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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Dec 23, 2020 At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205... Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pre... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Premium At Home Pro Series Insemination Kit (SKU 644042787927) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 23350000... The instruments may become cold welded together when the drill is inserted through the Soft Tissu... Class II Biomet, Inc.
Dec 23, 2020 Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 18, 2020 Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift wi... Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, lea... Class I Hill-Rom, Inc.
Dec 17, 2020 A calculator/data processing module for clinical use is an electronic device ... A software error results in the unintentional removal of the serum-indices flag that would otherw... Class II Roche Diagnostics Operations, Inc.
Dec 16, 2020 Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Nu... A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that c... Class II Cook Medical Llc
Dec 15, 2020 Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056... Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could l... Class II DePuy Orthopaedics, Inc.
Dec 8, 2020 Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas ... Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ... Class II Roche Diagnostics Operations, Inc.
Dec 8, 2020 Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e... Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ... Class II Roche Diagnostics Operations, Inc.
Dec 2, 2020 CoaguChek XS Prof (Professional) Meters- IVD professional healthcare provider... Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ... Class II Roche Diagnostics Operations, Inc.
Dec 2, 2020 CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting t... Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ... Class II Roche Diagnostics Operations, Inc.
Dec 1, 2020 Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: int... Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure Class II Biomet, Inc.
Nov 25, 2020 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 1035... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Pro... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product U... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-R... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook 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.