Browse Device Recalls
40 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 40 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 40 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2021 | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... | Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O30300... | Class III | Medline Industries Inc |
| Jan 7, 2020 | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... | There is potential for the sterile wrap to become loose while in transit and compromise the steri... | Class II | Medline Industries Inc |
| May 30, 2019 | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into variou... | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. | Class II | Medline Industries, Inc. |
| Jan 12, 2018 | BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile... | One of the cases of product might not have been sterilized. | Class II | Medline Industries, Inc. |
| Apr 12, 2017 | LASER CDS | Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep"... | Class II | Medline Industries, Inc. |
| 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 |
| 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 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. |
| 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 |
| 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. |
| 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***Extended PTFE Coated Needle 4.0" (... | 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***Standard PTFE Coated Needle 2.75" ... | 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.