Browse Device Recalls

1,303 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,303 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 1,303 FDA device recalls.

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DateProductReasonClassFirm
Apr 12, 2017 Laparoscopy CDS One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled st... Class II Medline Industries, Inc.
Apr 12, 2017 Cardiac Insulation Pad, OPEN HEART CDS Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation ... Class II Medline Industries, Inc.
Apr 12, 2017 PICC Tray, STERILE, 12 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Apr 12, 2017 Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Dec 14, 2016 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 12, 2016 Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL ... Product was not sterilized. Product was shipped to distribution centers instead of the sterilizat... Class II MEDLINE IND
Nov 23, 2016 Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in ... Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage... Class II Medline Industries Inc
Aug 29, 2016 Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier ... Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 29, 2016 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H... Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 29, 2016 BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit... Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 10, 2016 Rigid Suction Canister 3000 CC and 2000 CC. Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure dur... Class II Medline Industries Inc
May 11, 2016 Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of... There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup... Class II Medline Industries Inc
Aug 3, 2015 Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Wee... The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying ... Class II Medline Industries Inc
Jul 8, 2015 Medline Electrical Clipper with Charging base The Electrical Surgical Cli... Charging base of surgical clippers overheats and smokes. Class II Medline Industries Inc
Sep 8, 2014 Manual trephines are bone cutting and drilling instruments that are used with... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Tonometers are manual devices intended to measure intraocular pressure by app... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 An external vein stripper is an extravascular device used to remove a section... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 Hudson burrs are bone cutting and drilling instruments that are used without ... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 CVB distraction screws are bone cutting and drilling instruments that are use... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 An endometrial suction curette is a device used to remove material from the u... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 A circumcision clamp is an instrument used to compress the foreskin of the pe... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Sep 8, 2014 A zipser clamp is an instrument used to compress reduce blood flow to the pen... The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
Mar 20, 2014 Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrap... This lot did not go through the correct sterilization procedures. This product may potentially be... Class II Medline Industries Inc
Nov 4, 2013 Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap;... There is a potential that the specified mucus specimen traps are not sterile. Use of the affected... Class II Medline Industries Inc
Aug 14, 2013 ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industri... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries,... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline I... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries,... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Indus... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Apr 30, 2013 FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... Class II American Optisurgical Inc
Nov 8, 2012 Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... Class II Medline Industries Inc
Sep 20, 2012 Medline Total Knee CDS; a single patient prescription procedure pack and disp... The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pa... Class II Medline Industries Inc
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 ... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, Inc.
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, Inc.
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with E... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, Inc.
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, Inc.
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Ex... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, Inc.
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with E... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, Inc.
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm ... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, Inc.
Jun 16, 2010 Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Ex... On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... Class II Unimed Surgical Products, 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.