (less than or equal to or greater tha... | Class III | Technidata S.A. |
| Jun 19, 2013 | Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Pro... | Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots | Class III | Beekley Corporation |
| Jun 5, 2013 | 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... | Class III | 3M Company - Health Care Business |
| Jun 3, 2013 | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the ... | As a result of a quality review, labelling content discrepancies were identified between the Inst... | Class III | Integra LifeSciences Corp. |
| May 31, 2013 | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, use... | Electrical power module installed on some in vitro diagnostic instruments does not meet industry ... | Class III | Becton Dickinson & Co. |
| May 28, 2013 | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... | Product labeled with incorrect expiration date. | Class III | Boston Scientific Corporation |
| May 14, 2013 | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in i... | Class III | Optovue, Inc. |
| May 9, 2013 | VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 a... | While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amou... | Class III | Ortho-Clinical Diagnostics |
| May 9, 2013 | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number... | While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant ... | Class III | Ortho-Clinical Diagnostics |
| May 8, 2013 | DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 ... | LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove pa... | Class III | DePuy Orthopaedics, Inc. |
| Apr 15, 2013 | Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Cont... | The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which ori... | Class III | Bio-rad Laboratories, Inc. |
| Apr 12, 2013 | Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID... | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... | Class III | Covidien LLC |
| Apr 12, 2013 | Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... | Class III | Covidien LLC |
| Apr 9, 2013 | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 i... | The incorrect manual may have been packaged with this product. UVB-080 devices may have included ... | Class III | National Biological Corp |
| Apr 8, 2013 | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is... | The incorrect manual may have been packaged with this product. UVB-083 devices may have included... | Class III | National Biological Corp |
| Apr 3, 2013 | VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho... | Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 de... | Class III | Ortho-Clinical Diagnostics |
| Mar 28, 2013 | The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... | 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellit... | Class III | Abbott Molecular |
| Mar 25, 2013 | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(... | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner labe... | Class III | Microbiologics Inc |
| Mar 25, 2013 | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT... | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. | Class III | Remel Inc |
| Mar 22, 2013 | LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. Fi... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Numb... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povi... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid ... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 4, 2013 | Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product... | An internal review of CareFusion's labeling for preoperative skin prep product codes was recently... | Class III | CareFusion 213, LLC |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). I... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Inten... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intend... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for... | Incorrect expiration date | Class III | Sirtex Medical Limited |
| Feb 26, 2013 | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number... | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | Class III | Siemens Healthcare Diagnostics Inc |
| Feb 26, 2013 | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog ... | Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control in... | Class III | Alere San Diego, Inc. |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Nu... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex P... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part N... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 19, 2013 | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003... | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with t... | Class III | Remel Inc |
| Feb 15, 2013 | ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... | Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrec... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Feb 14, 2013 | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 m... | The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags whic... | Class III | Becton Dickinson & Company |
| Feb 8, 2013 | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Ave... | Orthodontic brackets distributed was incorrectly labeled. | Class III | Ultradent Products, Inc. |
| Feb 4, 2013 | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavo... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, Inc. |
| Feb 4, 2013 | Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, ... | Incorrect packaging of regular set and fast set cartridges. | Class III | Ultradent Products, Inc. |
| Jan 24, 2013 | D3000I Advantage Drive System, 230v, surgical instrument motor. Product Us... | The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... | Class III | Linvatec Corp. dba ConMed Linvatec |
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.