Medline Pacer Implant Pack Recall: Incorrect Needle Type in Suture Kits
Medline recalls two sterile surgical kits due to incorrect needle and suture sizes in some packages. Affected units include Pacer Implant Pack REF DYNJ59194A and Thoracotomy Morristown REF DYNJ904220F.
Lower-risk recall
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Contact the company
What happened, in plain English
Medline is recalling two surgical kits because some suture packages contain the wrong needle type, size, or suture diameter/length. This could lead to improper surgical procedures if used without checking the correct specifications. Read more at govinfonow.com/recall/53706-medline-pacer-implant-pack-recall-incorrect-needle-type-in-suture.
Source Summary by GovInfoNow · govinfonow.com/recall/53706-medline-pacer-implant-pack-recall-incorrect-needle-type-in-suture · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0533-2025
Cite this page
“Medline Pacer Implant Pack Recall: Incorrect Needle Type in Suture Kits.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53706-medline-pacer-implant-pack-recall-incorrect-needle-type-in-suture. Based on FDA recall #Z-0533-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2025%22&limit=1).
Why it’s dangerous
The suture packages in some kits have incorrect needle types, sizes, or suture diameters and lengths. Using these packages without verifying the correct specifications could result in improper surgical procedures or complications during operations.
Who’s affected
Healthcare professionals using Medline's Pacer Implant Pack (REF DYNJ59194A) or Thoracotomy Morristown (REF DYNJ904220F) kits are likely affected. Surgeons and medical staff performing procedures with these kits are at the highest risk.
How to tell if you have this one
Check for the product reference numbers: DYNJ59194A (Pacer Implant Pack, 4 kits/case) or DYNJ904220F (Thoracotomy Morristown, 1 kit/case). The kits were sold with specific lot numbers and expiration dates as listed in the recall notice.
- Brand
Medline- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0532-2025 | (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.; (1) REF CDS840132O - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277; (2) REF DYNJ903016G - Lot numbers 24DBP801, exp. 8/31/2025; and 24CBJ749, exp. 11/30/2024, UDI-DI each - 10195327657154, UDI-DI case - 40195327657155. | 408 kits |
| Z-0533-2025 | (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.; (1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301. | 360 kits |
| Z-0534-2025 | Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.; Lot number 24ABO552, exp. 9/30/2025, UDI-DI each 10195327198930, UDI-DI case 40195327198931. | 48 kits |
What to do — step by step
Verify Kit Reference
Check the product reference number on the kit packaging to confirm if it is DYNJ59194A or DYNJ904220F.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Georgia, Massachusetts, New Jersey, Pennsylvania.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0533-2025 (October 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0533-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.